Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing

Chronic Periodontitis Clinical Trial

— GAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02197260
• Other study ID #: 320030-122089
• Secondary ID: 2008DR4228
• Status: Completed
• Phase: Phase 4
• First received: July 18, 2014
• Last updated: July 21, 2014
• Start date: September 2008
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: University of Geneva, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Periodontitis

Intervention

Drug:
• 3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days
Systemic antibiotics after sub gingival mechanical debridement

Locations

Country	Name	City	State
Switzerland	University of Geneva School of Dental Medicine	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University of Geneva, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Almaghlouth AA, Cionca N, Cancela JA, Décaillet 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 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		one year	Yes
Primary	Number of persisting pockets >4 mm bleeding upon probing		one year after therapy	No
Secondary	Pocket depth of sites with baseline PD >4 mm		one year	No