Clinical Trial Results:
Prevention and treatment of initial rotcaries among elderly in Skåne.
Summary
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EudraCT number |
2015-005300-29 |
Trial protocol |
SE |
Global end of trial date |
19 Feb 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
25 Oct 2024
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First version publication date |
25 Oct 2024
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Other versions |
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Summary report(s) |
Effect of a single application of silver diamine fluoride on root caries after 12 months in institutionalised older adults—A randomised clinical trial |
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 |
SDF1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Malmö University
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Sponsor organisation address |
20506 Malmö, Malmö, Sweden, 20506 Malmö
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Public contact |
Dan Ericson, Malmö University, Faculty of Odontology, +46 0705432497, dan.ericson@mau.se
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Scientific contact |
Dan Ericson, Malmö University, Faculty of Odontology, +46 0705432497, dan.ericson@mau.se
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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 |
19 Feb 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Feb 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Feb 2020
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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 |
The aim of this randomized, single-blinded, placebo-controlled trial was to evaluate the additive effect of a single annual application of SDF for prevention and treatment of incipient root caries in older adult nursing home residents.
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Protection of trial subjects |
The cleaned root surfaces of the included teeth were dried with cotton gauze and a dry field was created using cotton rolls. The adjacent gingiva was protected with petroleum jelly. After mouth rinsing following the first treatment at baseline, the patients were asked to describe their experiences of taste, smell, or
other sensations during application. Their responses were recorded, along with the tooth surface color and gingival status.
Study procedures and protocols were scrutinized by the study monitor every six months. After 129 (36%) of the participants had been evaluated (by August 2018), independent data and safety monitoring were conducted with respect to efficacy and safety, in order to identify any differences between the study groups that would warrant early termination of the trial.
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Background therapy |
All participants received routine oral healthcare from the dental care provider, in accordance with risk assessment based on yearly oral health examinations. The individualized procedures included professional tooth cleaning, fluoride varnish application, and dietary and oral hygiene instruction in relation to assessed caries risk. The participants received supervised personal oral hygiene procedures including fluoride toothpaste because they were care-dependent. | ||
Evidence for comparator |
See below | ||
Actual start date of recruitment |
09 Jan 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
Sweden: 356
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Worldwide total number of subjects |
356
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EEA total number of subjects |
356
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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) |
0
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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 |
92
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85 years and over |
264
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Recruitment
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Recruitment details |
Eligible participants were recruited from January 2017 to October 2018 in nursing homes in Skåne. | |||||||||||||||
Pre-assignment
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Screening details |
Eligible individuals were identified during routine dental examination visits. The responsible medical nurse advised whether the individual was able to understand and to make an informed decision to consent to participation. Each received oral and written information about the study. | |||||||||||||||
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 |
Subject | |||||||||||||||
Blinding implementation details |
Placebo application.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Silver diamine fluoride | |||||||||||||||
Arm description |
Application of Silver diamine fluoride | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Advantage Arrest Silver Diamine Fluoride 38%, Advantage Arrest, LLC, Redmond, OR 97756, USA, Lot 16 152
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Dental solution
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Routes of administration |
Dental use
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Dosage and administration details |
The cleaned root surfaces of the included teeth were dried with cotton gauze and a dry field was created using cotton rolls. The adjacent gingiva was protected with petroleum jelly. Participants were randomly assigned to receive SDF (Advantage Arrest Silver Diamine Fluoride 38%, Advantage Arrest, LLC, Redmond, OR 97756, USA,
Lot 16 152) or placebo (tap water), applied sparingly on root surfaces with a micro applicator brush and left undisturbed for 1 minute. Participants were then allowed to rinse with water.
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Arm title
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Placebo | |||||||||||||||
Arm description |
Placebo (tap water) | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
water
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Investigational medicinal product code |
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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 |
water
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Baseline characteristics reporting groups
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Reporting group title |
overall trial
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Reporting group description |
Care home residents | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Silver diamine fluoride
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Reporting group description |
Application of Silver diamine fluoride | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo (tap water) |
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End point title |
root caries change score | |||||||||||||||||||||||||||
End point description |
The status at surface level was classified as new caries or caries progression (+1), no change (0), or caries regression/inactivation (−1) and the root caries change score is the summation of the individual surface scores within the subject.
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End point type |
Primary
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End point timeframe |
over all study
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Statistical analysis title |
Root surface status at baseline and after 12 month | |||||||||||||||||||||||||||
Statistical analysis description |
Comparison of root change score between SDF and Placebo
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Comparison groups |
Silver diamine fluoride v Placebo
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Number of subjects included in analysis |
273
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||||||||||||||||||||
P-value |
> 0.05 | |||||||||||||||||||||||||||
Method |
t-test, 2-sided | |||||||||||||||||||||||||||
Parameter type |
Mean difference (final values) | |||||||||||||||||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
At baseline directly after treatment. At 6 month monitor report.
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Assessment type |
Non-systematic | |||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
SNOMED CT | |||||||||||||||||||||
Dictionary version |
240531
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Reporting groups
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Reporting group title |
Dental hygienist operator
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Reporting group description |
Dental hygienist delivering treatment | |||||||||||||||||||||
Reporting group title |
Study monitor
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Reporting group description |
Study monitor | |||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
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/36404644 |