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

Government Dental College and Research Institute, Bangalore

Status and phase: Completed; Phase 2

Conditions: Dentinal Hypersensitivity

Treatments: Other: Herbal Mouthwash; Other: Non Herbal Mouthwash; Other: placebo mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT02008500

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups, including a placebo group

Placebo Mouthwash Group

Placebo Comparator group

Description:

Group 1 (placebo mouthwash group) contained 51 individuals

Treatment:

Other: placebo mouthwash

Herbal Mouthwash Group

Active Comparator group

Description:

Group 2 ( Herbal mouthwash) contained 52 individual

Treatment:

Other: Herbal Mouthwash

Non Herbal Mouthwash Group

Sham Comparator group

Description:

Group 3 (Non Herbal mouthwash) contained 50 individuals

Treatment:

Other: Non Herbal Mouthwash