GAR: Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing

Sponsor

University of Geneva, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT02197260

Collaborator

(none)

Enrollment

Location

Arms

65.9

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Periodontitis	Drug: 3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing on Clinical, Microbiological and Systemic Response

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Protocol 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)	Drug: 3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days Systemic antibiotics after sub gingival mechanical debridement
Active Comparator: Protocol B 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)	Drug: 3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days Systemic antibiotics after sub gingival mechanical debridement

Arm

Intervention/Treatment

Experimental: Protocol 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)

Drug: 3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days

Systemic antibiotics after sub gingival mechanical debridement

Active Comparator: Protocol B

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)

Drug: 3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days

Systemic antibiotics after sub gingival mechanical debridement

Outcome Measures

Primary Outcome Measures

Number of persisting pockets >4 mm bleeding upon probing [one year after therapy]

Secondary Outcome Measures

Pocket depth of sites with baseline PD >4 mm [one year]

Other Outcome Measures

Adverse events [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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