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

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
tablet clarithromycin 500 mg (Clarino-500) orally
Sponsored by
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Periodontitis focused on measuring Colony forming units Antimicrobial agents, Microbial colonization

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    test group

    control

    Arm Description

    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

    scaling and root planing

    Outcomes

    Primary Outcome Measures

    Efficacy of Clarithromycin, as measured by reduction Gingival bleeding
    0,3,6 months
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2015
    Last Updated
    February 4, 2015
    Sponsor
    Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02359721
    Brief Title
    Clarithromycin is an Adjunct to Scaling and Root Planing
    Acronym
    CASRCMI
    Official Title
    Efficacy of Clarithromycin is an Adjunct to Scaling and Root Planing .A Clinical Microbiological and Immunological Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontitis
    Keywords
    Colony forming units Antimicrobial agents, Microbial colonization

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    test group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    scaling and root planing
    Intervention Type
    Drug
    Intervention Name(s)
    tablet clarithromycin 500 mg (Clarino-500) orally
    Other Intervention Name(s)
    Clarino-500
    Intervention Description
    orally
    Primary Outcome Measure Information:
    Title
    Efficacy of Clarithromycin, as measured by reduction Gingival bleeding
    Description
    0,3,6 months
    Time Frame
    6 months
    Title
    Efficacy of Clarithromycin, as measured by Pocket probing depth
    Time Frame
    6 months
    Title
    Efficacy of Clarithromycin, as measured by Clinical attachment gain
    Time Frame
    6 months
    Title
    c-reactive protein levels
    Time Frame
    6 months
    Title
    Pg and Aa bacterial count
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23097216
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22976782
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22248223
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23451987
    Citation
    Raghunatha K, George JP. Periodontal tissue and serum concentration of clarithromycin after systemic administration in patients affected by chronic periodontitis. J Periodontol. 2013 Sep;84(9):e17-22. doi: 10.1902/jop.2013.120521. Epub 2013 Mar 1.
    Results Reference
    result
    PubMed Identifier
    21529775
    Citation
    Pradeep AR, Kathariya R. Clarithromycin, as an adjunct to non surgical periodontal therapy for chronic periodontitis: a double blinded, placebo controlled, randomized clinical trial. Arch Oral Biol. 2011 Oct;56(10):1112-9. doi: 10.1016/j.archoralbio.2011.03.021. Epub 2011 May 6.
    Results Reference
    result
    PubMed Identifier
    18771373
    Citation
    Burrell RC, Walters JD. Distribution of systemic clarithromycin to gingiva. J Periodontol. 2008 Sep;79(9):1712-8. doi: 10.1902/jop.2008.080013.
    Results Reference
    result
    PubMed Identifier
    9797240
    Citation
    Piccolomini R, Catamo G, Di Bonaventura G. Bacteriostatic and bactericidal in vitro activities of clarithromycin and erythromycin against periodontopathic Actinobacillus actinomycetemcomitans. Antimicrob Agents Chemother. 1998 Nov;42(11):3000-1. doi: 10.1128/AAC.42.11.3000.
    Results Reference
    result

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