A Phase 3 interventional study of Dentifrice Paste in Chronic Periodontitis, sponsored by Dr. D. Y. Patil Dental College & Hospital. Completed at 1 site in India. Open to participants aged 30 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Dr. D. Y. Patil Dental College & Hospital · Phase 3, Interventional, and Treatment
The study will be a single center, longitudinal prospective, triple blind (investigators, patients and statistician), randomized design. After informed consent, a target population of about 75 healthy adult volunteers with periodontitis will be included in the study. Patients will be randomized and categorized into three experimental groups each containing 25 patients. The randomization process will be carried out by use of sequentially numbered opaque sealed envelopes (SNOSE method).The recording of all the soft tissues data plaque index, gingival index, the modified sulcus bleeding index and the periodontal probing depth and clinical attachment level will be carried out at baseline, 4 weeks, 8 weeks, 12 weeks and will be maintained till 24 weeks for efficacy and safety evaluation.
Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 24 weeks for assessment of the efficacy and safety in periodontitis patients.
A complete and detail oral examination will then be conducted to evaluate the oral and perioral region, including soft tissues. Patients will return at study location at 4 weeks, 8 weeks, 12 weeks and 24 weeks for the soft-tissue assessment using the plaque index, gingival index, the modified sulcus bleeding index and the periodontal probing depth and clinical attachment level.
The following objectives will be assessed -
Objectives:
386 studies on the registry are indexed under Chronic Periodontitis; 23 are open to participants now.
This study's enrollment of 75 is above the median of 46 across 314 interventional studies indexed under Chronic Periodontitis.
Browse Chronic Periodontitis studies →Dr. D. Y. Patil Dental College & Hospital is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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Plaque index (Silness \& Löe 1964)>2 Gingival Index (Löe and Silness 1963) >1.5 Modified Sulcus Bleeding Index (Mombelli et al 1987) >1 PPD > 4mm
Exclusion Criteria:
Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Jasmate formulation toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 24 weeks for assessment of the efficacy and safety in periodontitis patients.
Drug: Dentifrice Paste
Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Biomin formulation toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 24 weeks for assessment of the efficacy and safety in periodontitis patients.
Drug: Dentifrice Paste
Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Placebo formulation toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 24 weeks for assessment of the efficacy and safety in periodontitis patients.
Drug: Dentifrice Paste
Scaling and Root planing followed by dentifrice usage
Change in Clinical attachment level
Change in Clinical attachment level in chronic periodontitis patients following scaling and root planing \& dentifrice usage
Time frame: Baseline to 24 weeks
Change in Probing pocket depth
Change in Probing pocket depth in chronic periodontitis patients following scaling and root planing \& dentifrice usage
Time frame: Baseline to 24 weeks
Change in Plaque Index levels
Change in Plaque index levels in chronic periodontitis patients following scaling and root planing \& dentifrice usage
Time frame: Baseline to 24 weeks
Change in Gingival index levels
Change in Gingival index levels in chronic periodontitis patients following scaling and root planing \& dentifrice usage
Time frame: Baseline to 24 weeks
Change in mean sulcus bleeding index levels
Change in mean sulcus bleeding index levels in chronic periodontitis patients following scaling and root planing \& dentifrice usage
Time frame: Baseline to 24 weeks
Plan to share: No
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Ran from Aug 2023 to primary completion in Oct 2023, 2 months.
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Dr. D. Y. Patil Dental College & Hospital