NCT06043687

Efficacy of Herbal Dentifrice in Treatment of Chronic Periodontitis

Clinical Efficacy of Two Different Dentifrice Formulations in Treatment of Chronic Periodontitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Dr. D. Y. Patil Dental College & Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. To assess efficacy and safety of Jasmate toothpaste preparation over a period of 24 weeks. 2. To evaluate the change in PI, GI, mSBI, PPD, CAL, in chronic periodontitis patients following scaling and root planing at 4 weeks, 8 weeks, 12 weeks and 24 weeks compared to baseline using Jasmate toothpaste preparation. 3. To evaluate the change in PI, GI, mSBI, PPD, CAL, in chronic periodontitis patients following scaling and root planing at 4 weeks, 8 weeks, 12 weeks and 24 weeks compared to baseline using BioMin Ftoothpaste preparation. 4. To compare the change in PI, GI, mSBI, PPD, CAL in chronic periodontitis patients following scaling and root planing at 4 weeks, 8 weeks, 12 weeks and 24 weeks using Jasmate toothpaste preparation and BioMin Ftoothpaste preparation.

Conditions

• Chronic Periodontitis

Interventions

Type	Name	Description
DRUG	Dentifrice Paste	Scaling and Root planing followed by dentifrice usage

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-10-15
• Completion: 2023-12-15
• First posted: 2023-09-21
• Last updated: 2024-10-08

Locations

1 site across 1 country: India