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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
Government Dental College and Research Institute, Bangalore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentinal Hypersensitivity focused on measuring Dentinal Hypersensitivity, Gingival Recession, Visual Analogue Score

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts 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.

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

    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
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    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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