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Three Restorative Protocols in MIH: a Randomized Controlled Clinical Study

NCT03760497 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-09-28

No results posted yet for this study

Summary

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.

Conditions

  • Molar Incisor Hypomineralization

Interventions

PROCEDURE

Restorative treatment

For all groups, first the patients will be submitted to the anesthetic technique indicated with Lidocaine + Epinephrine 1: 100,000 (New DFL, Rio de Janeiro, Brazil), followed by absolute isolation with rubber sheet and metal clamp; then prophylaxis of the selected tooth will be performed with Robson's brush and pumice stone and water, surface washing and drying with cotton balls, removal of carious tissue or affected enamel without dentin support with sharp curettes or low-speed spherical drills. Subsequently, each group will follow the treatment protocols suggested by the manufacturer of restorative materials.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-31
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Device
Yes

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03760497 on ClinicalTrials.gov