Clinical Trial Results:
A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services.
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Summary
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EudraCT number |
2009-010725-39 |
Trial protocol |
GB |
Global end of trial date |
22 Jun 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Mar 2018
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First version publication date |
03 Mar 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
08/14/19
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Additional study identifiers
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ISRCTN number |
ISRCTN36180119 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Belfast Health and Social Care Trust
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Sponsor organisation address |
A Floor, Belfast City Hospital, Lisburn Road, Belfast, United Kingdom, BT9 7AB
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Public contact |
Professor Martin Tickle, University of Manchester, +44(0) 161 275 6610, martin.tickle@manchester.ac.uk
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Scientific contact |
Professor Martin Tickle, University of Manchester, +44(0) 161 275 6610, martin.tickle@manchester.ac.uk
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Sponsor organisation name |
University of Manchester
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Sponsor organisation address |
Oxford Road, Manchester, United Kingdom, M13 9PL
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Public contact |
Professor Martin Tickle, University of Manchester, +44(0) 1612756610, martin.tickle@manchester.ac.uk
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Scientific contact |
Professor Martin Tickle, University of Manchester, +44(0) 1612756610, martin.tickle@manchester.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Jul 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
22 Jun 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
22 Jun 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To compare over a 3 year period the effectiveness of 22,600 ppm fluoride varnish, 1,450 ppm fluoride toothpaste, toothbrush and standardised health education, provided twice a year, as a preventive package, with standardised health education alone provided twice a year in:
•preventing the conversion of children from caries−free to caries−active states in the primary dentition
•reducing the number of carious surfaces (caries into dentine) in the primary dentition in children who convert from caries free to caries active states
•preventing episodes of pain and extraction of primary teeth in 2 and 3 year−old children who are caries free at baseline and who attend primary care dental services.
To compare over a 3 year period the costs of dental care in the group receiving 22,600 ppm fluoride varnish, 1,450 ppm fluoride toothpaste, toothbrush and standardised health education, provided twice a year as a preventive package, with the group receiving standardised health education alone.
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Protection of trial subjects |
The risks for children in the intervention group included allergic responses to the varnish, therefore children who had been hospitalised due to allergic reactions were excluded from the trial. There was also a risk of children in the intervention group developing fluorosis, however this risk was unlikely as the varnish was professionally applied and standardised advice on the safe use of toothpaste was given to all participants. An independent data monitoring and ethics committed was also convened for the trial.
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Background therapy |
Not Applicable | ||
Evidence for comparator |
The comparator was standardised health education advice. | ||
Actual start date of recruitment |
12 Apr 2011
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 1248
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Worldwide total number of subjects |
1248
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EEA total number of subjects |
1248
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
1248
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Recruitment took place between 12/04/2011 and 29/06/2012 from 22 general dental practices in Northern Ireland. 1248 children aged 2-3 years and who were caries free were recruited into the trial, exceeding the planned sample size of 1200. | ||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 2455 were screened by Community Dental Service dentists according to the trial inclusion/exclusion criteria. Children were excluded if they had a past history of fillings or extractions due to caries, fissure sealants on primary molar teeth, a history of severe allergic reactions requiring hospitalization or participating in an IMP study | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Single blind | ||||||||||||||||||
Roles blinded |
Assessor [1] | ||||||||||||||||||
Blinding implementation details |
The study was a two-arm, parallel-group, randomised controlled trial, with an allocation ratio of 1 : 1. Randomisation was undertaken by the clinical trials unit using randomised permuted blocks. Children/parents and general dental practice staff were not blinded; however, the Community Dental Service dentists who completed the outcome assessment were blinded to treatment allocation.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Intervention | ||||||||||||||||||
Arm description |
The intervention was composite in nature, comprising a varnish containing 22,600 parts per million (p.p.m.) fluoride, a toothbrush and a 50-ml tube of toothpaste containing 1450 p.p.m. fluoride; plus standardised, evidence-based prevention advice provided at 6-monthly intervals over 3 years. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Duraphat
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Investigational medicinal product code |
PL 00049/0042
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Other name |
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Pharmaceutical forms |
Dental suspension
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Routes of administration |
Dental use
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Dosage and administration details |
22,600 ppm of fluoride varnish was applied to the dried primary teeth of the children by a participating dentist following the product brochure, and a fluoride varnish application protocol which described the process of application for participating dentists. Up to 0.25 ml (=5.65 mg Fluoride) was applied twice a year at each 6 month visit and in total children would have received a maximum of 6 applications over the duration of the trial.
