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Trial record 47 of 398 for:    CLARITHROMYCIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 5, 2015
First Posted Date  ICMJE February 10, 2015
Last Update Posted Date February 10, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2015)
  • Efficacy of Clarithromycin, as measured by reduction Gingival bleeding [ Time Frame: 6 months ]
    0,3,6 months
  • Efficacy of Clarithromycin, as measured by Pocket probing depth [ Time Frame: 6 months ]
  • Efficacy of Clarithromycin, as measured by Clinical attachment gain [ Time Frame: 6 months ]
  • c-reactive protein levels [ Time Frame: 6 months ]
  • Pg and Aa bacterial count [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clarithromycin is an Adjunct to Scaling and Root Planing
Official Title  ICMJE Efficacy of Clarithromycin is an Adjunct to Scaling and Root Planing .A Clinical Microbiological and Immunological Study.
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Periodontitis
Intervention  ICMJE Drug: tablet clarithromycin 500 mg (Clarino-500) orally
orally
Other Name: Clarino-500
Study Arms  ICMJE
  • 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
    Intervention: Drug: tablet clarithromycin 500 mg (Clarino-500) orally
  • No Intervention: control
    scaling and root planing
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2015)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02359721
Other Study ID Numbers  ICMJE RADHIKA DISSERTATION
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party J.surya prasanna, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Study Sponsor  ICMJE Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP