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Treatment of Hypersensitivity Using Diode Laser and Desensitising Agent on Fluorosed and Non-fluorosed Teeth

Primary Purpose

Fluorosis, Dental, Non-Fluoride Enamel Opacities, Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fluorosed Group
Non Flourosed Group
Sponsored by
Krishnadevaraya College of Dental Sciences & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fluorosis, Dental

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Patients with a positive response for hypersensitivity testing (Pashley, 1990) i.e. cold water testing using ice cold water (Trowbridge et al., 1980),

    • Air blow test (Coleman and Kinderknecht, 2000),
    • Electric tactile stimulation test (Camps and Pashley, 2003),
    • Patients presenting with non-carious cervical lesions in the enamel (Loomba et al., 2013), fluorosed teeth wherein fluorotic enamel staining confirmed by clinical examination, healthy non fluorosed teeth, which was confirmed by clinical examination (Dean, 1934).

Exclusion Criteria:

  • The following were set as the exclusion criteria;

    • Patients undergoing any form of restorative endodontic,
    • Orthodontic treatment or crown restorations,
    • Local defects including caries and fractures,
    • Presence of any systemic diseases,
    • Acute pain conditions (like apical periodontitis, periapical abscess),
    • Presence of periodontal disease or a history of periodontal treatment in last 6 months,
    • Usage of desensitising toothpaste or mouth rinse in the last 4 weeks,
    • Patients allergic to ingredients used in the study product,
    • Teeth with intrinsic stains caused by other reasons.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Fluorosed Group

    Non Flourosed Group

    Arm Description

    45 patients for the fluorosis groupGROUP 1A: Patients with healthy fluorosed teeth receiving desensitising agent (potassium nitrate- RA Themoseal**) treatment. (n=15) GROUP 1B: Patients with healthy fluorosed teeth receiving diode laser treatment$. (n=15) GROUP 1C: Patients with healthy fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA Thermoseal**) treatment. (n=15)

    45 patients for the non-fluorosis groupGROUP 2- Non Flourosed Group (n=45) GROUP 2A: Patients with healthy non fluorosed teeth receiving desensitising agent (potassium nitrate- RA Thermoseal**) treatment. (n=15) GROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal**) treatment. (n=15

    Outcomes

    Primary Outcome Measures

    Reduction in hypersensitivity
    The primary outcome that was assessed in the study was the reduction in dentinal hypersensitivity sensation. The visual analogue scale was used as a recording scale when tested with the tests for hypersensitivity, which were the testing with a blast of air, ice cold water testing and electrical tactile sensitivity testing using a scratch-o-meter.

    Secondary Outcome Measures

    use of diode laser in reducing hypersensitivity
    Efficacy of treatment when diode laser is used alone as a treatment option after scaling and root planing.
    use of desensitising agent alone
    Efficacy of treatment when desensitising agent was used as monotherapy after scaling and root planing
    combination of densensitising agent and diode laser
    3. Efficacy of treatment when a combination of diode laser and desensitising agent was used after scaling and root planing, for the treatment of dentinal hypersensitivity.

