Clinical trial NCT03760497: Three Restorative Protocols in MIH: a Randomized Controlled Clinical Study
Official title: Comparison of Three Restorative Protocols in Teeth With Molar-Incisor Hipomineralization (MIH): a Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Molar Incisor Hypomineralization
Keywords: Lasers
Hipomineralization of dental enamel
Preventive dentistry
Glass ionomer cement
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Longevity of restorations
timeFrame: 24 months.
measure: Treatment satisfaction as assessed by VAS scale (Index 0 to 10)
timeFrame: After 1 week of treatment, 1, 12 and 24 months.
measure: Discomfort referred by the children assessed by Wong-Baker Facial Scale (Very smiling to very sad)
timeFrame: On treatment day
measure: Quality of life assessed by Child Perceptions Questionnaire 8-10 (CPQ8-10) (Assessed by questions)
timeFrame: On treatment day
measure: Anxiety Assessment
timeFrame: On treatment day
Secondary outcomes:
measure: Socioeconomic questionnaire
timeFrame: On treatment day
measure: Evaluation of the caries experience
timeFrame: On treatment day
measure: Presence of biofilm visible
timeFrame: On treatment day
measure: Evaluation of the visible biofilm accumulated on the occlusal surface
timeFrame: On treatment day
measure: Evaluation of the presence of visible biofilm on the buccal surfaces of the molars to be evaluated
timeFrame: On treatment day
measure: Assessment of eruption degree
timeFrame: On treatment day
measure: Evaluation of lesion extension
timeFrame: On treatment day
measure: Cost of procedures
timeFrame: On treatment day
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: School of Dentistry of Ribeirao Preto
state: São Paulo
Study officials:
References: