Three Restorative Protocols in MIH: a Randomized Controlled Clinical Study

NCT03760497 | Unknown FDA Device

• 1 other identifier: MIHFORPUSP
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lasers; Hipomineralization of dental enamel; Preventive dentistry; Glass ionomer cement

Outcome Measures

Primary Outcomes (5)

• Longevity of restorations

  The main purpose will be the longevity of the desserts in elaborate compounds, according to the three protocols. Images should be analyzed and scanned. Radiographic examination and digital radiography. After 6, 12 and 24 months.

  24 months.

• Treatment satisfaction as assessed by VAS scale (Index 0 to 10)

  After 1 week of treatment, 1, 12 and 24 months, the caregiver will be asked to respond about the satisfaction regarding the care (treatment and returns) received. He should classify his satisfaction using the VAS scale with indexes from 0 to 10, with 0 being the worst treatment evaluation and 10 being the best.

  After 1 week of treatment, 1, 12 and 24 months.

• Discomfort referred by the children assessed by Wong-Baker Facial Scale (Very smiling to very sad)

  In order to assess the discomfort reported by the children in relation to the type of treatment received, the same timekeeping operator will apply the Wong-Baker Facial Scale to the patient, which is composed of six figures with equidistant faces. that the first one is very smiling and the expressions are changing, until the last one is very sad.

  On treatment day

• Quality of life assessed by Child Perceptions Questionnaire 8-10 (CPQ8-10) (Assessed by questions)

  To assess the impact of MIH on children's quality of life, the Child Perceptions Questionnaire 8-10 (CPQ8-10), specially developed for children aged 8-10 years and validated in the Portuguese language. This scale was assessed through questions and answers to a children's quality of life.

  On treatment day

• Anxiety Assessment

  For the assessment of anxiety in the study children, the Children's Fear Survey Schedule-Dental Subscale will be used

  On treatment day

Secondary Outcomes (8)

• Socioeconomic questionnaire

  On treatment day

• Evaluation of the caries experience

  On treatment day

• Presence of biofilm visible

  On treatment day

• Evaluation of the visible biofilm accumulated on the occlusal surface

  On treatment day

• Evaluation of the presence of visible biofilm on the buccal surfaces of the molars to be evaluated

  On treatment day

Study Arms (3)

CIV Group

EXPERIMENTAL

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).

Procedure: Restorative treatment

Composite Resin Group

EXPERIMENTAL

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

Procedure: Restorative treatment

Composite Resin Group + Laser

EXPERIMENTAL

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

Procedure: Restorative treatment

Interventions

Restorative treatment PROCEDURE

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.

CIV Group; Composite Resin Group; Composite Resin Group + Laser

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Dentistry of Ribeirao Preto

Ribeirão Preto, São Paulo, 14040-904, Brazil

RECRUITING

MeSH Terms

Conditions

Molar Hypomineralization

Interventions

Dental Atraumatic Restorative Treatment

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)

Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Comparison of Three Restorative Protocols in Teeth With Molar-Incisor Hipomineralization (MIH): a Randomized Controlled Clinical Study

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 30, 2018
• Study Start: December 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

BR (1)