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Clarithromycin is an Adjunct to Scaling and Root Planing

Information source: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Periodontitis

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

Phase: Phase 4

Status: Completed

Sponsored by: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Summary

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome:

Efficacy of Clarithromycin, as measured by reduction Gingival bleeding

Efficacy of Clarithromycin, as measured by Pocket probing depth

Efficacy of Clarithromycin, as measured by Clinical attachment gain

c-reactive protein levels

Pg and Aa bacterial count

Detailed description: 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.

Eligibility

Minimum age: 30 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Related publications:

Kathariya R, Pradeep AR, Raghavendra NM, Gaikwad R. Evaluation of subgingivally delivered 0.5% clarithromycin as an adjunct to nonsurgical mechanotherapy in the management of chronic periodontitis: a short-term double blinded randomized control trial. J Investig Clin Dent. 2014 Feb;5(1):23-31. doi: 10.1111/jicd.12009. Epub 2012 Oct 25.

Bajaj P, Pradeep AR, Agarwal E, Kumari M, Naik SB. Locally delivered 0.5% clarithromycin, as an adjunct to nonsurgical treatment in chronic periodontitis with well-controlled type 2 diabetes: a randomized controlled clinical trial. J Investig Clin Dent. 2012 Nov;3(4):276-83. doi: 10.1111/j.2041-1626.2012.00168.x. Epub 2012 Sep 13.

Agarwal E, Pradeep AR, Bajaj P, Naik SB. Efficacy of local drug delivery of 0.5% clarithromycin gel as an adjunct to non-surgical periodontal therapy in the treatment of current smokers with chronic periodontitis: a randomized controlled clinical trial. J Periodontol. 2012 Sep;83(9):1155-63. doi: 10.1902/jop.2012.110600. Epub 2012 Jan 16.

Starting date: January 2012
Last updated: February 4, 2015

Page last updated: August 23, 2015

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