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
About this trial
This is an interventional treatment trial for Hypomineralization Molar Incisor
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.
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
NCT ID
NCT05370417
First Posted
May 6, 2022
Last Updated
September 1, 2022
Sponsor
University of Nove de Julho
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
Learn more about this trial
Photobiomodulation and Glass Ionomer Sealant as Complementary Treatment for Hypersensitivity in Molars With MIH
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