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

Chronic Periodontitis Clinical Trial

— Metro + Amoxi  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01211223
• Other study ID #: Facultad Odontologia, U Chile
• Status: Completed
• Phase: Phase 4
• First received: September 28, 2010
• Last updated: June 15, 2016
• Start date: January 2010
• Est. completion date: March 2014

Study information

• Verified date: June 2016
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Comisión Nacional de Investigación Científica y Tecnológica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2014
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Periodontitis
• Clinical and Microbiological Effects
• Periodontitis

Intervention

Drug:
• Administration of Metronidazole plus Amoxicillin
Metronidazole plus Amoxicillin after, during and after root planning

Locations

Country	Name	City	State
Chile	Facultad de Odontologia	Santiago	R Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
University of Chile	Colgate Palmolive

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Mean change in clinical attachment level (CAL)		12 months	Yes
Secondary	- Mean change in probing pocket depths (PD)		12 months	Yes