A Phase 4 interventional study of Minocycline Hydrochloride in Periodontitis, Adult, sponsored by Mahsa University. Completed at 1 site in Malaysia. Open to participants aged 25 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-23.
Sponsored by Mahsa University · Phase 4, Interventional, and Treatment
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Mahsa University is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Minocycline gel
Drug: Minocycline Hydrochloride
Similar gel without the active agent
Drug: Minocycline Hydrochloride
Administration of Periocline gel into the periodontal pockets will be carried out until it overflows the pockets
Also known as: Periocline
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.
Time frame: 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
Time frame: baseline to 12 weeks
Clinical Attachment Levels (CAL)
change in CAL
Time frame: baseline, 6 weeks and 12 weeks
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.
Time frame: 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.
Time frame: baseline to 12 weeks
Plan to share: No
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Mahsa University