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| Name | Class |
|---|---|
| Jasberry Healthcare Pvt. Ltd | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dentifrice containing Jasmate formulation | Experimental | 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. |
|
| Dentifrice containing Biomin formulation | Active Comparator | 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. |
|
| Dentifrice containing placebo formulation | Placebo Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dentifrice Paste | Drug | Scaling and Root planing followed by dentifrice usage |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Clinical attachment level | Change in Clinical attachment level in chronic periodontitis patients following scaling and root planing & dentifrice usage | Baseline to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Probing pocket depth | Change in Probing pocket depth in chronic periodontitis patients following scaling and root planing & dentifrice usage | Baseline to 24 weeks |
| Change in Plaque Index levels |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Dharmarajan Gopalakrishnan, MDS, PhD | Dr. D Y Patil Dental College and Hospital, Pimpri, Pune | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. D Y Patil Dental College and Hospital, Pimpri, Pune | Pune | Maharashtra | 411018 | India |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Change in Plaque index levels in chronic periodontitis patients following scaling and root planing & dentifrice usage
| 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 | 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 | Baseline to 24 weeks |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |