Pain Control in Dentin Hypersensitivity in Patients With MIH

Phase 1

• Conditions: Hypersensitivity Dentin
• Interventions: Procedure: Hygiene Guidance; Procedure: Sealant Application; Radiation: Low Level Laser Application

• Registration Number: NCT04268238
• Lead Sponsor: University of Nove de Julho

Brief Summary

This study aims to evaluate the effectiveness of different protocols in controlling dentin hypersensitivity in patients with teeth affected by MIH. The subjects will be randomly designated in four experimental groups, according to different treatments. Pain will be assessed with the visual analog scale (Visual Analogue Scale - VAS), after stimulation with air from the triple syringe and and an exploratory probe at the time of (initial) recruitment, immediately after treatment, after 1 week and 1 month, 3 and 6 months after treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-11
• Last Update Submitted: 2020-02-11
• Study First Posted: 2020-02-13
• Last Update Posted: 2020-02-13
• Study Start: 2020-03-20
• Primary Completion: 2020-11-20
• Study Completion: 2020-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Be between 18 and 35 years old;
• Present good general health;
• Present at least one tooth with dentin hypersensitivity reported in the cervical region, which must have a graduated sensitivity equal to or greater than 4 in the VAS scale.

Exclusion Criteria

• Present active caries lesions or restoration defects in the tooth to be analyzed;
• Present sufficient dentin loss that requires restorative treatment or periodontal surgery;
• Volunteers who underwent any professional desensitizer treatment in the last 6 months;
• Volunteers who used desensitizing pastes in the 3 months;
• Volunteers who were using anti-inflammatory or analgesic drugs at the time of recruitment;
• Volunteers who are pregnant or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Hygiene Guidance	Two weeks before the start of the study, the volunteers will go through a wash out period, where they should only use oral care products donated by the researchers, which should be used until the end of the study. The oral hygiene kit will contain 1 toothbrush (Professional Lab Series, Colgate Palmolive), 1 toothpaste without desensitizing agent, but with fluorine (Elmex) and 1 dental floss (Colgate). Afterwards, this group will receive no treatment. Instead of the sealant, water will be used and the laser will remain with power 0W, that is, there will be no light emission, giving the group the characteristic of the control group, no treatment.
Sealant group	Hygiene Guidance	In this group, besides the instructions described in the control group, the teeth that will be sealed will be isolated. 35% phosphoric acid will be applied for 20 seconds and then it will be necessary to wash and dry the tooth surface. Apply a thin layer of PermaSeal (sealant) for 5 seconds to the tooth surface and light curing for 20 seconds.
Sealant group	Sealant Application	In this group, besides the instructions described in the control group, the teeth that will be sealed will be isolated. 35% phosphoric acid will be applied for 20 seconds and then it will be necessary to wash and dry the tooth surface. Apply a thin layer of PermaSeal (sealant) for 5 seconds to the tooth surface and light curing for 20 seconds.
Low Level Laser + Sealant Group	Hygiene Guidance	In this group, patients will receive the treatments described in Control group, Sealant group and Low Level Laser Group.
Low Level Laser Group	Hygiene Guidance	In this group, besides the instructions described in the control group, volunteers will receive irradiation with AsGaAl laser, wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP) with fixed power of 100mW, energy density of 35 J/cm2 (considering a spot size of 0.028 cm2 of this equipment), the dose will be 1 J per point. The irradiation will be performed at a cervical, an apical point and another point exactly on the injury, totaling a dose of 3J. Treatment should be performed in 3 sessions with an ideal 72-hour interval between them.
Low Level Laser Group	Low Level Laser Application	In this group, besides the instructions described in the control group, volunteers will receive irradiation with AsGaAl laser, wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP) with fixed power of 100mW, energy density of 35 J/cm2 (considering a spot size of 0.028 cm2 of this equipment), the dose will be 1 J per point. The irradiation will be performed at a cervical, an apical point and another point exactly on the injury, totaling a dose of 3J. Treatment should be performed in 3 sessions with an ideal 72-hour interval between them.
Low Level Laser + Sealant Group	Sealant Application	In this group, patients will receive the treatments described in Control group, Sealant group and Low Level Laser Group.
Low Level Laser + Sealant Group	Low Level Laser Application	In this group, patients will receive the treatments described in Control group, Sealant group and Low Level Laser Group.

Primary Outcome Measures

Name	Time	Method
Change in Pain Evaluated by a Visual Analog Scale (VAS)	Baseline, immediately after treatment, 1 week, 1, 3 and 6 months after treatment.	Pain will be assessed with the visual analogue scale (Visual Analogue Scale - VAS), after stimulation with air from the triple syringe and an explorer probe.