CompletedPhase 3

Efficacy of Herbal Dentifrice for Management of Dentinal Hypersensitivity

India75 participantsStarted 2023-05-15

Plain-language 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.

Who can participate

Age range

25 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Pat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in dentinal hypersensitivity

Timeframe: Baseline to 8 weeks

Trial details

NCT IDNCT05852366

SponsorDr. D. Y. Patil Dental College & Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-15

View on ClinicalTrials.gov More Dentinal Hypersensitivity trials