Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing

NCT ID: NCT02197260

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2014-03-31

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.

Conditions

Chronic Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Systemic antibiotics after sub gingival mechanical debridement

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)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

Systemic antibiotics after sub gingival mechanical debridement

Interventions

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

Systemic antibiotics after sub gingival mechanical debridement

Intervention Type: DRUG

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Geneva, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Andrea Mombelli

Prof. Dr.med.dent.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrea Mombelli, Dr.med.dent.

Role: PRINCIPAL_INVESTIGATOR

University of Geneva

Locations

University of Geneva School of Dental Medicine

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

References

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.

Reference Type: RESULT

PMID: 24452825 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26604272 (View on PubMed)

Other Identifiers

2008DR4228

Identifier Type: OTHER

Identifier Source: secondary_id

320030-122089

Identifier Type: -

Identifier Source: org_study_id