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

COMPARISON OF CLINICAL EFFICACY OF A HERBAL AND A NON HERBAL MOUTHWASH ON DENTINAL HYPERSENSITIVITY: A TRIPLE MASKED RANDOMIZED CONTROLLED CLINICAL TRIAL

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.

Study Overview

• Status: Completed
• Conditions: Dentinal Hypersensitivity
• Intervention / Treatment: Other: placebo mouthwash; Other: Herbal Mouthwash; Other: Non Herbal Mouthwash

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Mouthwash Group; Group 1 (placebo mouthwash group) contained 51 individuals	Other: placebo mouthwash; 15 ml placebo mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks
Active Comparator: Herbal Mouthwash Group; Group 2 ( Herbal mouthwash) contained 52 individual	Other: Herbal Mouthwash; 15 ml Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks
Sham Comparator: Non Herbal Mouthwash Group; Group 3 (Non Herbal mouthwash) contained 50 individuals	Other: Non Herbal Mouthwash; 15 ml Non Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale score for Dentinal Hypersensitivity	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.	Change in VAS score from Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Government Dental College and Research Institute, Bangalore
• Collaborators: Himalaya Drug Company Research and Development, Makali, Bangalore, India

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Gingival Recession; Dentinal Hypersensitivity; Visual Analogue Score
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014