Comparison Of Clinical Efficacy Of A Herbal And A Non-Herbal Mouthwash On Dentinal Hypersensitivity
Primary Purpose
Dentinal Hypersensitivity
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
placebo mouthwash
Herbal Mouthwash
Non Herbal Mouthwash
Sponsored by
About this trial
This is an interventional treatment trial for Dentinal Hypersensitivity focused on measuring Dentinal Hypersensitivity, Gingival Recession, Visual Analogue Score
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Sham Comparator
Arm Label
Placebo Mouthwash Group
Herbal Mouthwash Group
Non Herbal Mouthwash Group
Arm Description
Group 1 (placebo mouthwash group) contained 51 individuals
Group 2 ( Herbal mouthwash) contained 52 individual
Group 3 (Non Herbal mouthwash) contained 50 individuals
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02008500
First Posted
December 4, 2013
Last Updated
December 10, 2013
Sponsor
Government Dental College and Research Institute, Bangalore
Collaborators
Himalaya Drug Company Research and Development, Makali, Bangalore, India
1. Study Identification
Unique Protocol Identification Number
NCT02008500
Brief Title
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
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore
Collaborators
Himalaya Drug Company Research and Development, Makali, Bangalore, India
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentinal Hypersensitivity
Keywords
Dentinal Hypersensitivity, Gingival Recession, Visual Analogue Score
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo Mouthwash Group
Arm Type
Placebo Comparator
Arm Description
Group 1 (placebo mouthwash group) contained 51 individuals
Arm Title
Herbal Mouthwash Group
Arm Type
Active Comparator
Arm Description
Group 2 ( Herbal mouthwash) contained 52 individual
Arm Title
Non Herbal Mouthwash Group
Arm Type
Sham Comparator
Arm Description
Group 3 (Non Herbal mouthwash) contained 50 individuals
Intervention Type
Other
Intervention Name(s)
placebo mouthwash
Intervention Description
15 ml placebo mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks
Intervention Type
Other
Intervention Name(s)
Herbal Mouthwash
Intervention Description
15 ml Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks
Intervention Type
Other
Intervention Name(s)
Non Herbal Mouthwash
Intervention Description
15 ml Non Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks
Primary Outcome Measure Information:
Title
Visual Analogue Scale score for Dentinal Hypersensitivity
Description
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.
Time Frame
Change in VAS score from Baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Avani R Pradeep, MDS
Organizational Affiliation
GDCRI, Bangalore, INDIA
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Comparison Of Clinical Efficacy Of A Herbal And A Non-Herbal Mouthwash On Dentinal Hypersensitivity
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