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Clarithromycin is an Adjunct to Scaling and Root Planing (CASRCMI)

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ClinicalTrials.gov Identifier: NCT02359721
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
J.surya prasanna, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Periodontitis Drug: tablet clarithromycin 500 mg (Clarino-500) orally Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Efficacy of Clarithromycin is an Adjunct to Scaling and Root Planing .A Clinical Microbiological and Immunological Study.
Study Start Date : January 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: test group
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
orally
Other Name: Clarino-500

No Intervention: control
scaling and root planing



Primary Outcome Measures :
  1. Efficacy of Clarithromycin, as measured by reduction Gingival bleeding [ Time Frame: 6 months ]
    0,3,6 months

  2. Efficacy of Clarithromycin, as measured by Pocket probing depth [ Time Frame: 6 months ]
  3. Efficacy of Clarithromycin, as measured by Clinical attachment gain [ Time Frame: 6 months ]
  4. c-reactive protein levels [ Time Frame: 6 months ]
  5. Pg and Aa bacterial count [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Publications of Results:
Other Publications:
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Responsible Party: J.surya prasanna, DR.J. SURYA PRASANNA, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
ClinicalTrials.gov Identifier: NCT02359721     History of Changes
Other Study ID Numbers: RADHIKA DISSERTATION
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: January 2015
Keywords provided by J.surya prasanna, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre:
Colony forming units Antimicrobial agents
Microbial colonization
Additional relevant MeSH terms:
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Clarithromycin
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors