Clarithromycin is an Adjunct to Scaling and Root Planing

Study Overview
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Brief Summary
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The present study was done to evaluate the effect of clarithromycin as an adjunct to scaling and root planning at baseline, three months and six months intervals . Clinical, microbiological and immunological parameters were taken. Clinical parameters include gingival index , probing depth and clinical attachment level. In the present study, improved clinical and microbiological outcomes were attained using adjunctive clarithromycin, including GI, PD reduction, CAL gain and reductions in the frequency of detection of C-reactive protein, Pg, Aa. These results together with the recommended easy dosage and limited side effects make the use of this antibiotic in the treatment of periodontitis patients but only for a shorter period of time.

Detailed Description
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Background & Objectives: Along with conventional non-surgical periodontal therapy (NSPT) systemic antimicrobials may provide more effective treatment for chronic periodontitis by targeting tissue-invasive bacteria. The aim of this study was to evaluate the adjunctive effects of oral clarithromycin (CLM) to nonsurgical periodontal therapy for chronic periodontitis. Materials and Methods: 30 patients were categorized into two groups: test group - Base line scaling and root planing(SRP) was done. Clarithromycin tablet 500 mg( Clarino-500) was given for a period of 7 days orally two times per day. control group -only SRP done . Clinical parameters were recorded at baseline , 3 months, and six months interval .They included gingival index (GI), probing depth (PD), and clinical attachment level (CAL). Also microbial analysis of subgingival plaque samples was done at baseline, 3months and six months interval to estimate the levels of Pg and Aa bacteria using culture methods. Immunological parameter like estimation of C-Reactive protein was done in both groups at baseline 3 months and 6 months period. tests were used for statistical analysis.

Official Title
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Efficacy of Clarithromycin is an Adjunct to Scaling and Root Planing .A Clinical Microbiological and Immunological Study.

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: tablet clarithromycin 500 mg (Clarino-500) orally


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age ranged between 30- 50 years with chronic periodontitis Patients with Probing Depth (PD)- >5mm, Clinical Attachment Level( CAL)- >3mm Systemically healthy individuals Exclusion Criteria: Patients below the age of 30 years Patients who have undergone periodontal therapy 3 months prior to study Active /passive smokers Any antibiotic use 3 months prior to study Pregnant women and lactating mothers Un co- operative/ retarded patients Drug allergy/ other allergies Any systemic diseases

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test group<br>Base line scaling and root planing was done. Clarithromycin tablet 500 mg( Clarino-500) was given for a period of 7 days orally two times per day | Drug: tablet clarithromycin 500 mg (Clarino-500) orally<br>* orally<br>* Other names: Clarino-500;|
| No Intervention: control<br>scaling and root planing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Clarithromycin, as measured by reduction Gingival bleeding | 0,3,6 months | 6 months | 
| Efficacy of Clarithromycin, as measured by Pocket probing depth |  | 6 months | 
| Efficacy of Clarithromycin, as measured by Clinical attachment gain |  | 6 months | 
| c-reactive protein levels |  | 6 months | 
| Pg and Aa bacterial count |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colony forming units Antimicrobial agents, Microbial colonization