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Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH

Primary Purpose

Hypomineralization Molar Incisor

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Use of fluoride toothpaste
Laser Therapy
Simulated Laser Therapy
Sealant application
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypomineralization Molar Incisor

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Have a permanent molar primer with MIH;
  • Present hypersensitivity equal to the highest 3 in the VAS Scale.

Exclusion Criteria:

  • Molars with caries activity (which can confuse the etiology of hypersensitivity with pulpitis);
  • Desensitizing treatment during the last 3 months;
  • Patients who use orthodontics on the first molars;
  • Patients who, during the study, present an adverse reaction or discomfort to the hypersensitivity tests or do not tolerate the procedure will also be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Control Group

    Photobiomodulation Group

    Arm Description

    Participants in this group will receive fluoride toothpaste, simulated laser therapy and sealants.

    Participants in this group will receive fluoride toothpaste, active laser therapy and sealant simulation.

    Outcomes

    Primary Outcome Measures

    Changes in pain
    Participants will use a Visual Analog Scale (VAS) to grade the pain they feel in the affected teeth. They will choose from zero (no pain) to ten (worst possible pain) according to the degree of discomfort they feel.

    Secondary Outcome Measures

    Changes in MIH record
    For the determination of MIH according to the European Academy of Paediatric Dentistry, the following criteria will be considered: Tooth affected by demarcated opacity on occlusal or vestibular face. Defects may vary in shape, size and pattern. White, beige or brownish-yellow defects may be recognized. Defects may have different sizes (less than 1 mm is not registered). Presence of hypersensitivity Teeth with atypical restorations Permanent teeth suspected of having been extracted due to MIH. Combination of characteristics above.
    Changes in the Simplified Oral Hygiene Index (Greene and Vermillion)
    Analysis of soft plaque deposit: Code 0 = no deposits or pigmentation Code 1 = deposits covering less than 1/3 or presence of pigmentation Code 2 = deposits covering more than 1/3 but less than 2/3 Code 3 = deposits covering more than 2/3 of tooth surface
    Changes in the Schiff Cold Air Sensitivity Scale (SCASS)
    The (SCASS) will be used to assess subject response to this stimulus (0=no response to the stimulus; 1=no response to the stimulus, patient considers stimulus to be painful; 2= response to stimulus, patient moves from the stimulus; 3= response to the stimulus, patient moves from the stimulus and requests immediate discontinuation of the stimulus).

    Full Information

    First Posted
    May 6, 2022
    Last Updated
    September 1, 2022
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05370417
    Brief Title
    Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH
    Official Title
    Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH in Children - Protocol for a Blinded Randomized Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2022 (Anticipated)
    Primary Completion Date
    March 20, 2023 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

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

    5. Study Description

    Brief Summary
    Photobiomodulation has been widely used as complementary treatment for dentin hypersensitivity, with reports of clinical success. However, the literature offers only one study in which photobiomodulation was used for the treatment of sensitivity in molars with molar incisor hypomineralization (MIH). The aim of the proposed study is to determine whether photobiomodulation enhances the results of treatment with glass ionomer sealant on molars with MIH that present sensitivity. Methods and analysis: The study involving 50 patients 6 to 12 years of age tha will be randomly allocated in two groups. Group 1 (control group) (n = 25): toothpaste with a concentration of fluoride, glass ionomer sealant and sham low-level laser (LLL) and Group 2 (n = 25): toothpaste with a concentration of fluoride, glass ionomer sealant and active low-level laser (LLL). The evaluations will involve MIH record, Simplified Oral Hygiene Index (OHI), Schiff Cold Air Sensitivity Scale (SCASS) and Visual analog scale (VAS) before the procedure. Immediately after the procedure hypersensitivity index (SCASS/VAS) will be register. Record of OHI and SCASS/VAS will be register 48 horas after and as well as 01 month after the procedure. It is expected that by the second consultation a decrease in sensitivity will be observed due to the treatments received in the two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypomineralization Molar Incisor

