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Efficacy of Herbal Dentifrice for Management of Dentinal Hypersensitivity

NCT05852366 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-10-08

No results posted yet for this study

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

Interventions

DRUG

Toothpaste Preparation

Dentifrice for management of dentinal hypersensitivity

Sponsors & Collaborators

  • Jasberry Healthcare Pvt. Ltd

    collaborator UNKNOWN

  • Dr. D. Y. Patil Dental College & Hospital

    lead OTHER

Principal Investigators

  • Dharamarajan Gopalakrishnan, MDS, Ph.D · DEAN, Professor and HOD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-15
Primary Completion
2023-07-15
Completion
2023-12-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05852366 on ClinicalTrials.gov