Pain Control in Dentin Hypersensitivity in Patients With MIH

Hypersensitivity Dentin Clinical Trial

Official title:

Pain Control in Dentin Hypersensitivity in Patients With MIH: Study Protocol for a Randomized, Controlled, Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04268238
• Other study ID #: HMI
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: March 20, 2020
• Est. completion date: December 20, 2020

Study information

• Verified date: February 2020
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: December 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dentin Sensitivity
• Hypersensitivity
• Hypersensitivity Dentin

Intervention

Procedure:
• 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).
• Sealant Application
Permaseal (Ultradent) is an unloaded resin based on methacrylate and photopolymerizable. 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 for 5 seconds to the tooth surface and light curing for 20 seconds. After that, it is necessary to evaluate occlusion.

Radiation:
• Low Level Laser Application
Volunteers will receive irradiation with AsGaAl laser, wavelength of 780nm (Laser XT Therapy, DMC, São Carlos, SP) with fixed power of 100mW, density of energy of 35 J/cm2 (considering a spot size of 0.028cm2 of this equipment), the dose will be 1 J per point. 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.

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	Change in Pain Evaluated by a Visual Analog Scale (VAS)	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.	Baseline, immediately after treatment, 1 week, 1, 3 and 6 months after treatment.