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

Hypomineralization Molar Incisor Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05370417
• Other study ID #: PBMDHMI
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2022
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 30, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Hypomineralization Molar Incisor

Intervention

Other:
• Use of fluoride toothpaste
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.

Radiation:
• Laser Therapy
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.

Procedure:
• Simulated Laser Therapy
The same application described in the laser therapy group will be simulated, with the device turned off.
• Sealant application
A glass ionomer sealant will be applied to the occlusal surface of the first permanent molar.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 48 hours after the procedures and 1 month after.
Secondary	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.	Baseline, 48 hours after the procedures and 1 month after.
Secondary	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	Baseline, 48 hours after the procedures and 1 month after.
Secondary	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).	Baseline, 48 hours after the procedures and 1 month after.