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Efficacy of Herbal Dentifrice for Management of Dentinal Hypersensitivity

Primary Purpose

Dentinal Hypersensitivity, Chronic Periodontitis

Status
Recruiting
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Toothpaste Preparation
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 Dentinal Hypersensitivity

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: The patient should be in good general health as determined by the Investigator/ medical expert; The patient should agree not to participate in any other oral/dental product studies during the course of this study; The patient should agree to delay any dental treatment until the study has been completed; The patient should agree to abstain from the use of any non-study oral hygiene products; The patient should exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect); The patient should agree to return for all scheduled visits and follow study procedures; The patient should have a minimum of 20 teeth The periodontal status of the patient should be Mild to moderate periodontitis (AAP classification 1999) 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 The patient should have two teeth with a Schiff sensitivity score > 1 in response to air challenge. If these two eligible teeth are located in the same quadrant, they have to be separated by one other teeth. Exclusion Criteria: 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 Pregnant females Patients having history of Tobacco use Patients with Sjögren's disease Patients having immune deficiency diseases, i.e., HIV or AIDS Patients with poorly controlled diabetes mellitus Patients taking anti TNF-alpha medication for rheumatoid arthritis Patients taking anti-inflammatory, analgesic, or psychotropic drugs, 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; 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; 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; 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

Group A (Experimental group): (n=25): Curcumin based Jasmate toothpaste preparation

Group B (Positive Control): (n=25): Bioactive glass based BioMin F toothpaste preparation

Group C (Negative Control): (n=25): Placebo toothpaste without any active desensitizing agent

Arm Description

Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Curcumin based Jasmate 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 8 weeks for assessment of the efficacy

Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Biomin F toothpaste (Bioactive glass with Calcium, Phosphate and Fluoride) 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 8 weeks for assessment of the efficacy

Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Placebo toothpaste without any active desensitizing agent 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 8 weeks for assessment of the efficacy

Outcomes

Primary Outcome Measures

Change in dentinal hypersensitivity
Dentinal hypersensitivity score will be measured by Visual analogue scores on a scale of 0 to 10 using Air stimulus

