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
About this trial
This is an interventional supportive care trial for Periodontitis focused on measuring Colony forming units Antimicrobial agents, Microbial colonization
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
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
NCT ID
NCT02359721
First Posted
January 5, 2015
Last Updated
February 4, 2015
Sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
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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Clarithromycin is an Adjunct to Scaling and Root Planing
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