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Arm title
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Control | ||||||||||||||||||
Arm description |
The control group received standardised health education advice alone at 6-monthly intervals over 3 years. | ||||||||||||||||||
Arm type |
Advice Only | ||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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| Notes [1] - The roles blinded appear inconsistent with a simple blinded trial. Justification: Children, parents and the general dental practice staff were not blinded. However the Community Dental staff who completed the outcome assessment were blinded to treatment allocation. |
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Baseline characteristics reporting groups
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Reporting group title |
Intervention
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Reporting group description |
The intervention was composite in nature, comprising a varnish containing 22,600 parts per million (p.p.m.) fluoride, a toothbrush and a 50-ml tube of toothpaste containing 1450 p.p.m. fluoride; plus standardised, evidence-based prevention advice provided at 6-monthly intervals over 3 years. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
The control group received standardised health education advice alone at 6-monthly intervals over 3 years. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Intervention
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Reporting group description |
The intervention was composite in nature, comprising a varnish containing 22,600 parts per million (p.p.m.) fluoride, a toothbrush and a 50-ml tube of toothpaste containing 1450 p.p.m. fluoride; plus standardised, evidence-based prevention advice provided at 6-monthly intervals over 3 years. | ||
Reporting group title |
Control
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Reporting group description |
The control group received standardised health education advice alone at 6-monthly intervals over 3 years. | ||
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End point title |
Conversion from caries free to caries active | |||||||||
End point description |
The primary outcome, the number (percentage) of children who converted to caries active over the trial.
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End point type |
Primary
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End point timeframe |
3 years
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Statistical analysis title |
Conversion of caries free to caries active | |||||||||
Statistical analysis description |
A logistic regression model was fitted adjusting for age and socioeconomic status measured by MDM 2010 quintiles.
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Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
1096
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
= 0.11 | |||||||||
Method |
Regression, Logistic | |||||||||
Parameter type |
Odds ratio (OR) | |||||||||
Point estimate |
0.81
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.64 | |||||||||
upper limit |
1.04 | |||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.1
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End point title |
Number of decayed, missing, filled tooth surfaces in caries active children | ||||||||||||
End point description |
The number of decayed, missing, filled tooth surfaces was calculated for each child, who were caries active.
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End point type |
Secondary
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End point timeframe |
3 years
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| Notes [1] - Caries active children [2] - Caries active children |
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Statistical analysis title |
Decayed, missing filled tooth surfaces | ||||||||||||
Statistical analysis description |
A multiple linear regression analysis adjusted for age and socioeconomic status measured by MDM 2010 quintiles.
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Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
400
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.007 | ||||||||||||
Method |
Regression, Linear | ||||||||||||
Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-2.29
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-3.96 | ||||||||||||
upper limit |
-0.63 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.85
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End point title |
Number of extracted teeth in caries active children | ||||||||||||
End point description |
The number of extracted teeth was calculated for each child who was caries active.
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End point type |
Secondary
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End point timeframe |
3 years
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| Notes [3] - Caries active children [4] - Caries active children |
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Statistical analysis title |
Number of extracted teeth | ||||||||||||
Statistical analysis description |
A negative binomial model was fitted for the number of extracted teeth, which indicated significant overdispersion and was not statistically significant. A post hoc analysis on the number of children who had teeth extracted was undertaken for the children who were caries active.
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Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
400
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.95 | ||||||||||||
Method |
Negative binomial regression | ||||||||||||
Parameter type |
Negative binomial regression coefficient | ||||||||||||
Point estimate |
-0.03
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.88 | ||||||||||||
upper limit |
0.82 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.43
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End point title |
Number of caries active children with extracted teeth | |||||||||
End point description |
Number of caries active children with teeth extracted.
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End point type |
Secondary
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End point timeframe |
3 years
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| Notes [5] - Caries active children [6] - Caries active children |
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Statistical analysis title |
Number of children with teeth extracted | |||||||||
Statistical analysis description |
The planned negative binomial regression model indicated overdispersion. A logistic regression model was fitted adjusting for age and socioeconomic status measured by MDM 2010 quintiles.
