NCT05852366

Efficacy of Herbal Dentifrice for Management of Dentinal Hypersensitivity

Efficacy of Herbal Dentifrice for Management of Dentinal Hypersensitivity Post Scaling and Root Planning in Chronic Periodontitis: A Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Dr. D. Y. Patil Dental College & Hospital · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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 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

Type	Name	Description
DRUG	Toothpaste Preparation	Dentifrice for management of dentinal hypersensitivity

Timeline

• Start date: 2023-05-15
• Primary completion: 2023-07-15
• Completion: 2023-12-15
• First posted: 2023-05-10
• Last updated: 2024-10-08

Locations

1 site across 1 country: India