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    The application of low-intensity laser will be simulated in one of the groups, to maintain the study blind.
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Placebo Comparator
    Arm Description
    Participants in this group will receive fluoride toothpaste, simulated laser therapy and sealants.
    Arm Title
    Photobiomodulation Group
    Arm Type
    Active Comparator
    Arm Description
    Participants in this group will receive fluoride toothpaste, active laser therapy and sealant simulation.
    Intervention Type
    Other
    Intervention Name(s)
    Use of fluoride toothpaste
    Intervention Description
    All participants will receive brushing instruction and will be provided with toothpaste with a concentration equal to or greater than 1000ppm of fluoride, indicating three daily brushings. With this generalized measure, all of them receive basic treatment for hypersensitivity.
    Intervention Type
    Radiation
    Intervention Name(s)
    Laser Therapy
    Intervention Description
    For laser application, the following dosimetric parameters will be used: Low level laser diode (infra red) wavelength 808nm with a power of 100mW. Applied in three perpendicular points and in contact with the surface. One in the vestibular, mesial and distal cervical third and the third in the center of the lesion. (6) Applied 10 seconds per point with an energy of 1 J.
    Intervention Type
    Procedure
    Intervention Name(s)
    Simulated Laser Therapy
    Intervention Description
    The same application described in the laser therapy group will be simulated, with the device turned off.
    Intervention Type
    Procedure
    Intervention Name(s)
    Sealant application
    Intervention Description
    A glass ionomer sealant will be applied to the occlusal surface of the first permanent molar.
    Primary Outcome Measure Information:
    Title
    Changes in pain
    Description
    Participants will use a Visual Analog Scale (VAS) to grade the pain they feel in the affected teeth. They will choose from zero (no pain) to ten (worst possible pain) according to the degree of discomfort they feel.
    Time Frame
    Baseline, 48 hours after the procedures and 1 month after.
    Secondary Outcome Measure Information:
    Title
    Changes in MIH record
    Description
    For the determination of MIH according to the European Academy of Paediatric Dentistry, the following criteria will be considered: Tooth affected by demarcated opacity on occlusal or vestibular face. Defects may vary in shape, size and pattern. White, beige or brownish-yellow defects may be recognized. Defects may have different sizes (less than 1 mm is not registered). Presence of hypersensitivity Teeth with atypical restorations Permanent teeth suspected of having been extracted due to MIH. Combination of characteristics above.
    Time Frame
    Baseline, 48 hours after the procedures and 1 month after.
    Title
    Changes in the Simplified Oral Hygiene Index (Greene and Vermillion)
    Description
    Analysis of soft plaque deposit: Code 0 = no deposits or pigmentation Code 1 = deposits covering less than 1/3 or presence of pigmentation Code 2 = deposits covering more than 1/3 but less than 2/3 Code 3 = deposits covering more than 2/3 of tooth surface
    Time Frame
    Baseline, 48 hours after the procedures and 1 month after.
    Title
    Changes in the Schiff Cold Air Sensitivity Scale (SCASS)
    Description
    The (SCASS) will be used to assess subject response to this stimulus (0=no response to the stimulus; 1=no response to the stimulus, patient considers stimulus to be painful; 2= response to stimulus, patient moves from the stimulus; 3= response to the stimulus, patient moves from the stimulus and requests immediate discontinuation of the stimulus).
    Time Frame
    Baseline, 48 hours after the procedures and 1 month after.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Have a permanent molar primer with MIH; Present hypersensitivity equal to the highest 3 in the VAS Scale. Exclusion Criteria: Molars with caries activity (which can confuse the etiology of hypersensitivity with pulpitis); Desensitizing treatment during the last 3 months; Patients who use orthodontics on the first molars; Patients who, during the study, present an adverse reaction or discomfort to the hypersensitivity tests or do not tolerate the procedure will also be excluded.

    12. IPD Sharing Statement

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    Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH

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