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Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
400
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Analysis specification |
Post-hoc
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Analysis type |
equivalence | |||||||||
P-value |
= 0.56 | |||||||||
Method |
Regression, Logistic | |||||||||
Parameter type |
Odds ratio (OR) | |||||||||
Point estimate |
0.84
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.45 | |||||||||
upper limit |
1.54 | |||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.26
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End point title |
Number of episodes of pain | ||||||||||||
End point description |
Number of episodes of pain for all children.
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End point type |
Secondary
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End point timeframe |
3 years
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| Notes [7] - All children [8] - All children |
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Statistical analysis title |
Number of episodes of pain | ||||||||||||
Statistical analysis description |
A negative binomial regression model was fitted adjusting for caries status, age and socioeconomic status measured by MDM 2010 quintiles. There was significant overdispersion and this was not statistically significant. A post hoc analysis on the number of children having pain was also undertaken.
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Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
1096
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.81 | ||||||||||||
Method |
negative binomial regression | ||||||||||||
Parameter type |
negative binomial regression coefficient | ||||||||||||
Point estimate |
-0.03
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.32 | ||||||||||||
upper limit |
0.25 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.15
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End point title |
Number of children who had pain | |||||||||
End point description |
Number of children who had pain.
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End point type |
Secondary
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End point timeframe |
3 years
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| Notes [9] - All children [10] - All children |
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Statistical analysis title |
Number of children who had pain | |||||||||
Statistical analysis description |
A logistic regression adjusted for caries status, age and socioeconomic status measured by MDM 2010 quintiles was undertaken for the number of children with pain.
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Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
1096
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Analysis specification |
Post-hoc
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Analysis type |
equivalence | |||||||||
P-value |
= 0.74 | |||||||||
Method |
Regression, Logistic | |||||||||
Parameter type |
Odds ratio (OR) | |||||||||
Point estimate |
0.95
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.69 | |||||||||
upper limit |
1.3 | |||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.15
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End point title |
Number of serious adverse events | ||||||||||||
End point description |
Number of serious adverse events in all children, over 3 years.
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End point type |
Secondary
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End point timeframe |
Over 3 years
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| Notes [11] - All children randomised [12] - All children randomised |
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Statistical analysis title |
Number of Serious Adverse Events | ||||||||||||
Statistical analysis description |
A negative binomial analysis was fitted, adjusting for age and socioeconomic status measured by MDM 2010 quintiles. There was significant overdispersion and a logistic regression model was fitted post hoc for whether a child had a SAE or not.
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Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
1248
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.42 | ||||||||||||
Method |
Negative binomial regression | ||||||||||||
Parameter type |
Negative binomial regression coefficient | ||||||||||||
Point estimate |
0.19
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.27 | ||||||||||||
upper limit |
0.65 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.24
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End point title |
Number of children having serious adverse events | |||||||||
End point description |
Number of children randomized having a serious adverse event over 3 years.
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End point type |
Secondary
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End point timeframe |
Over 3 years
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| Notes [13] - All children randomised [14] - All children randomised |
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Statistical analysis title |
Number of children who had SAEs | |||||||||
Statistical analysis description |
A logistic regression model was fitted, adjusting for age and socioeconomic status measured by MDM 2010 quintiles. This was not statistically significant.
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Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
1248
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Analysis specification |
Post-hoc
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Analysis type |
equivalence | |||||||||
P-value |
= 0.36 | |||||||||
Method |
Regression, Logistic | |||||||||
Parameter type |
Odds ratio (OR) | |||||||||
Point estimate |
1.23
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Confidence interval |
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level |
95% | |||||||||
sides |
2-sided
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lower limit |
0.79 | |||||||||
upper limit |
1.94 | |||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
0.28
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End point title |
Mean difference health service cost/mean difference in proportion caries free | ||||||||||||
End point description |
Incremental cost-effectiveness as difference in health service costs divided by the proportion caries free intervention vs control.
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End point type |
Secondary
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End point timeframe |
3 Years
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Statistical analysis title |
Incremental cost-effectiveness | ||||||||||||
Statistical analysis description |
Incremental cost-effectiveness. A sampling distribution for the incremental cost-effectiveness ratio was simulated based on a bootstrapped sample. The 2.5 and 97.5 percentiles for the ratio were used to establish the 95% confidence interval for the distribution.
