Clarithromycin as Adjuvant to Periodontal Debridement

Not Applicable

Completed

• Conditions: Aggressive Periodontitis
• Interventions: Drug: Placebo; Drug: Clarithromycin; Other: One-stage full-mouth ultrasonic debridement (FMUD)

• Registration Number: NCT02829983
• Lead Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

Brief Summary

To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.

Detailed Description

To assess the periodontal clinical response and the possible adverse effects of the clarithromycin combined to periodontal mechanical therapy in the treatment of patients with generalized aggressive periodontitis.Forty patients were select and randomly assigned into two groups: Group clarithromycin with 20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days; group placebo with 20 subjects that received FMUD associated with placebo. Probing depth (PD), gain in clinical attachment level (CAL) and bleeding on probing (BOP) were evaluated at baseline, 3 and 6 months post- operatively.

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2015-08
• Study Completion: 2015-11
• Study First Submitted: 2016-07-08
• Study First Submitted QC: 2016-07-08
• Study First Posted: 2016-07-12
• Results First Submitted: 2017-05-09
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-16
• Results First Posted: 2017-10-17
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• diagnosis of Generalized Aggressive Periodontitis
• presence of ≥20 teeth
• presence of ≥ 6 sites presenting probing depth (PD) ≥5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to two other non-contiguous teeth between them)
• good general health
• <35 years of age
• agree to participate in the study and sign a written consent

Exclusion Criteria

• pregnant or lactating
• suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
• received antimicrobials in the previous 6 months
• taking long-term anti-inflammatory drugs
• received a course of periodontal treatment within the last 12 months
• smoked

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo	20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
placebo group	One-stage full-mouth ultrasonic debridement (FMUD)	20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days).
clarithromycin group	One-stage full-mouth ultrasonic debridement (FMUD)	20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.
clarithromycin group	Clarithromycin	20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level	6 months	Distance from bottom of pocket to the cement-enamel junction (CEJ).

Secondary Outcome Measures

Name	Time	Method
Probing Depth	6 months	Distance from the bottom of sulcus/pocket to gingival margin