Three Restorative Protocols in MIH: a Randomized Controlled Clinical Study

University of Sao Paulo

Status: Unknown

Conditions: Molar Incisor Hypomineralization

Treatments: Procedure: Restorative treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03760497

MIHFORPUSP

Details and patient eligibility

About

Molar-Incisive Hipomineralization (MIH) is defined as a qualitative change in tooth enamel of systemic origin, which affects one or more permanent first molars, and may or may not involve permanent incisors. MIH has several clinical repercussions, such as presence of hypersensitivity, difficulty in local anesthesia, reduction of restorations longevity, among others, making it difficult to perform dental treatment. Therefore, the present study will evaluate, through a randomized controlled clinical study, three restorative protocols for the treatment of severe MIH (with post eruptive enamel fracture and dentin exposure). The following groups will be evaluated: direct restoration with composite resin; restoration with composite resin with diode laser application and temporary restoration with glass ionomer cement followed by restoration with composite resin). The restorations will be evaluated after 1 week, 1, 6, 12, 18 and 24 months. The main outcome will be evaluation of restoration longevity, presence of caries lesion and wear of the restoration surface. Other outcomes such as patient satisfaction with treatment, patient discomfort, anxiety, assessment of dentin sensitivity and impact on participants' quality of life, as well as the duration and cost of treatment, as well as their cost-effectiveness ratio will also be evaluated . Multilevel statistical analyzes will be performed to verify the effectiveness of diode laser treatment compared to sealing, in addition to possible factors associated with this efficacy.

Enrollment: 300 estimated patients

Sex: All

Ages: 6 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least one permanent first molar with occlusal surface with severe MIH grade (with post eruptive enamel fracture and dentin exposure), it may not be reported hypersensitivity in the selected tooth.

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups

CIV Group

Experimental group

Description:

Temporary Restoration with Glass Ionomer (Equia Forte® - GC Corporation, Tokyo, Japan) for 30 days + Restoration in Composite Resin (Filtek® Resin Z350 XT - 3M Corporate Headquarters, St. Paul, USA).

Treatment:

Procedure: Restorative treatment

Composite Resin Group

Experimental group

Description:

Restoration with Composite Resin (Filtek® Resin Z350 XT - 3M Corporate Headquarters, St. Paul, United States).

Treatment:

Procedure: Restorative treatment

Composite Resin Group + Laser

Experimental group

Description:

Composite Resin Restoration (Filtek® Resin Z350 XT - 3M Corporate Headquarters, St. Paul, USA) + Application of Diode Laser.

Treatment:

Procedure: Restorative treatment