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

• ClinicalTrials.gov Identifier: NCT02008500
• Recruitment Status: Completed
• First Posted: December 11, 2013
• Last Update Posted: December 11, 2013
• Sponsor: Government Dental College and Research Institute, Bangalore
• Collaborator: Himalaya Drug Company Research and Development, Makali, Bangalore, India
• Information provided by (Responsible Party): Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Dentinal Hypersensitivity	Other: placebo mouthwash; Other: Herbal Mouthwash; Other: Non Herbal Mouthwash	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: COMPARISON OF CLINICAL EFFICACY OF A HERBAL AND A NON HERBAL MOUTHWASH ON DENTINAL HYPERSENSITIVITY: A TRIPLE MASKED RANDOMIZED CONTROLLED CLINICAL TRIAL
• Study Start Date: July 2013
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Visual Analogue Scale score for Dentinal Hypersensitivity [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Government Dental College and Research Institute, Bangalore

Himalaya Drug Company Research and Development, Makali, Bangalore, India

Investigators

• Principal Investigator: Avani R Pradeep, MDS; GDCRI, Bangalore, INDIA

More Information

• Responsible Party: Dr. A R Pradeep, Professor, Government Dental College and Research Institute, Bangalore
• ClinicalTrials.gov Identifier: NCT02008500
• Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2013-2014
• First Posted: December 11, 2013
• Last Update Posted: December 11, 2013
• Last Verified: December 2013

Keywords provided by Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore:

Dentinal Hypersensitivity; Gingival Recession; Visual Analogue Score

Additional relevant MeSH terms:

Hypersensitivity; Immune System Diseases