Clinical Trial Results:
The effect of systemic antibiotics on clinical and patient-centered outcomes of implant therapy and simultaneous guided bone regeneration. A randomised controlled clinical trial.
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Summary
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EudraCT number |
2013-001811-56 |
Trial protocol |
AT |
Global end of trial date |
30 Apr 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Jun 2020
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First version publication date |
04 Jun 2020
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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 |
Syst.Antibiotics&GBR
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Medical University of Graz
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Sponsor organisation address |
Billrothgasse 4, Graz, Austria, 8010
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Public contact |
Dept. of Oral Surgery & Radiology, PD. DDr. Michael Payer, 43 31638580659, mi.payer@medunigraz.at
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Scientific contact |
Dept. of Oral Surgery & Radiology, PD. DDr. Michael Payer, 43 31638580659, mi.payer@medunigraz.at
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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 |
15 May 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Apr 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Apr 2018
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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 the present study was to determine the effect of a systemic antibiotic prophylaxis regime on patient-centred outcomes and postsurgical complications in patients undergoing oral implant therapy and simultaneous guided bone regeneration.
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Protection of trial subjects |
Close monitoring of possible complications was implemented to ensure protection of trial subjects (4 follow-up visits after surgery).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
25 Nov 2014
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Long term follow-up planned |
Yes
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Long term follow-up rationale |
Safety, Efficacy | ||
Long term follow-up duration |
3 Months | ||
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 |
Iceland: 22
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Country: Number of subjects enrolled |
China: 103
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Country: Number of subjects enrolled |
Singapore: 28
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Country: Number of subjects enrolled |
Austria: 59
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Country: Number of subjects enrolled |
Australia: 41
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Worldwide total number of subjects |
253
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EEA total number of subjects |
81
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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) |
177
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From 65 to 84 years |
76
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85 years and over |
0
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Recruitment
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Recruitment details |
253 patients were screened for the study in total. 17 primarily included cases had to be excluded due to heterogenous reasons. Thus at total of 236 cases were actually enrolled and analysed. | |||||||||
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Pre-assignment
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Screening details |
253 patients were screened for the study in total. 17 primarily included cases had to be excluded due to heterogenous reasons. Thus at total of 236 cases were analysed. Randomisation into the two arms was performed at the time of consent | |||||||||
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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 |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Test group | |||||||||
Arm description |
Pre-operative antibiotics of 2 g amoxicillin were prescribed to the test group 1 hour prior to surgery and 500 mg thrice daily on days 1 to 3 after surgery. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Amoxicillin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
Pre-operative antibiotics of 2 g amoxicillin were prescribed to the test group 1 hour prior to surgery and 500 mg thrice daily on days 1 to 3 after surgery.
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Arm title
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Control group | |||||||||
Arm description |
The control group was given a placebo. Subjects were examined clinically by blinded examiners at 1, 2, 4 and 12 weeks from surgery for postoperative complications. | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule, hard
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Routes of administration |
Oral use
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Dosage and administration details |
In the control group a pre-operative placebo (containing corn starch) of 2 g was administered. An additional single dose of 500 mg of placebo was administered 8 hours after surgery and 500 mg thrice daily (8 hourly) on days 1 to 3 following implant placement and guided bone regeneration.
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 253 patients were initially screened but 236 cases were actually enrolled and analyzed. |
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
Patients who signed informed consent and with complete data | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Test group
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Reporting group description |
Pre-operative antibiotics of 2 g amoxicillin were prescribed to the test group 1 hour prior to surgery and 500 mg thrice daily on days 1 to 3 after surgery. | ||
Reporting group title |
Control group
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Reporting group description |
The control group was given a placebo. Subjects were examined clinically by blinded examiners at 1, 2, 4 and 12 weeks from surgery for postoperative complications. | ||
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End point title |
Patient-related outcome measures: pain, swelling, bruising, bleeding | |||||||||
End point description |
There was no statistically significant difference between the two treatment groups for bleeding, swelling, pain, and hematoma (all P > 0.05).
However there was a significant time effect, where the mean VAS scores decreased over time (P < 0.001). However, no significant interaction effect between the treatment groups and time suggested that the decrease in the mean VAS scores in different treatment groups was not significantly different from each other for all the variables assessed. When adjusted for the center effect, consistent results were obtained that no statistically significant differences existed between the two treatment groups for all outcomes, but for a significant time effect (data not reported).
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End point type |
Primary
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End point timeframe |
postoperative day 1-6, 7 & 14
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Statistical analysis title |
Outcome 1 | |||||||||
Statistical analysis description |
There was no statistically significant difference between the two Groups for bleeding, swelling, pain and hematoma (all p>0.05).
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Comparison groups |
Control group v Test group
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Number of subjects included in analysis |
236
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
< 0.05 | |||||||||
Method |
ANOVA | |||||||||
Confidence interval |
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Statistical analysis title |
Outcome 2 | |||||||||
Statistical analysis description |
There was no statistically significant difference in flap closure, pain, swelling, pus, and implant stability of the Operation site between the two Groups (P>0.05).
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Comparison groups |
Test group v Control group
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Number of subjects included in analysis |
236
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Chi-squared | |||||||||
Confidence interval |
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End point title |
Presence of postsurgical complications | |||
End point description |
There was no statistically significant difference in flap closure, pain, swelling, pus and implant stability of the operation site between the two treatment groups at any time (P > 0.05).
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End point type |
Secondary
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End point timeframe |
1, 2, 4 and 12 weeks postoperatively
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| No statistical analyses for this end point | ||||
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Adverse events information
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Timeframe for reporting adverse events |
From enrolment to study termination per patient
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||
Dictionary version |
22,0
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Reporting groups
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Reporting group title |
Enrolled patients
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||
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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 | |||
