Nonsurgical Periodontal Treatment Associated or Not With Systemic Antibiotics and Photodynamic Therapy

Study Overview
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Brief Summary
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To assess the local effect of the antimicrobial therapy using clarithromycin association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP).

Detailed Description
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The aim of the present study was to evaluate the local effect of the antimicrobial therapy using clarithromycin (CLM) association with photodynamic therapy (PDT) in the treatment of generalized aggressive periodontitis (GAgP). Sixty periodontal pockets were select and randomly assigned into four groups: Periodontal Debridement (PD) (n=15): periodontal pockets that received periodontal debridement (PD) with placebo; PD+CLM (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin; PD+PDT (n=15): periodontal pockets that received periodontal debridement associated with photodynamic therapy; PD+CLM+PDT (n=15): periodontal pockets that received periodontal debridement associated with clarithromycin and photodynamic therapy. 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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Evaluation of the Local Effect of Nonsurgical Periodontal Treatment of Generalized Aggressive Periodontitis Associated or Not With Systemic Antibiotics and Photodynamic Therapy.: a Randomized Clinical Trial

Conditions
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Aggressive Periodontitis, Generalized

Intervention / Treatment
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* Procedure: periodontal debridement
* Procedure: photodynamic therapy
* Drug: systemic clarithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of GagP presence of ≥20 teeth <35 years of age periodontal pockets with probing depth (PD) and Clinical Attachment Level (CAL) ≥ 5mm with concomitant bleeding on probing (BOP) in single-rooted teeth from different quadrants - 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 |
| --- | --- |
| Placebo Comparator: Periodontal debridement<br>Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days). | Procedure: periodontal debridement<br> <br> * Other names: Ultrassonic periodontal debridement;|
| Active Comparator: Periodontal debridement + CLM<br>Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours) for 3 days. | Procedure: periodontal debridement<br> <br> * Other names: Ultrassonic periodontal debridement;Drug: systemic clarithromycin<br> <br> * Other names: antibiotic;|
| Active Comparator: Periodontal debridement + PDT<br>Periodontal pockets that received periodontal debridement associated with placebo (members took with placebo 500 mg b.i.d. for 3 days) and a single application of PDT (Photodynamic Therapy). | Procedure: periodontal debridement<br> <br> * Other names: Ultrassonic periodontal debridement;Procedure: photodynamic therapy<br> <br> * Other names: antimicrobial photodynamic therapy;|
| Active Comparator: Periodontal debridement + CLM + PDT<br>Periodontal pockets that received periodontal debridement associated with systemic clarithromycin (500 mg - 12/12 hours for 3 days) and single application of PDT. | Procedure: periodontal debridement<br> <br> * Other names: Ultrassonic periodontal debridement;Procedure: photodynamic therapy<br> <br> * Other names: antimicrobial photodynamic therapy;Drug: systemic clarithromycin<br> <br> * Other names: antibiotic;|

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 | 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, photodynamic therapy, Antimicrobial therapy, Periodontal pocket