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

NCT02008500 | Completed Phase 2 DMC

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2013-2014
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dentinal Hypersensitivity

Keywords

Dentinal Hypersensitivity; Gingival Recession; Visual Analogue Score

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Placebo Mouthwash Group

PLACEBO COMPARATOR

Group 1 (placebo mouthwash group) contained 51 individuals

Other: placebo mouthwash

Herbal Mouthwash Group

ACTIVE COMPARATOR

Group 2 ( Herbal mouthwash) contained 52 individual

Other: Herbal Mouthwash

Non Herbal Mouthwash Group

SHAM COMPARATOR

Group 3 (Non Herbal mouthwash) contained 50 individuals

Other: Non Herbal Mouthwash

Interventions

placebo mouthwash OTHER

15 ml placebo mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks

Placebo Mouthwash Group

Herbal Mouthwash OTHER

15 ml Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks

Herbal Mouthwash Group

Non Herbal Mouthwash OTHER

15 ml Non Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks

Non Herbal Mouthwash Group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Avani R Pradeep, MDS

  GDCRI, Bangalore, INDIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 11, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 11, 2013

Record last verified: 2013-12