Clarithromycin is an Adjunct to Scaling and Root Planing

NCT02359721 | Completed Phase 4 DMC

• 1 other identifier: RADHIKA DISSERTATION
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis

Keywords

Colony forming units Antimicrobial agents; Microbial colonization

Outcome Measures

Primary Outcomes (5)

• Efficacy of Clarithromycin, as measured by reduction Gingival bleeding

  0,3,6 months

  6 months

• Efficacy of Clarithromycin, as measured by Pocket probing depth

  6 months

• Efficacy of Clarithromycin, as measured by Clinical attachment gain

  6 months

• c-reactive protein levels

  6 months

• Pg and Aa bacterial count

  6 months

Study Arms (2)

test group

EXPERIMENTAL

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

control

NO INTERVENTION

scaling and root planing

Interventions

tablet clarithromycin 500 mg (Clarino-500) orally DRUG

orally

Also known as: Clarino-500

test group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients age ranged between 30- 50 years with chronic periodontitis
• Patients with Probing Depth (PD)- \>5mm, Clinical Attachment Level( CAL)- \>3mm
• Systemically healthy individuals

You may not qualify if:

• 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

Sponsors & Collaborators

• Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre: lead

Related Publications (7)

• 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.

  PMID: 23097216 BACKGROUND

• 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.

  PMID: 22976782 BACKGROUND

• 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.

  PMID: 22248223 BACKGROUND

• 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.

  PMID: 23451987 RESULT

• 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.

  PMID: 21529775 RESULT

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

  PMID: 18771373 RESULT

• 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.

  PMID: 9797240 RESULT

MeSH Terms

Conditions

Periodontitis; Communicable Diseases

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR.J. SURYA PRASANNA

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: February 10, 2015
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 10, 2015

Record last verified: 2015-01