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

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications of Results:

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.

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.

Burrell RC, Walters JD. Distribution of systemic clarithromycin to gingiva. J Periodontol. 2008 Sep;79(9):1712-8. doi: 10.1902/jop.2008.080013 .

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.

Other 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.

• 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
• 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:

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