Antimicrobial Therapy as Adjunct to Periodontal Treatment: Effect of Timing

NCT02197260 | Completed Phase 4

• 2 other identifiers: 320030-1220892008DR4228
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Periodontitis; amoxicillin; metronidazole; case management

Outcome Measures

Primary Outcomes (1)

• Number of persisting pockets >4 mm bleeding upon probing

  one year after therapy

Secondary Outcomes (1)

• Pocket depth of sites with baseline PD >4 mm

  one year

Other Outcomes (1)

• Adverse events

  one year

Study Arms (2)

Protocol A

EXPERIMENTAL

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

Protocol B

ACTIVE COMPARATOR

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

Interventions

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

Systemic antibiotics after sub gingival mechanical debridement

Protocol A; Protocol B

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Geneva, Switzerland: lead

Study Sites (1)

University of Geneva School of Dental Medicine

Geneva, Canton of Geneva, CH-1205, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 24452825 RESULT

• 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.

  PMID: 26604272 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis; Periodontitis

Interventions

Metronidazole; Amoxicillin

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Andrea Mombelli, Dr.med.dent.

  University of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.med.dent.

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 22, 2014
• Study Start: September 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

CH (1)