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

NCT ID: NCT02008500

Last Updated: 2013-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-09-30

Brief Summary

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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

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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.

Conditions

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Dentinal Hypersensitivity

Keywords

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Dentinal Hypersensitivity Gingival Recession Visual Analogue Score

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Mouthwash Group

Group 1 (placebo mouthwash group) contained 51 individuals

Group Type PLACEBO_COMPARATOR

placebo mouthwash

Intervention Type OTHER

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

Herbal Mouthwash Group

Group 2 ( Herbal mouthwash) contained 52 individual

Group Type ACTIVE_COMPARATOR

Herbal Mouthwash

Intervention Type OTHER

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

Non Herbal Mouthwash Group

Group 3 (Non Herbal mouthwash) contained 50 individuals

Group Type SHAM_COMPARATOR

Non Herbal Mouthwash

Intervention Type OTHER

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

Interventions

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placebo mouthwash

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

Intervention Type OTHER

Herbal Mouthwash

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

Intervention Type OTHER

Non Herbal Mouthwash

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

UNKNOWN

Sponsor Role collaborator

Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role lead

Responsible Party

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Dr. A R Pradeep

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Avani R Pradeep, MDS

Role: PRINCIPAL_INVESTIGATOR

GDCRI, Bangalore, INDIA

Other Identifiers

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GDCRI/ACM/PG/PhD/2/2013-2014

Identifier Type: -

Identifier Source: org_study_id