Comparison Of Clinical Efficacy Of A Herbal And A Non-Herbal Mouthwash On Dentinal Hypersensitivity

Phase 2

Completed

• Conditions: Dentinal Hypersensitivity
• Interventions: Other: placebo mouthwash; Other: Herbal Mouthwash; Other: Non Herbal Mouthwash

• Registration Number: NCT02008500
• Lead Sponsor: Government Dental College and Research Institute, Bangalore

Brief Summary

Aim of this study was to assess and compare the efficacy of a commercially available novel herbal mouthwash containing potassium nitrate on Dentinal Hypersensitivity (DH) compared to a placebo and non herbal potassium nitrate over a period of 12 weeks.

Detailed Description

A total of 120 subjects were divided into 3 groups randomly. Group 1 was given the placebo mouthwash, Group 2 was given the herbal mouthwash ( Hiora K, which contains potassium nitrate derived from Suryakshara plant) and Group 3 was given the non herbal mouthwash (Containing non herbal potassium nitrate). Sensitivity scores (VAS score) were recorded at baseline, 3 weeks, 6 weeks and 12 weeks.

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2013-12
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-10
• Last Update Submitted: 2013-12-10
• Study First Posted: 2013-12-11
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Subjects with a history of DH caused by gingival recession or cervical erosion were selected at baseline. Subjects with a minimum 20 natural permanent teeth and at least two teeth with a VAS score of ≥4 were included in the study.

Exclusion Criteria

• of teeth with caries, defective restorations, chipped teeth and deep periodontal pockets (probing depth >4 mm). Also, the subjects who had undergone periodontal surgery within the previous six months, and those with orthodontic appliances or bridge work that would interfere with evaluation were excluded. Subjects with the presence of occlusal overload or occlusal adjustment recently made in the tooth to be studied were also excluded. Subjects who had undertaken treatment with any product that could influence the DH of the patient in the 30 days prior to baseline were excluded. Also, the subjects with allergy to the ingredients used in the study or exhibiting any gross oral pathology, eating disorders, chronic disease, pregnancy and lactation, acute myocardial infarction within the past six months, uncontrolled metabolic disease, major psychiatric disorder, heavy smoking or alcohol abuse, any systemic disease or any disease requiring repeated or regular analgesia, anti-inflammatory drugs, or antihistamines were excluded from the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Mouthwash Group	placebo mouthwash	Group 1 (placebo mouthwash group) contained 51 individuals
Herbal Mouthwash Group	Herbal Mouthwash	Group 2 ( Herbal mouthwash) contained 52 individual
Non Herbal Mouthwash Group	Non Herbal Mouthwash	Group 3 (Non Herbal mouthwash) contained 50 individuals

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale score for Dentinal Hypersensitivity	Change in VAS score from Baseline to 12 weeks	Based on a 10-cm VAS score which was used to measure tooth sensitivity, a pain-free response was allotted a score of zero whereas a score of 10 was given to subjects with excruciating pain or discomfort.