Clarithromycin as Adjuvant to Periodontal Debridement

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clarithromycin as Adjuvant to Periodontal Debridement in the Treatment of Generalized Aggressive Periodontitis: Randomized Clinical Trial

Conditions
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Aggressive Periodontitis

Intervention / Treatment
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* Drug: Clarithromycin
* Drug: Placebo
* Other: One-stage full-mouth ultrasonic debridement (FMUD)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: clarithromycin group<br>20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days. | Drug: Clarithromycin<br>* Use of 500mg of Clarithromycin twice a day for 3 days<br>* Other names: macrolide;Other: One-stage full-mouth ultrasonic debridement (FMUD)<br>* One session of Periodontal debridement using ultrasonic device.<br>|
| Placebo Comparator: placebo group<br>20 subjects that received FMUD associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). | Drug: Placebo<br>* Use of placebo tablets twice a day for 3 days.<br>Other: One-stage full-mouth ultrasonic debridement (FMUD)<br>* One session of Periodontal debridement using ultrasonic device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Attachment Level | Distance from bottom of pocket to the cement-enamel junction (CEJ). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Depth | Distance from the bottom of sulcus/pocket to gingival margin | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clarithromycin, periodontal debridement, aggressive periodontitis