Back to resultsAntimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing (GAR)
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis focused on measuring Periodontitis, amoxicillin, metronidazole, case management
Eligibility Criteria
Inclusion Criteria:
- Untreated moderate to advanced periodontitis (at least 4 teeth with a probing pocket depth (PD) >4 mm, clinical attachment loss of at least 2 mm and radiographic evidence of bone loss)
- Presence of at least 12 scorable teeth (not including 3rd molars, teeth with orthodontic appliances, bridges, crowns or implants)
- Aggregatibacter actinomycetemcomitans-positive
Exclusion Criteria:
- Systemic illnesses (i.e. diabetes mellitus, cancer, HIV, bone metabolic diseases or disorders that compromise wound healing, radiation or immunosuppressive therapy)
- Pregnancy or lactation
- Systemic antibiotics taken within the previous two months
- Use of non-steroid anti-inflammatory drugs
- Confirmed or suspected intolerance to 5-nitroimidazole-derivatives or amoxicillin subgingival SRP or surgical periodontal therapy in the last year
Sites / Locations
- University of Geneva School of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Protocol A
Protocol B
Arm Description
Antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the first, non-surgical phase of periodontal therapy (T1), and placebo during the second, surgical phase (T2)
Placebo during the first, non-surgical phase of periodontal therapy (T1), and antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the second, surgical phase (T2)
Outcomes
Primary Outcome Measures
Number of persisting pockets >4 mm bleeding upon probing
Secondary Outcome Measures
Pocket depth of sites with baseline PD >4 mm
Full Information
NCT ID
NCT02197260
First Posted
July 18, 2014
Last Updated
July 21, 2014
Sponsor
University of Geneva, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT02197260
Brief Title
Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing
Acronym
GAR
Official Title
Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing on Clinical, Microbiological and Systemic Response
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Geneva, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
It is common practice to carry out the therapy of periodontal diseases in two phases. In a first, non-surgical phase, bacterial deposits on tooth surfaces (plaque and calculus) are removed using a cleaning method called "scaling and root planing" (SRP). After three to six months the case is evaluated and, if necessary, further treatment is provided, usually taking a more aggressive, surgical approach. Beneficial effects of adjunctive systemic antibiotics on clinical outcomes have been shown repeatedly but specific indications for antibiotics in subgroups of diseased patients, and the optimal timing of antimicrobial therapy, continue to be issues of a long lasting controversy.This study assessed the differential outcomes of periodontal therapy supplemented with amoxicillin-metronidazole during either the non-surgical or the surgical treatment phase.
Detailed Description
Single center, randomized placebo controlled crossover clinical trial with a one-year follow-up. Eighty participants with Aggregatibacter actinomycetemcomitans-associated chronic or aggressive periodontitis were randomized into two treatment groups. A: Antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the first, non-surgical phase of periodontal therapy (T1), and placebo during the second, surgical phase (T2). B: Placebo during T1, and antibiotics during T2. Persistence of sites with a probing depth (PD) >4 mm and bleeding on probing (BOP) was the primary outcome. Evaluations were made three months after T1, as well as 6 and 12 months after T2.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
Keywords
Periodontitis, amoxicillin, metronidazole, case management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Protocol A
Arm Type
Experimental
Arm Description
Antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the first, non-surgical phase of periodontal therapy (T1), and placebo during the second, surgical phase (T2)
Arm Title
Protocol B
Arm Type
Active Comparator
Arm Description
Placebo during the first, non-surgical phase of periodontal therapy (T1), and antibiotics (3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days) during the second, surgical phase (T2)
Intervention Type
Drug
Intervention Name(s)
3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days
Intervention Description
Systemic antibiotics after sub gingival mechanical debridement
Primary Outcome Measure Information:
Title
Number of persisting pockets >4 mm bleeding upon probing
Time Frame
one year after therapy
Secondary Outcome Measure Information:
Title
Pocket depth of sites with baseline PD >4 mm
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Adverse events
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Untreated moderate to advanced periodontitis (at least 4 teeth with a probing pocket depth (PD) >4 mm, clinical attachment loss of at least 2 mm and radiographic evidence of bone loss)
Presence of at least 12 scorable teeth (not including 3rd molars, teeth with orthodontic appliances, bridges, crowns or implants)
Aggregatibacter actinomycetemcomitans-positive
Exclusion Criteria:
Systemic illnesses (i.e. diabetes mellitus, cancer, HIV, bone metabolic diseases or disorders that compromise wound healing, radiation or immunosuppressive therapy)
Pregnancy or lactation
Systemic antibiotics taken within the previous two months
Use of non-steroid anti-inflammatory drugs
Confirmed or suspected intolerance to 5-nitroimidazole-derivatives or amoxicillin subgingival SRP or surgical periodontal therapy in the last year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Mombelli, Dr.med.dent.
Organizational Affiliation
University of Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Geneva School of Dental Medicine
City
Geneva
ZIP/Postal Code
CH-1205
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24452825
Citation
Almaghlouth AA, Cionca N, Cancela JA, Decaillet F, Courvoisier DS, Giannopoulou C, Mombelli A. Effect of periodontal treatment on peak serum levels of inflammatory markers. Clin Oral Investig. 2014 Dec;18(9):2113-21. doi: 10.1007/s00784-014-1187-4. Epub 2014 Jan 23.
Results Reference
result
PubMed Identifier
26604272
Citation
Giannopoulou C, Cionca N, Almaghlouth A, Cancela J, Courvoisier DS, Mombelli A. Systemic Biomarkers in 2-Phase Antibiotic Periodontal Treatment: A Randomized Clinical Trial. J Dent Res. 2016 Mar;95(3):349-55. doi: 10.1177/0022034515618949. Epub 2015 Nov 24.
Results Reference
derived
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Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing
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