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

Sponsor

University of Chile (Other)

Overall Status

Completed

CT.gov ID

NCT01211223

Collaborator

Colgate Palmolive (Industry)

Enrollment

Location

Arm

49.9

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Periodontitis Clinical and Microbiological Effects	Drug: Administration of Metronidazole plus Amoxicillin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Administration of Metronidazole plus Amoxicillin Metronidazole plus Amoxicillin after, during and after root planning

Arm

Intervention/Treatment

Experimental: 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

Drug: Administration of Metronidazole plus Amoxicillin

Metronidazole plus Amoxicillin after, during and after root planning

Outcome Measures

Primary Outcome Measures

- Mean change in clinical attachment level (CAL) [12 months]

Secondary Outcome Measures

- Mean change in probing pocket depths (PD) [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. 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:

1. 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