Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 24, 2021
Date Accepted: Sep 20, 2021
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Sensitivity treatments for teeth with Molar-Incisor Hypomineralization (MIH): Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
The sensitivity of teeth with MIH (Molar Incisor Hypomineralization) can affect children’s quality of life and is a challenging problem for dentists. Remineralizing agents such as sodium fluoride varnish seem to reduce sensitivity of teeth with MIH, but long-term clinical trials with large samples are still needed for more consistent results about its effectiveness as a desensitizing agent before its clinical recommendation.
Objective:
This randomized clinical trial aims to compare three treatment interventions for teeth with MIH and hypersensitivity.
Methods:
: 60 children aged 6-10 years presenting with at least one first permanent molar with sensitivity and no loss of enamel will be randomly assigned to three groups: Control group - sodium fluoride varnish (Duraphat®, Colgate); Experimental group I - 4% titanium tetrafluoride varnish (TiF4); and Experimental group II - coating resin containing S-PRG filler (Surface Pre-Reacted Glass ionomer) (SPRG Barrier Coat®, Shofu). The sodium fluoride varnish and 4% titanium tetrafluoride varnish will be applied once a week for 4 consecutive weeks and the S-PRG-Barrier Coat resin will be applied in the first session and the application will be simulated in the following 3 weeks to guarantee the blinding of the study. The primary outcome will be sensitivity level measured in different moments: before each material application, immediately after application or simulation, and 1, 2, 4, and 6 months after the last application/simulation by one examiner using Wong-Baker Facial Scale (WBFS), Schiff's Cold Air Sensitivity Scale (SCASS), and FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability pain scale). As secondary outcomes, the parental satisfaction and child self-reported discomfort after the treatment will be measured with a questionnaire prepared by the researcher. The data will undergo statistical analysis and the significance level will be set at 5%.
Results:
The project was funded in 2018, and enrollment was completed in November 2019. The recruitment of participants is currently under way and the first results are expected to be submitted for publication in 2022.
Conclusions:
If found effective in reducing the patient’s sensitivity with long-term effects, these agents can be considered a treatment choice, and the findings will contribute with the development of a treatment protocol for teeth with sensitivity due to MIH. Clinical Trial: Brazilian Registry of Clinical Trials Universal Trial Number: U1111-1237-6720; http://www.ensaiosclinicos.gov.br/rg/?q=RBR-4BHXPB
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