    Full Information

    First Posted
    July 26, 2017
    Last Updated
    August 7, 2017
    Sponsor
    Krishnadevaraya College of Dental Sciences & Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03237793
    Brief Title
    Treatment of Hypersensitivity Using Diode Laser and Desensitising Agent on Fluorosed and Non-fluorosed Teeth
    Official Title
    Treatment of Hypersensitivity Using Diode Laser and Potassium Nitrate Desensitising Agent- a Comparison of Treatment Effects on Fluorosed and Non-fluorosed Teeth- an in Vivo Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2014 (Actual)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    September 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Krishnadevaraya College of Dental Sciences & Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The present study was designed as a randomised controlled clinical trial which was unicenter, double-blinded, parallel designed study, according to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010. The study period was from July 2014 to September 2015.
    Detailed Description
    90 Patients visiting the Out Patient of Department of Periodontology, Krishnadevaraya College of Dental Sciences and Hospital, Bengaluru, India, presenting with a chief complaint of dentinal hypersensitivity were enrolled in the study. Patients' age ranged from 18-60 years. The subjects interested in participating were explained in detail the treatment protocol. A verbal consent as well as a written informed consent was obtained from each patient Treatment of dentinal hypersensitivity with a combination of diode laser and potassium nitrate desensitising agent was considered as the test group and this was compared with diode lasers alone and desensitising agent alone as the positive control groups. The study was conducted in full accordance with the declared ethical principles (World Medical Association Declaration of Helsinki, version VII, 2013)13 and was approved by the Institutional review board of Krishnadevaraya College of Dental Science and Hospital, under the registration number of (ACA/DCD/SYN/KCODS - B/PG/2013-2014).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fluorosis, Dental, Non-Fluoride Enamel Opacities, Dentin Sensitivity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The present study was designed as a randomised controlled clinical trial which was unicenter, double-blinded, parallel designed study, according to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    A unified stratified randomization, double blind controlled parallel designed was the type generated the allocation sequence. A skilled assistant enrolled the participants and assigned the participants to interventions.
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fluorosed Group
    Arm Type
    Active Comparator
    Arm Description
    45 patients for the fluorosis groupGROUP 1A: Patients with healthy fluorosed teeth receiving desensitising agent (potassium nitrate- RA Themoseal**) treatment. (n=15) GROUP 1B: Patients with healthy fluorosed teeth receiving diode laser treatment$. (n=15) GROUP 1C: Patients with healthy fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA Thermoseal**) treatment. (n=15)
    Arm Title
    Non Flourosed Group
    Arm Type
    Placebo Comparator
    Arm Description
    45 patients for the non-fluorosis groupGROUP 2- Non Flourosed Group (n=45) GROUP 2A: Patients with healthy non fluorosed teeth receiving desensitising agent (potassium nitrate- RA Thermoseal**) treatment. (n=15) GROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal**) treatment. (n=15
    Intervention Type
    Procedure
    Intervention Name(s)
    Fluorosed Group
    Intervention Description
    A single episode of laser therapy with without potassium nitrate (RA Thermoseal*) desensitising agent application was administered to the patients, A group only with desensitising paste and A group with desensitising paste and laser treatment depending on the study group they were assigned
    Intervention Type
    Procedure
    Intervention Name(s)
    Non Flourosed Group
    Intervention Description
    A single episode of laser† therapy with or without potassium nitrate (RA Thermoseal*) desensitising agent application was administered to the patients, depending on the study group they were assignedGROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment$. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal**) treatment.
    Primary Outcome Measure Information:
    Title
    Reduction in hypersensitivity
    Description
    The primary outcome that was assessed in the study was the reduction in dentinal hypersensitivity sensation. The visual analogue scale was used as a recording scale when tested with the tests for hypersensitivity, which were the testing with a blast of air, ice cold water testing and electrical tactile sensitivity testing using a scratch-o-meter.
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    use of diode laser in reducing hypersensitivity
    Description
    Efficacy of treatment when diode laser is used alone as a treatment option after scaling and root planing.
    Time Frame
    30 mins
    Title
    use of desensitising agent alone
    Description
    Efficacy of treatment when desensitising agent was used as monotherapy after scaling and root planing
    Time Frame
    30 minutes
    Title
    combination of densensitising agent and diode laser
    Description
    3. Efficacy of treatment when a combination of diode laser and desensitising agent was used after scaling and root planing, for the treatment of dentinal hypersensitivity.
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Patients with a positive response for hypersensitivity testing (Pashley, 1990) i.e. cold water testing using ice cold water (Trowbridge et al., 1980), Air blow test (Coleman and Kinderknecht, 2000), Electric tactile stimulation test (Camps and Pashley, 2003), Patients presenting with non-carious cervical lesions in the enamel (Loomba et al., 2013), fluorosed teeth wherein fluorotic enamel staining confirmed by clinical examination, healthy non fluorosed teeth, which was confirmed by clinical examination (Dean, 1934). Exclusion Criteria: The following were set as the exclusion criteria; Patients undergoing any form of restorative endodontic, Orthodontic treatment or crown restorations, Local defects including caries and fractures, Presence of any systemic diseases, Acute pain conditions (like apical periodontitis, periapical abscess), Presence of periodontal disease or a history of periodontal treatment in last 6 months, Usage of desensitising toothpaste or mouth rinse in the last 4 weeks, Patients allergic to ingredients used in the study product, Teeth with intrinsic stains caused by other reasons.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rashmi Paramashivaiah, MDS
    Organizational Affiliation
    Krishnadevaraya college of dental sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of Hypersensitivity Using Diode Laser and Desensitising Agent on Fluorosed and Non-fluorosed Teeth

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