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Completed

NCT Number: NCT02008500

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

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.

Completed

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Key information

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo Mouthwash

Other

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

Herbal Mouthwash

Other

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

Non Herbal Mouthwash

Other

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 11, 2013
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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