PeriodontitisPhase 4CASRCMINCT02359721
Clarithromycin is an Adjunct to Scaling and Root Planing
A Phase 4 study testing tablet clarithromycin 500 mg (Clarino-500) orally in people with Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- tablet clarithromycin 500 mg (Clarino-500) orally
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients age ranged between 30- 50 years with chronic periodontitis
- Patients with Probing Depth (PD)- >5mm, Clinical Attachment Level( CAL)- >3mm
- Systemically healthy individuals
Who cannot join
- 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
About this study
Official title: Efficacy of Clarithromycin is an Adjunct to Scaling and Root Planing .A Clinical Microbiological and Immunological Study.
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.
- Conditions
- Periodontitis
- Being tested
- tablet clarithromycin 500 mg (Clarino-500) orally
- Keywords
- Colony forming units Antimicrobial agents, Microbial colonization
- Medical subject headings
- Periodontitis, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tablet clarithromycin 500 mg (Clarino-500) orallyDrug
Also called Clarino-500
orally
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: tablet clarithromycin 500 mg (Clarino-500) orally |
| control | No intervention | scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Clarithromycin, as measured by reduction Gingival bleeding
0,3,6 months
Measured: 6 months
Efficacy of Clarithromycin, as measured by Pocket probing depth
Measured: 6 months
Efficacy of Clarithromycin, as measured by Clinical attachment gain
Measured: 6 months
c-reactive protein levels
Measured: 6 months
Pg and Aa bacterial count
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.surya prasanna, Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359721
- Sponsor's protocol ID
- RADHIKA DISSERTATION
- Acronym
- CASRCMI
- Status last verified
- Jan 2015
- First submitted
- 5 Jan 2015
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 23097216Bajaj 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 22976782Agarwal 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 22248223Raghunatha 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 23451987Pradeep 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 21529775Burrell RC, Walters JD. Distribution of systemic clarithromycin to gingiva. J Periodontol. 2008 Sep;79(9):1712-8. doi: 10.1902/jop.2008.080013.
PubMed 18771373Piccolomini 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Clarithromycin is an Adjunct to Scaling and Root Planing .A Clinical Microbiological and Immunological Study.
- ClinicalTrials.gov ID
- NCT02359721
- Acronym / sponsor ID
- CASRCMI / RADHIKA DISSERTATION
- Conditions
- Periodontitis
- Keywords
- Colony forming units Antimicrobial agents, Microbial colonization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Panineeya Mahavidyalaya Institute of Dental Sciences & Research CentreUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Drug: tablet clarithromycin 500 mg (Clarino-500) orallyBase 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 |
| control | No intervention | –scaling and root planing |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients age ranged between 30- 50 years with chronic periodontitis
- Patients with Probing Depth (PD)- >5mm, Clinical Attachment Level( CAL)- >3mm
- Systemically healthy individuals
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tablet clarithromycin 500 mg (Clarino-500) orallyAlso: Clarino-500orally | Drug | test group |
Primary outcome
Efficacy of Clarithromycin, as measured by reduction Gingival bleeding
Time frame: 6 months
0,3,6 months
Efficacy of Clarithromycin, as measured by Pocket probing depth
Time frame: 6 months
Efficacy of Clarithromycin, as measured by Clinical attachment gain
Time frame: 6 months
c-reactive protein levels
Time frame: 6 months
Pg and Aa bacterial count
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
- Background: PubMed 23097216Kathariya 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.
- Background: PubMed 22976782Bajaj 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.
- Background: PubMed 22248223Agarwal 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 publication: PubMed 23451987Raghunatha 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 publication: PubMed 21529775Pradeep 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 publication: PubMed 18771373Burrell RC, Walters JD. Distribution of systemic clarithromycin to gingiva. J Periodontol. 2008 Sep;79(9):1712-8. doi: 10.1902/jop.2008.080013.
- Results publication: PubMed 9797240Piccolomini 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tablet clarithromycin 500 mg (Clarino-500) orally in people with Periodontitis, run by Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Clarithromycin, as measured by reduction Gingival bleeding (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02359721, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.