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

Phase 1

• Conditions: Molar Incisor Hypomineralization; Dentin Sensitivity
• Interventions: Other: Hygiene Instructions; Procedure: Sealant application; Radiation: Low-level Laser

• Registration Number: NCT04407702
• Lead Sponsor: University of Nove de Julho

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-29
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-25
• Last Update Posted: 2020-11-30
• Study Start: 2021-01-01
• Primary Completion: 2021-08-30
• Study Completion: 2021-12-10

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sealant Group	Hygiene Instructions	The volunteers in this group will receive treatment with sealant (Permaseal - Ultradent), which is a photopolymerizable methacrylate-based resin.
Sealant Group	Sealant application	The volunteers in this group will receive treatment with sealant (Permaseal - Ultradent), which is a photopolymerizable methacrylate-based resin.
Low Level Laser + Sealant Group	Hygiene Instructions	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.
Low Level Laser + Sealant Group	Sealant application	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.
Control Group	Hygiene Instructions	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.
Low-Level Laser Group	Low-level Laser	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.
Low Level Laser + Sealant Group	Low-level Laser	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.
Low-Level Laser Group	Hygiene Instructions	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.

Primary Outcome Measures

Name	Time	Method
Change in pain evaluated through a Visual Analog Scale (VAS)	Baseline, one week, one month, three months and six months after the final treatment session.	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.