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Chronic Periodontitis | 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 research study

What is the primary objective of this study?

• 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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Periodontitis

Clinical and Microbiological Effects

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Study Status

Completed

Start Date: January 2010

Completed Date: March 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: - Mean change in clinical attachment level (CAL)

Secondary Outcome: - Mean change in probing pocket depths (PD)

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University of Chile

Collaborator: Colgate Palmolive

More information:https://clinicaltrials.gov/show/NCT01211223

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