Interventions to Control Hypersensitivity Pain in Teeth With Insisive Molar Hypomineralization

Summary

Molar incisor hypomineralization (MIH) manifests as a qualitative, demarcated defect in tooth enamel of systemic origin, predominantly affecting one or more permanent first molars, and potentially extending to the incisors. One significant challenge in managing this enamel anomaly is hypersensitivity, leading to discomfort and pain in affected patients. Low-intensity laser therapy, alone or combined with other modalities, appears promising in alleviating pain associated with MIH. This study aims to assess the efficacy of low-intensity laser therapy using varied parameters, in conjunction with a remineralizing agent, for pain management in children with molar incisor hypomineralization. Participants aged 6 to 12 years will be recruited, with a total of 88 teeth diagnosed with MIH, presenting a sensitivity score ≤3 on the Visual Analog Scale (VAS) and a score ≤1 on the Schiff Cold Air Sensitivity Scale (SCASS). The teeth will be randomly assigned to one of four groups (n=22 each): Group I (GI): L-1J + VF, Group II (GII): L-1J + VP, Group III (GIII): L-2J + VF, and Group IV (GIV): L-2J + VP. Here, 'L' denotes low-intensity laser application at different parameters (1J and 2J), combined with either fluoride varnish (VF) or a placebo varnish (VP). Interventions and assessments will be conducted initially, after 48 hours, and at 1 and 2 weeks post-treatment. Patients will undergo re-evaluation at 2, 4, 8, and 12 weeks following interventions. Statistical analyses will be performed with a 95% confidence level (α = 0.05).

Conditions

• Molar Incisor Hypomineralization

Interventions

DRUG

Fluoride Varnishes

the investigators will utilize a fluoride varnish with a concentration of 22,600 ppm F. The application will be facilitated using a microbrush, ensuring thorough coverage over the entire length of the lesion for a duration of 30 seconds. Following application, the varnish will be finished with water to create a film on the tooth surface. After completing the interventions, patients will receive instructions to refrain from consuming hard foods and to postpone tooth brushing for at least four hours, adhering to the manufacturer's recommendations.

DRUG

Varnishes placebo

the investigators will apply a placebo varnish without the active ingredient (fluoride), ensuring that it is packaged identically to the fluoride varnish and has the same taste and texture, thus maintaining consistency in application. The varnish will be applied using a microbrush, spreading it evenly over the entire length of the lesion for a duration of 30 seconds. Following the interventions, patients will receive instructions to avoid consuming hard foods and to delay tooth brushing for at least four hours after applying the varnish.

RADIATION

Low-Intensity Laser 1J

The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 1 Joule, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion.

RADIATION

Low-Intensity Laser 2J

The tooth will undergo low-intensity laser irradiation in continuous mode, employing a wavelength of 808 nm, a power output of 100 mW, a dose of 2 Joules, and a fluence of 35 J/cm\^2. The laser will be positioned perpendicular to the tooth surface, targeting the cervical third of the buccal surface (both mesial and distal aspects), as well as the center of the lesion.

Sponsors & Collaborators

• University of Sao Paulo

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2025-01-03

Completion

2025-01-07

FDA Drug

Yes

FDA Device

Yes

Countries

• Brazil

Study Locations