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Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization

Primary Purpose

Dentin Sensitivity, Molar Incisor Hypomineralization

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Hygiene Instructions
Sealant application
Low-level Laser
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 18 and 35 years;
  • Good overall health;
  • At least one tooth with MIH and DH reported in the cervical region with sensitivity equal to or greater than 4 on the VAS.

Exclusion Criteria:

  • Active caries or defective restorations on the tooth to be analyzed;
  • Sufficient dentin loss that requires restorative treatment or periodontal surgery;
  • Having undergone any professional desensitizing treatment in the previous six months;
  • Having used a desensitizing paste in the previous three months;
  • Use of anti-inflammatory drugs or analgesics at the time of recruitment;
  • Currently pregnant or nursing.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Control Group

    Sealant Group

    Low-Level Laser Group

    Low Level Laser + Sealant Group

    Arm Description

    The volunteers in this group will receive the same hygiene instructions as the other groups and will undergo both treatments, except that water will be used instead of the sealant and the laser device will be set to a power of 0 W. In other words, the same irradiation procedure will be performed but without the emission of light.

    The volunteers in this group will receive treatment with sealant (Permaseal - Ultradent), which is a photopolymerizable methacrylate-based resin.

    The volunteers in this group will receive irradiation with AsGaAl laser at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil) with relative isolation.

    The volunteers in this group will receive the same irradiation administered to Low-level Laser Group. During the last session, these volunteers will also receive the same sealant applied in Sealant Group.

    Outcomes

    Primary Outcome Measures

    Change in pain evaluated through a Visual Analog Scale (VAS)
    The researcher will assess the sensitive tooth using cold air from the triple syringe (2 s of compressed air at a pressure of approximately 40 psi with the syringe perpendicular to the tooth surface at a distance of approximately 0.5 cm). Neighboring teeth will be protected with cotton rolls or the examiner's fingers9. The volunteer will then indicate a whole number between 0 (absence of pain) to 10 (worst pain possible) on the 10-cm VAS scale that best describes his/her perception of pain.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2020
    Last Updated
    November 25, 2020
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04407702
    Brief Title
    Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization
    Official Title
    Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization: Study Protocol for a Randomized, Controlled, Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    August 30, 2021 (Anticipated)
    Study Completion Date
    December 10, 2021 (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
    Background: Dentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: 1) the dentin must be exposed and 2) the dentinal tubules must be open and connected to the pulp. Molar-incisor hypomineralization (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH. Objective: The aim of the proposed randomized, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH. Methods: One hundred forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with Permaseal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL) (AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil). In Group 4, sensitive teeth will be treated with both LLL and Permaseal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated one week, one month, three months and six months after the treatments. Discussion: This study will enable the determination of differences in the effectiveness of the proposed treatments as well as differences among the evaluation times for each proposed treatment.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    All volunteers and the evaluator of the degree of sensitivity will be blinded to the allocation. The researcher in charge of applying the products will not be blinded due to the different forms of clinical manipulation of the products.
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    Experimental
    Arm Description
    The volunteers in this group will receive the same hygiene instructions as the other groups and will undergo both treatments, except that water will be used instead of the sealant and the laser device will be set to a power of 0 W. In other words, the same irradiation procedure will be performed but without the emission of light.
    Arm Title
    Sealant Group
    Arm Type
    Experimental
    Arm Description
    The volunteers in this group will receive treatment with sealant (Permaseal - Ultradent), which is a photopolymerizable methacrylate-based resin.
    Arm Title
    Low-Level Laser Group
    Arm Type
    Experimental
    Arm Description
    The volunteers in this group will receive irradiation with AsGaAl laser at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil) with relative isolation.
    Arm Title
    Low Level Laser + Sealant Group
    Arm Type
    Experimental
    Arm Description
    The volunteers in this group will receive the same irradiation administered to Low-level Laser Group. During the last session, these volunteers will also receive the same sealant applied in Sealant Group.
    Intervention Type
    Other
    Intervention Name(s)
    Hygiene Instructions
    Intervention Description
    Two weeks prior to the onset of the study, the volunteers will undergo a wash-out period, in which they will only use oral hygiene products donated by the researchers. These products will be used through to the end of the study. The oral hygiene kit will contain a soft-bristle toothbrush (Professional Lab Series, Colgate Palmolive), fluoride toothpaste with no desensitizing agent (Elmex) and dental floss (Colgate). The participants will be extensively trained with regards to all procedures involved in the experiment.
    Intervention Type
    Procedure
    Intervention Name(s)
    Sealant application
    Intervention Description
    The teeth to be sealed will be isolated and 35% phosphoric acid will be applied for 20 seconds, followed by rinsing and drying the dental surfaces. A thin layer of PermaSeal will be applied to the tooth surface for 5 seconds and photopolymerized for 20 seconds. The occlusion will then be evaluated.
    Intervention Type
    Radiation
    Intervention Name(s)
    Low-level Laser
    Intervention Description
    Irradiation with AsGaAl laser at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil) with relative isolation. The power will be set to 100 mW; energy density will be 35 J/cm2 (considering a spot size of 0.028 cm2 of the equipment) and the dose will be 1 J per point. Irradiation will be performed on a cervical point, an apical point and a point precisely over the lesion, totaling a dose of 3 J. Treatment will be performed in three sessions with a 72-hour interval between sessions.
    Primary Outcome Measure Information:
    Title
    Change in pain evaluated through a Visual Analog Scale (VAS)
    Description
    The researcher will assess the sensitive tooth using cold air from the triple syringe (2 s of compressed air at a pressure of approximately 40 psi with the syringe perpendicular to the tooth surface at a distance of approximately 0.5 cm). Neighboring teeth will be protected with cotton rolls or the examiner's fingers9. The volunteer will then indicate a whole number between 0 (absence of pain) to 10 (worst pain possible) on the 10-cm VAS scale that best describes his/her perception of pain.
    Time Frame
    Baseline, one week, one month, three months and six months after the final treatment session.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age between 18 and 35 years; Good overall health; At least one tooth with MIH and DH reported in the cervical region with sensitivity equal to or greater than 4 on the VAS. Exclusion Criteria: Active caries or defective restorations on the tooth to be analyzed; Sufficient dentin loss that requires restorative treatment or periodontal surgery; Having undergone any professional desensitizing treatment in the previous six months; Having used a desensitizing paste in the previous three months; Use of anti-inflammatory drugs or analgesics at the time of recruitment; Currently pregnant or nursing.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The datasets (Excel spreadsheets) generated from this protocol will be available with the corresponding author (Sandra Kalil Bussadori - sandra.skb@gmail.com) at a reasonable request. However, reuse of this data will not be allowed for people who are not authors of this paper.
    Citations:
    PubMed Identifier
    33692185
    Citation
    Sobral APT, Santos EM, Aranha AC, Soares PV, Moriyama CM, Goncalves MLL, Ribeiro RA, Motta LJ, Horliana ACRT, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. The control of pain due to dentin hypersensitivity in individuals with molar-incisor hypomineralisation: a protocol for a randomised controlled clinical trial. BMJ Open. 2021 Mar 10;11(3):e044653. doi: 10.1136/bmjopen-2020-044653.
    Results Reference
    derived

    Learn more about this trial

    Control of Pain Due to Dentin Hypersensitivity in Individuals With Molar-incisor Hypomineralization

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