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Efficacy of Herbal Dentifrice in Treatment of Chronic Periodontitis

Primary Purpose

Chronic Periodontitis

Status
Recruiting
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Dentifrice Paste
Sponsored by
Dr. D. Y. Patil Dental College & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1.The patient should be in good general health as determined by the Investigator/ medical expert; 2.The patient should agree not to participate in any other oral/dental product studies during the course of this study; 3.The patient should agree to delay any dental treatment until the study has been completed; 4.The patient should agree to abstain from the use of any non-study oral hygiene products; 5.The patient should exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect); 6.The patient should agree to return for all scheduled visits and follow study procedures; 7.The patient should have a minimum of 20 teeth 8.The periodontal status of the patient should be Mild to moderate periodontitis (AAP classification 1999) 9.The oral status of the patient should be as follows: 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: 1.Presence of any condition, abnormality or situation at baseline that in the opinion of the Principal Investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data 2.Pregnant females 3.Patients having history of Tobacco use 4.Patients with Sjögren's disease 5.Patients having immune deficiency diseases, i.e., HIV or AIDS 6.Patients with poorly controlled diabetes mellitus 7.Patients taking anti TNF-alpha medication for rheumatoid arthritis 8.Patients taking anti-inflammatory, analgesic, or psychotropic drugs, 9.Patients having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity; 10.Patients with a history or presence of kidney disorders, kidney stones, celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients; 11.The teeth will be excluded from study measurements if they have deep, defective, or facial restorations; have full crowns, extensive caries, cracked enamel, or are abutment teeth for fixed or removable prosthesis; 12.The teeth having endo-perio lesion.

Sites / Locations

  • Dr. D Y Patil Dental College and Hospital, Pimpri, PuneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Dentifrice containing Jasmate formulation

Dentifrice containing Biomin formulation

Dentifrice containing placebo formulation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Clinical attachment level
Change in Clinical attachment level in chronic periodontitis patients following scaling and root planing & dentifrice usage

Secondary Outcome Measures

Change in Probing pocket depth
Change in Probing pocket depth in chronic periodontitis patients following scaling and root planing & dentifrice usage
Change in Plaque Index levels
Change in Plaque index levels in chronic periodontitis patients following scaling and root planing & dentifrice usage
Change in Gingival index levels
Change in Gingival index levels in chronic periodontitis patients following scaling and root planing & dentifrice usage
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

Full Information

First Posted
September 12, 2023
Last Updated
September 12, 2023
Sponsor
Dr. D. Y. Patil Dental College & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06043687
Brief Title
Efficacy of Herbal Dentifrice in Treatment of Chronic Periodontitis
Official Title
Clinical Efficacy of Two Different Dentifrice Formulations in Treatment of Chronic Periodontitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. D. Y. Patil Dental College & Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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: To assess efficacy and safety of Jasmate toothpaste preparation over a period of 24 weeks. 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dentifrice containing Jasmate formulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Dentifrice containing Biomin formulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dentifrice containing placebo formulation
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dentifrice Paste
Intervention Description
Scaling and Root planing followed by dentifrice usage
Primary Outcome Measure Information:
Title
Change in Clinical attachment level
Description
Change in Clinical attachment level in chronic periodontitis patients following scaling and root planing & dentifrice usage
Time Frame
Baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Change in Probing pocket depth
Description
Change in Probing pocket depth in chronic periodontitis patients following scaling and root planing & dentifrice usage
Time Frame
Baseline to 24 weeks
Title
Change in Plaque Index levels
Description
Change in Plaque index levels in chronic periodontitis patients following scaling and root planing & dentifrice usage
Time Frame
Baseline to 24 weeks
Title
Change in Gingival index levels
Description
Change in Gingival index levels in chronic periodontitis patients following scaling and root planing & dentifrice usage
Time Frame
Baseline to 24 weeks
Title
Change in mean sulcus bleeding index levels
Description
Change in mean sulcus bleeding index levels in chronic periodontitis patients following scaling and root planing & dentifrice usage
Time Frame
Baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.The patient should be in good general health as determined by the Investigator/ medical expert; 2.The patient should agree not to participate in any other oral/dental product studies during the course of this study; 3.The patient should agree to delay any dental treatment until the study has been completed; 4.The patient should agree to abstain from the use of any non-study oral hygiene products; 5.The patient should exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect); 6.The patient should agree to return for all scheduled visits and follow study procedures; 7.The patient should have a minimum of 20 teeth 8.The periodontal status of the patient should be Mild to moderate periodontitis (AAP classification 1999) 9.The oral status of the patient should be as follows: 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: 1.Presence of any condition, abnormality or situation at baseline that in the opinion of the Principal Investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data 2.Pregnant females 3.Patients having history of Tobacco use 4.Patients with Sjögren's disease 5.Patients having immune deficiency diseases, i.e., HIV or AIDS 6.Patients with poorly controlled diabetes mellitus 7.Patients taking anti TNF-alpha medication for rheumatoid arthritis 8.Patients taking anti-inflammatory, analgesic, or psychotropic drugs, 9.Patients having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity; 10.Patients with a history or presence of kidney disorders, kidney stones, celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients; 11.The teeth will be excluded from study measurements if they have deep, defective, or facial restorations; have full crowns, extensive caries, cracked enamel, or are abutment teeth for fixed or removable prosthesis; 12.The teeth having endo-perio lesion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dharmarajan Gopalakrishnan, MDS, PhD
Phone
9822046667
Email
drgopalmds@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dharmarajan Gopalakrishnan, MDS, PhD
Organizational Affiliation
Dr. D Y Patil Dental College and Hospital, Pimpri, Pune
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. D Y Patil Dental College and Hospital, Pimpri, Pune
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411018
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dharmarajan Gopalakrishnan, Ph.D
Phone
9822046667
Email
drgopalmds@gmail.com
First Name & Middle Initial & Last Name & Degree
Dharmarajan Gopalakrishnan, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Herbal Dentifrice in Treatment of Chronic Periodontitis

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