Interventions to Control Hypersensitivity Pain in Teeth With Insisive Molar Hypomineralization

NCT06426108 | Completed Phase 4 DMC FDA Drug FDA Device

• 2 other identifiers: 63035222.3.0000.5419FORP-USP
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Molar Incisor Hypomineralization; low-intensity Laser; Dental hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Gradual change of hypersensitivity on the visual analogue scale.

  Applying the low intensity laser of 1 joule (10 seconds) in infrared light in continuous mode, using a wavelength of 808 nm, power of 100 mW, dose of 1 or 2 Joules and fluence of 35 J/cm2. As an adjuvant to fluoride varnish (22,600 ppm F), we expect an improvement in hypersensitivity assessed by the visual analogue scale, ranging from 0 (no pain) to 10 (worst possible pain), so that applications performed after 48 hours will decrease, and in 1 and 2 weeks post-treatment, remaining stable during follow-ups at 2, 4, 8 and 12 weeks after interventions. This expectation arises from the known mechanisms of laser action in controlling inflammation and providing analgesia. Furthermore, we also anticipate that fluoride varnish will exert its remineralizing effects, contributing to the overall treatment of the disease.

  Gradual reduction after 48 hours, and at 1 and 2 weeks post-treatment and remaining stable during follow-ups of 2, 4, 8, and 12 weeks following interventions

Secondary Outcomes (1)

• Gradual change of hypersensitivity on the Schiff Cold Air Sensitivity Scale

  Gradual reduction after 48 hours, and at 1 and 2 weeks post-treatment and remaining stable during follow-ups of 2, 4, 8, and 12 weeks following interventions

Study Arms (4)

Low-Intensity Laser 1J + Fluoride Varnish

ACTIVE COMPARATOR

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 vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 1 Joule (equivalent to 10 seconds). In conjunction with the laser therapy, a fluoride varnish (Duraphat®, containing 22,600 ppm F, manufactured by Colgate) will be utilized as an adjuvant. Application will be facilitated using a microbrush, ensuring coverage over the entire extent of the lesion for 30 seconds. Following the interventions, patients will be advised to refrain from consuming hard foods and to postpone tooth brushing for at least four hours post-application of the varnish, adhering to the manufacturer's guidelines.

Drug: Fluoride Varnishes; Radiation: Low-Intensity Laser 1J

Low-Intensity Laser 1J + Placebo

PLACEBO COMPARATOR

The tooth will be subjected to 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 vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 1 Joule (equivalent to 10 seconds). As an adjunct to the laser therapy, a placebo varnish, devoid of the active ingredient (fluoride), will be utilized. The varnish will be applied with the assistance of a microbrush, ensuring coverage over the entire length of the lesion for 30 seconds. Following the interventions, patients will be advised to abstain from consuming hard foods and to postpone tooth brushing for at least four hours post-application of the varnish.

Drug: Varnishes placebo; Radiation: Low-Intensity Laser 1J

Low-Intensity Laser 2J + Fluoride Varnish

EXPERIMENTAL

The tooth will undergo low-intensity laser irradiation in continuous mode, utilizing 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 perpendicularly in contact with the tooth surface, targeting the cervical third of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 2 Joules (equivalent to 20 seconds). As an adjunct to the laser therapy, a fluoride varnish (Duraphat®, containing 22,600 ppm F, manufactured by Colgate) will be utilized. The varnish application will be facilitated using a microbrush, ensuring coverage over the entire length of the lesion for 30 seconds. Following the interventions, patients will be instructed to refrain from consuming hard foods and to postpone tooth brushing for at least four hours after applying the varnish, in accordance with the manufacturer's recommendations.

Drug: Fluoride Varnishes; Radiation: Low-Intensity Laser 2J

Low-Intensity Laser 2J + Placebo.

SHAM COMPARATOR

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 third cervical region of the vestibular surface (both mesial and distal aspects), as well as the center of the lesion, with an activation time of 2 Joules (equivalent to 20 seconds). As an adjunct to the laser therapy, a placebo varnish, devoid of the active ingredient (fluoride), will be utilized.The varnish will be applied with the assistance of a microbrush, ensuring coverage over the entire length of the lesion for 30 seconds. Following the interventions, patients will be advised to abstain from consuming hard foods and to postpone tooth brushing for at least four hours post-application of the varnish.

Drug: Varnishes placebo; Radiation: Low-Intensity Laser 2J

Interventions

Fluoride Varnishes DRUG

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.

Low-Intensity Laser 1J + Fluoride Varnish; Low-Intensity Laser 2J + Fluoride Varnish

Varnishes placebo DRUG

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.

Low-Intensity Laser 1J + Placebo; Low-Intensity Laser 2J + Placebo.

Low-Intensity Laser 1J RADIATION

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.

Low-Intensity Laser 1J + Fluoride Varnish; Low-Intensity Laser 1J + Placebo

Low-Intensity Laser 2J RADIATION

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.

Low-Intensity Laser 2J + Fluoride Varnish; Low-Intensity Laser 2J + Placebo.

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 12 years old
• Teeth diagnosed with MIH, exhibiting at least one erupted permanent molar with the occlusal surface devoid of gingival tissue and showing sensitivity associated with MIH with sensitivity score ≤3 on the Visual Analogue Scale (VAS) and score ≤1 on the Self-Consensus Assessment scale symptoms and signs (SCASS).
• Children who have the cognitive ability to answer the tests.
• Children who obtained authorization from their parents or guardians, through a signed free and informed consent form.

You may not qualify if:

• Decayed or restored teeth.
• Teeth with other enamel defects, such as fluorosis, enamel hypoplasia, amelogenesis imperfecta or enamel malformations associated with syndromes, as well as those undergoing orthodontic treatment.
• Patients with cognitive impairments that prevent responsiveness to the test.
• Children who have undergone desensitizing treatment in the last 3 months.
• Children who use anti-inflammatory and/or analgesic medications before starting treatment.
• Teeth that have a sensitivity score \>3 on the visual analogue scale (VAS) and a score \>1 on the Schiff Cold Air Sensitivity Scale (SCASS).

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Lucas Masaru Marubayashi

Ribeirão Preto, São Paulo, 14040904, Brazil

Location

Related Publications (1)

• Muniz RSC, Carvalho CN, Aranha ACC, Dias FMCS, Ferreira MC. Efficacy of low-level laser therapy associated with fluoride therapy for the desensitisation of molar-incisor hypomineralisation: Randomised clinical trial. Int J Paediatr Dent. 2020 May;30(3):323-333. doi: 10.1111/ipd.12602. Epub 2019 Dec 23.

  PMID: 31808584 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Fluorides, Topical

Condition Hierarchy (Ancestors)

Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Triple blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Randomized placebo controlled triple blind clinical trial

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 23, 2024
• Study Start: July 1, 2024
• Primary Completion: January 3, 2025
• Study Completion: January 7, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)