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

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ClinicalTrials.gov Identifier: NCT02197260
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Andrea Mombelli, University of Geneva, Switzerland

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.

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Study Type : Interventional  (Clinical Trial)
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 : September 2008
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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




Primary Outcome Measures :
  1. Number of persisting pockets >4 mm bleeding upon probing [ Time Frame: one year after therapy ]

Secondary Outcome Measures :
  1. Pocket depth of sites with baseline PD >4 mm [ Time Frame: one year ]

Other Outcome Measures:
  1. Adverse events [ Time Frame: one year ]


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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02197260


Locations
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Switzerland
University of Geneva School of Dental Medicine
Geneva, Switzerland, CH-1205
Sponsors and Collaborators
University of Geneva, Switzerland
Investigators
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Principal Investigator: Andrea Mombelli, Dr.med.dent. University of Geneva

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrea Mombelli, Prof. Dr.med.dent., University of Geneva, Switzerland
ClinicalTrials.gov Identifier: NCT02197260     History of Changes
Other Study ID Numbers: 320030-122089
2008DR4228 ( Other Identifier: Swissmedic )
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014
Keywords provided by Andrea Mombelli, University of Geneva, Switzerland:
Periodontitis
amoxicillin
metronidazole
case management
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Amoxicillin
Metronidazole
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents