BIOSILITACE AS A DESENSITIZING AGENTIN HMI

ConditionsSensitive Dentin Hypomineralization Molar Incisor Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-12

SponsorUniversity of Sao Paulo

About this trial

Molar-Incisor Hypomineralization (MIH) is a qualitative enamel defect caused by systemic hypomineralization that affects one to four first permanent molars, and may or may not involve incisors. The clinical repercussions associated with MIH can be characterized by: painful hypersensitivity, post-eruptive fractures, rapid progression of caries lesions in newly erupted first permanent molars, difficulty in achieving effective anesthesia, aesthetic impairments, and patient fear and anxiety. To date, there is no consensus on the best treatment for sensitivity in teeth with MIH, thus managing sensitivity in these teeth remains a significant challenge. The aim of this study is to evaluate the effectiveness of a 10% Biosilicate® solution as a desensitizing agent in MIH teeth in children, compared to Fluoride varnish (Duraphat® Colgate, Brazil). Children aged 6 to 12 years will be selected for this study, with a total of 63 participants diagnosed with MIH, and a sensitivity score ≥2 on the SCASS scale. The children will be randomly divided into two groups (n=21): GI: Duraphat®, GII: Biosilicate®. Interventions will be performed once a week for 4 consecutive weeks, followed by 8 weeks of follow-up. The results will be subjected to statistical tests with a 95% confidence level (α = 0.05).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children of both sexes, aged between 6 and 12 years.

Children who have at least one first permanent molar with Molar-Incisor Hypomineralization, showing distinct white or cream opacity (score 21), yellowish or brown opacity (score 22), and/or post-eruptive enamel fracture (score 3), and presence of painful sensitivity when stimulated, with a score of 2 or 3 as evaluated using the SCASS scale.

Children without systemic and/or cognitive impairments.

Disqualifiers

Previous use of desensitizing therapy in the last 6 months;

Use of analgesic and anti-inflammatory medications during the previous 3 days;

Use of orthodontic appliances;

Teeth with extensive restorative procedures, such as stainless steel crowns, which prevent the assessment of painful sensitivity;

Trial design

Design model

Parallel

Treatments tested in this trial

Pain Relieving
Other intervention
aim to relieve tooth pain with HMI Biosilicate
topical application
Other intervention
the operator will apply a solution to all the free surfaces of the selected teeth using a microapplicator. The solution will either be 10% Biosilicate® solution, fluoride varnish (Duraphat®), or distilled water . All products will be removed from their original containers and placed in identical 10ml plastic bottles, white and standardized. The different products will be applied equally for 15 seconds according to the application protocol.

Treatment groups

42 Participants

are divided into 2 treatment groups

Group A: Biosilicate® 10%Experimental treatment 2 interventions

Group B: Duraphat®Active comparator 2 interventions

Trial outcomes

Primary outcomes

The Visual Analogue Scale (VAS)

VAS (Visual Analog Scale), a psychometric assessment scale to measure the amount of pain the patient feels, which is reported by the patient himself and can vary from no pain (0) to extreme pain (10).The most simple VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). In some studies, horizontal scales are orientated from right to left, and many investigators use vertical VAS.

Time frame

3 months

Secondary outcomes

Schiff Cold Air Sensitivity Scale (SCASS)

The SCASS is scored as follows: 0 = subject does not respond to the stimulus; 1 = subject does not respond to the stimulus, but considers the stimulus painful; 2 = subject responds to the air stimulus and moves away from the stimulus; and 3 = subject responds to the air stimulus, moves away from the stimulus and requests immediate interruption of the stimulus (Schiff et al., 2009).

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo

Lead sponsor

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: