Clinical trial NCT02008500: Comparison Of Clinical Efficacy Of A Herbal And A Non-Herbal Mouthwash On Dentinal Hypersensitivity
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dentinal Hypersensitivity
Keywords: Dentinal Hypersensitivity
Gingival Recession
Visual Analogue Score
Lead sponsor: Government Dental College and Research Institute, Bangalore
Sponsor class: OTHER
Collaborators: name: Himalaya Drug Company Research and Development, Makali, Bangalore, India
First posted: 2013-12-11
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Visual Analogue Scale score for Dentinal Hypersensitivity
timeFrame: Change in VAS score from Baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GDCRI, Bangalore, INDIA
name: Avani R Pradeep, MDS
role: PRINCIPAL_INVESTIGATOR
References: