Efficacy of Herbal Dentifrice for Management of Dentinal Hypersensitivity

NCT05852366 | Completed Phase 3

• 1 other identifier: DYPV/EC/883/22
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 which further reduces the DH.
• 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.

Conditions

Dentinal Hypersensitivity; Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• Change in dentinal hypersensitivity

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

  Baseline to 8 weeks

Study Arms (3)

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

EXPERIMENTAL

Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the 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

Drug: Toothpaste Preparation

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

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 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

Drug: Toothpaste Preparation

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

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 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

Drug: Toothpaste Preparation

Interventions

Toothpaste Preparation DRUG

Dentifrice for management of dentinal hypersensitivity

Group A (Experimental group): (n=25): 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

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. D. Y. Patil Dental College & Hospital: lead
• Jasberry Healthcare Pvt. Ltd: collaborator

Study Sites (1)

Dr. D Y Patil dental College and Hospital, Pimpri, Pune

Pune, Maharashtra, 411018, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dharamarajan Gopalakrishnan, MDS, Ph.D

  DEAN, Professor and HOD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DEAN, Professor and HOD

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: May 10, 2023
• Study Start: May 15, 2023
• Primary Completion: July 15, 2023
• Study Completion: December 15, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)