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Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
1096
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.05 | ||||||||||||
Method |
Incremental cost-effectiveness ratio | ||||||||||||
Parameter type |
Incremental cost-effectiveness ratio | ||||||||||||
Point estimate |
-2092.59
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-30100.4 | ||||||||||||
upper limit |
27921.8 | ||||||||||||
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End point title |
Mean difference in health service cost/mean difference in number of carious surfaces | ||||||||||||
End point description |
Incremental cost-effectiveness as difference in health service costs divided by the number of carious surfaces intervention vs control.
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End point type |
Secondary
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End point timeframe |
3 Years
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Statistical analysis title |
Incremental cost-effectiveness | ||||||||||||
Statistical analysis description |
Incremental cost-effectiveness. A sampling distribution for the incremental cost-effectiveness ratio was simulated based on a bootstrapped sample. The 2.5 and 97.5 percentiles for the ratio were used to establish the 95% confidence interval for the distribution.
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Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
1096
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.05 | ||||||||||||
Method |
Incremental cost effectiveness ratio | ||||||||||||
Parameter type |
Incremental cost effectiveness ratio | ||||||||||||
Point estimate |
-250.58
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-454.39 | ||||||||||||
upper limit |
-79.52 | ||||||||||||
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End point title |
Mean difference in health service cost/mean difference in number of episodes of pain | ||||||||||||
End point description |
Incremental cost-effectiveness as difference in health service costs divided by the number of episodes of pain intervention vs control.
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End point type |
Secondary
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End point timeframe |
3 Years
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Statistical analysis title |
Incremental cost-effectiveness | ||||||||||||
Statistical analysis description |
Incremental cost-effectiveness. A sampling distribution for the incremental cost-effectiveness ratio was simulated based on a bootstrapped sample. The 2.5 and 97.5 percentiles for the ratio were used to establish the 95% confidence interval for the distribution.
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Comparison groups |
Intervention v Control
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Number of subjects included in analysis |
1096
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||
P-value |
= 0.05 | ||||||||||||
Method |
Incremental cost-effectiveness ratio | ||||||||||||
Parameter type |
Incremental cost-effectiveness ratio | ||||||||||||
Point estimate |
-259.07
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-14664 | ||||||||||||
upper limit |
14941.6 | ||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
The adverse event (AE) reporting period for the trial began upon enrolment in to the study and ended at the 36 month visit. All SAEs were to be reported to the clinical trials unit within 24 hours of the local investigator becoming aware of the event.
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Adverse event reporting additional description |
All adverse events (AEs) were recorded and once causality was determined only adverse reactions (ARs) and SAEs were reported to the clinical trials unit. Due to small numbers a breakdown of term is not provided for serious and non-serious AEs.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
NICTC | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4
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Reporting groups
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Reporting group title |
Intervention
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Reporting group description |
The intervention was composite in nature, comprising a varnish containing 22,600 parts per million (p.p.m.) fluoride, a toothbrush and a 50-ml tube of toothpaste containing 1450 p.p.m. fluoride; plus standardised, evidence-based prevention advice provided at 6-monthly intervals over 3 years. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Control
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Reporting group description |
The control group received standardised caries prevention advice alone at 6-monthly intervals over 3 years. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 1% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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16 Jul 2010 |
Amendment 1 (substantial) was for the amendment of protocol version 12_12/05/2009 to protocol version 13_23/06/2010.
This also included the delegation of signing authority for applications/submissions to MHRA and Ethics from Professor Martin Tickle as Chief Investigator to Dr Michael Donaldson the trial Principal Investigator. |
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23 Mar 2011 |
Amendment 2 (substantial) was submitted to ethics only. This was for the addition of a participant ID card. |
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22 Dec 2011 |
Amendment 3 (substantial) was for the amendment of protocol version 13_23/06/2010 to protocol version 14_19/08/2011. |
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16 Jun 2014 |
Amendment 5 (substantial) was submitted to ethics only. This was for the addition of a supplementary study to examine how being part of the trial impacted on oral health related parenting practices. |
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21 Jul 2014 |
Amendment 6 (substantial) was submitted to ethics only. This was for the addition of a letter to parents in advance of the 36 month visit. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/27685609 http://www.ncbi.nlm.nih.gov/pubmed/28375708 http://www.ncbi.nlm.nih.gov/pubmed/28521109 |
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