Secondary Outcome Measures

Full Information

First Posted
April 8, 2023
Last Updated
July 13, 2023
Sponsor
Dr. D. Y. Patil Dental College & Hospital
Collaborators
Jasberry Healthcare Pvt. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05852366
Brief Title
Efficacy of Herbal Dentifrice for Management of Dentinal Hypersensitivity
Official Title
Efficacy of Herbal Dentifrice for Management of Dentinal Hypersensitivity Post Scaling and Root Planning in Chronic Periodontitis: A Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
July 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Recently, Herbal formulations have gained wide popularity in management of Dentinal hypersensitivity owing to the additive effects of active anti-inflammatory ingredients like Curcuma longa, Clove oil, Acacia arabica and Spinach leaves in addition to desensitizing ingredients like Potassium nitrate and/or Sodium fluoride. Jasmate herbal formulations which contains Potassium Nitrate along with aqua, calcium carbonate, sodium cocoyl glutamate, sorbitol 70%, glycerin, curcuma longa, arginine hydrochloride, erythritol, sodium saccharin, hydrated silica, sodium carboxymethyl cellulose, elettaria cardamomum, foeniculum vulgare, melaleuca leucadendra, eucalyptus globules, aloe barbadensis, carnosic acid, zinc oxide, hydroxyapatite, propolis, hippophae rhamnoides, syzygium aromaticum, myrtus communis, sodium benzoate and sodium fluoride7, where such formulations claim to have an anti-inflammatory action due to the active ingredient i.e. curcuma longa which further reduces the DH and have a synergistic effect. Efficacy of desensitizing preparations containing the above ingredients, in the form of Jasmate was tested in the laboratory along with BioMin F and results were encouraging with sufficient occlusion of the dentinal tubules in both the groups without statistically significant differences in the results. The biocompatibility (cytotoxicity) of Jasmate toothpaste preparation was evaluated in the laboratory by using human gingival fibroblasts at different concentrations. Different tests like cell cycle analysis, apoptosis / necrosis and MTT were done and Jasmate toothpaste preparation showed the lowest cytotoxicity as compared to BioMin F toothpaste preparation. Jasmate toothpaste preparation showed more than 92% of live cells in all concentrations. The current randomized controlled clinical trial will be conducted to evaluate safety and efficacy of Jasmate toothpaste preparation in the management of DH post scaling and root planing in patients with chronic periodontitis.
Detailed Description
Chronic periodontitis is an immuno-inflammatory disease characterized by inflammation of gingiva, formation of periodontal pocket, loss of attachment followed by alveolar bone destruction. In the presence of periodontal pocket various changes take place along the root surface (medial wall) out of which cytotoxic changes is of great importance.1 The first approach to manage the chronic periodontitis is thorough supra-gingival and sub-gingival scaling followed by root planing to achieve clean, smooth and hard root surface.2 One of the most common patient centered adverse outcome of scaling and root planing (Phase I therapy) is dentinal hypersensitivity which is of great clinical significance.3 Dentinal hypersensitivity (DH) is characterized by short, sharp pain arising from exposed dentin in response to stimuli typically thermal, evaporative, tactile, osmotic, or chemical and which cannot be ascribed to any other form of dental defect or pathology.4 DH leads to both physical and psychological issues for a patient with regards to the type of food selection, maintaining dental hygiene, and beauty aspects and also affects the quality of life.5 There are various formulations available to manage DH both in-office and at home like potassium nitrate, potassium chloride, strontium chloride, stannous fluoride, hexahydrate, and aluminum, potassium or ferric oxalates and fluorides.6 One of the common disadvantages of these commercially available formulations is the inadequate depth of penetration leading to partial relief from DH. To overcome this bioactive glass containing dentifrices (BioMin F) was introduced having stable hydroxycarbonate apatite crystal precipitaion that occludes the dentinal tubules when bioactive glass comes in contact with saliva.7 Recently, Herbal formulations have gained wide popularity in management of Dentinal hypersensitivity owing to the additive effects of active anti-inflammatory ingredients like Curcuma longa, Clove oil, Acacia arabica and Spinach leaves in addition to desensitizing ingredients like Potassium nitrate and/or Sodium fluoride. Jasmate herbal formulations which contains Potassium Nitrate along with aqua, calcium carbonate, sodium cocoyl glutamate, sorbitol 70%, glycerin, curcuma longa, arginine hydrochloride, erythritol, sodium saccharin, hydrated silica, sodium carboxymethyl cellulose, elettaria cardamomum, foeniculum vulgare, melaleuca leucadendra, eucalyptus globules, aloe barbadensis, carnosic acid, zinc oxide, hydroxyapatite, propolis, hippophae rhamnoides, syzygium aromaticum, myrtus communis, sodium benzoate and sodium fluoride7, where such formulations claim to have an anti-inflammatory action due to the active ingredient i.e. curcuma longa which further reduces the DH and have a synergistic effect. Efficacy of desensitizing preparations containing the above ingredients, in the form of Jasmate was tested in the laboratory along with BioMin F and results were encouraging with sufficient occlusion of the dentinal tubules in both the groups without statistically significant differences in the results. The biocompatibility (cytotoxicity) of Jasmate toothpaste preparation was evaluated in the laboratory by using human gingival fibroblasts at different concentrations. Different tests like cell cycle analysis, apoptosis / necrosis and MTT were done and Jasmate toothpaste preparation showed the lowest cytotoxicity as compared to BioMin F toothpaste preparation. Jasmate toothpaste preparation showed more than 92% of live cells in all concentrations. The current randomized controlled clinical trial will be conducted to evaluate safety and efficacy of Jasmate toothpaste preparation in the management of DH post scaling and root planing in patients with chronic periodontitis.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group A (Experimental group): (n=25): Curcumin based Jasmate toothpaste preparation
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 Curcumin based Jasmate 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 8 weeks for assessment of the efficacy
Arm Title
Group B (Positive Control): (n=25): Bioactive glass based BioMin F toothpaste preparation
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 F toothpaste (Bioactive glass with Calcium, Phosphate and Fluoride) 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 8 weeks for assessment of the efficacy
Arm Title
Group C (Negative Control): (n=25): Placebo toothpaste without any active desensitizing agent
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 toothpaste without any active desensitizing agent 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 8 weeks for assessment of the efficacy
Intervention Type
Drug
Intervention Name(s)
Toothpaste Preparation
Intervention Description
Dentifrice for management of dentinal hypersensitivity
Primary Outcome Measure Information:
Title
Change in dentinal hypersensitivity
Description
Dentinal hypersensitivity score will be measured by Visual analogue scores on a scale of 0 to 10 using Air stimulus
Time Frame
Baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient should be in good general health as determined by the Investigator/ medical expert; The patient should agree not to participate in any other oral/dental product studies during the course of this study; The patient should agree to delay any dental treatment until the study has been completed; The patient should agree to abstain from the use of any non-study oral hygiene products; The patient should exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect); The patient should agree to return for all scheduled visits and follow study procedures; The patient should have a minimum of 20 teeth The periodontal status of the patient should be Mild to moderate periodontitis (AAP classification 1999) 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 The patient should have two teeth with a Schiff sensitivity score > 1 in response to air challenge. If these two eligible teeth are located in the same quadrant, they have to be separated by one other teeth. Exclusion Criteria: 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 Pregnant females Patients having history of Tobacco use Patients with Sjögren's disease Patients having immune deficiency diseases, i.e., HIV or AIDS Patients with poorly controlled diabetes mellitus Patients taking anti TNF-alpha medication for rheumatoid arthritis Patients taking anti-inflammatory, analgesic, or psychotropic drugs, 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; 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; 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; The teeth having endo-perio lesion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dharamarajan Gopalakrishnan, MDS, Ph.D
Phone
02027805600
Ext
00
Email
drgopal@dpu.edu.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dharamarajan Gopalakrishnan, MDS, Ph.D
Organizational Affiliation
DEAN, Professor and HOD
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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Herbal Dentifrice for Management of Dentinal Hypersensitivity

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