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CompletedNCT02359721CASRCMIUpdated Feb 10, 2015

Clarithromycin is an Adjunct to Scaling and Root Planing

A Phase 4 interventional study of tablet clarithromycin 500 mg (Clarino-500) orally in Periodontitis, sponsored by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre. Completed. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-10.

Sponsored by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
30 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Periodontitis

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Keywords

  • Colony forming units Antimicrobial agents
  • Microbial colonization
03

In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 30 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

Browse Periodontitis studies →

Lead sponsor

Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

  • No intervention
    control

    scaling and root planing

Interventions

  • Drugtablet clarithromycin 500 mg (Clarino-500) orally

    orally

    Also known as: Clarino-500

06

What researchers measure

Primary outcomes

  1. Efficacy of Clarithromycin, as measured by reduction Gingival bleeding

    0,3,6 months

    Time frame: 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

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 23097216 ↗
  • 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. PubMed 22976782 ↗
  • 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. PubMed 22248223 ↗
  • 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. PubMed 23451987 ↗
  • 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. PubMed 21529775 ↗
  • Burrell RC, Walters JD. Distribution of systemic clarithromycin to gingiva. J Periodontol. 2008 Sep;79(9):1712-8. doi: 10.1902/jop.2008.080013. PubMed 18771373 ↗
  • 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. PubMed 9797240 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02359721
Lead sponsor
Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
Responsible party
J.surya prasanna (DR.J. SURYA PRASANNA, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre) — Principal investigator
First posted
Feb 10, 2015
Start date
Jan 2012
Primary completion
Jan 2013
Completion
Dec 2013
Last update
Feb 10, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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