Locally Delivered Minocycline in Advanced Periodontitis

Study Overview
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Brief Summary
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Local drug delivery provides higher concentrations in the availability of the drug at the specific infected sites with the advantage of sustained release. Periocline is a long acting , sustained release local drug delivery system consisting of 2% minocycline hydrochloride in an ointment containing microcapsule type particles. Periocline contains 20mg of minocycline in 0.5 gm of gel in a disposable polypropylene applicator (2% minocycline HCl). Research has yielded promising results with the local application of minocycline in the treatment of periodontal disease, compared with other non-surgical therapies. However, there is scarcity of reports on the use of local delivery agents with respect to new range of putative pathogens in advanced periodontitis, wherein the tissue invasive anaerobic organisms are present and possibly compromised host response, hence resulting in an exaggerated breakdown of periodontal tissues at the affected sites. The effect of Minocycline on new putative pathogens, such as Filifactor alocis and oral phylotypes of phyla Synergistetes and TM7 (referred to hereafter as oral Synergistetes and oral TM7s), has not been investigated yet. Hence, the aim of the present study is to evaluate the efficacy of a local delivery agent containing minocycline (Periocline, Sunstar, Japan) as an adjunct to SRP in the treatment of deep periodontal pockets around teeth in advanced periodontitis and the antimicrobial effect on the red complex and the new putative pathogens.

Detailed Description
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The subjects for this randomized controlled, parallel arm study will be selected from the primary health care in the Faculty of Dentistry, MAHSA University. In this clinical trial, 50 patients with advanced periodontitis will be enrolled in the study.

Official Title
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Efficacy of Locally Delivered Minocycline in Advanced Periodontitis. A Clinico-microbiological Study

Conditions
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Periodontitis, Adult

Intervention / Treatment
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* Drug: Minocycline Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: systematically healthy patients with age range between 20- 60 years, diagnosed with untreated Advanced Periodontitis with a pocket depth ≥6mm around two or more teeth, in two or more quadrants. Exclusion Criteria: Patients given antibiotics or anti-inflammatory drugs in the past 6 months, allergic to tetracycline, pregnant or nursing females, those using chlorhexidine or any other mouth rinse

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minocycline<br>Minocycline gel | Drug: Minocycline Hydrochloride<br>* Administration of Periocline gel into the periodontal pockets will be carried out until it overflows the pockets<br>* Other names: Periocline;|
| Placebo Comparator: Placebo<br>Similar gel without the active agent | Drug: Minocycline Hydrochloride<br>* Administration of Periocline gel into the periodontal pockets will be carried out until it overflows the pockets<br>* Other names: Periocline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Probing pocket depth (PPD) | Periodontal pocket is measured from the gingival margin to the base of the periodontal pocket using a UNC periodontal probe (which is graduated from 1mm to 15mm). The measurement of periodontal pocket depth is a continuous scale. PPD is taken at 6 points on each tooth. The mean of the PPD will be obtained for each patient and subjected to statistical analysis. | baseline to 12 weeks | 
| Change in the numbers of Periodontal pathogens | Plaque samples taken from periodontal pockets on paper points will be first stored and later analysed for the presence and number of periopathogens using quantative Polymerase Chain Reaction (q-PCR). The following periodontal pathogens will be assessed: Red complex (Porphyromonas gingivalis, Tannerella forsythia,and Treponema denticola) Filifactor alocis, oral phylotypes of phyla Synergistetes Phylum TM7 | baseline to 12 weeks | 
| Clinical Attachment Levels (CAL) | change in CAL | baseline, 6 weeks and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | change in Plaque scores (Silness and Loe Plaque index, 1964) The score ranges from 0-3 and it is a continuous scale. '0' - no plaque '1' - thin plaque which is not visible by naked eye '2' - Moderate accumulation plaque seen by naked eye '3' - abundance of plaque. Calculation total score /number of surfaces examined = Index score for each patient. Mean plaque score is calculated for all the patients. | baseline to 12 weeks | 
| Bleeding Index | change in Bleeding scores (Papillary bleeding index, Muehlemann 1977) The score ranges from 0-4 and it is a continuous scale. '0' - no bleeding '1' - Single discrete bleeding point '2' - Single line of blood appears '3' - Interdental papilla fills with blood after probing '4' - profuse bleeding after probing Calculation total score /number of surfaces examined = Index score for each patient. Mean plaque score is calculated for all the patients. | baseline to 12 weeks |