Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis.

NCT ID: NCT01211223

Last Updated: 2016-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-03-31

Brief Summary

• Background: Peridontitis is a group of diseases with complex bacterial etiology that affects a large proportion of the Chilean and worldwide population. Its treatment, based on an anti-infective mechanical therapy including scaling and root planning procedures, has been highly effective in numerous short and long term clinical trials. The use of adjunctive systemic antibiotics has shown significant improvements in the initial therapy results of specific periodontal disease types or patient profiles.

The synergic combination of Metronidazole plus amoxicillin has been widely and successfully used for the treatment of aggressive and severe chronic periodontitis, demonstrating additional benefits in clinical and microbiological parameters over scaling and root planning alone. However, and despite its proven efficacy, there is a lack of evidence that evaluates the impact of antimicrobials intake at different times of the mechanical treatment, emphasizing the necessity of a study that compares, simultaneously, the variation of the adjunctive antibiotic effects when they are administered in different moments through the periodontal therapy course.

Conditions

Chronic Periodontitis; Clinical and Microbiological Effects

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Scaling and root planning + placebo + antibiotics

• Scaling and root planning + placebo
• Scaling and root planning + metronidazole plus amoxicillin
• Metronidazole plus amoxicillin + scaling and root planning

Group Type: EXPERIMENTAL

Administration of Metronidazole plus Amoxicillin

Intervention Type: DRUG

Metronidazole plus Amoxicillin after, during and after root planning

Interventions

Administration of Metronidazole plus Amoxicillin

Metronidazole plus Amoxicillin after, during and after root planning

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• a) age of 35 years old or more, b) at least 3 molars in the mouth, c) at least one site in three of the four quadrants with clinical attachment loss ≥ 3mm; d) at least 4 sites in different teeth with probing depth and clinical attachment level ≥ 6mm and bleeding on probing and at least 14 tooth present in the mouth

Exclusion Criteria

• a) previous professional root planning; b) systemic/topic antibiotic or antiinflammatory treatment, at least 6 months prior to the initiation of the study; c) immunosuppression or need for antibiotic coverage for routine dental therapy; d) systemic condition that could affect the progression of periodontal disease (diabetes); e) pregnancy or lactation; e) allergy or intolerance to metronidazole or amoxicillin; f) smokers

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: collaborator

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Jorge Gamonal

Academic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Facultad de Odontologia

Santiago, R Metropolitana, Chile

Countries

Chile

Other Identifiers

Facultad Odontologia, U Chile

Identifier Type: -

Identifier Source: org_study_id