BIOSILITACE AS A DESENSITIZING AGENTIN HMI (BDAHMI)

University of Sao Paulo

Status: Not yet enrolling

Conditions: Sensitive Dentin; Hypomineralization Molar Incisor; Pain

Treatments: Other: Pain Relieving; Other: topical application

Study type: Interventional

Funder types: Other

Identifiers

NCT07080645

BIOSILIC2025

BIOSILC HMI (Other Identifier)

Details and patient eligibility

About

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).

Full description

This study will evaluate the effectiveness of a 10% Biosilicate® solution as a desensitizing agent in MIH teeth in children, compared to Fluoride varnish (Duraphat® Colgate, Brazil). The children included in the study will be subdivided into three randomized treatment options, which are: Group 1: Fluoridated varnish (Duraphat® Colgate, Brazil); Group 2: Biosilicate® 10%. The randomization sequence will be generated using the envelope method. A numerical sequence (1 and 2) will be printed, which will correspond sequentially to the three groups (GI and GII). The numbers will be placed in envelopes with the same characteristics and then sealed. The implementation of the random allocation sequence will be carried out by a single researcher, who will use the previously sealed envelopes along with the numbers corresponding to the treatments to be administered. As each child is included in the study, an envelope will be labeled with the child's name and will only be opened by the operator before the start of the treatment. Children with the potential for inclusion in the research will be referred for clinical examination in the mobile dental unit (Dental Case), and those with at least one first permanent molar affected by MIH and reporting hypersensitivity, with or without structure loss, will be invited to participate. The complaint of sensitivity will be confirmed by applying a 1-second air blast at a distance of 1 centimeter from the occlusal surface of the tooth; a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale (SCASS) will be considered a positive result.

Enrollment: 42 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• Teeth with amelogenesis imperfecta or dentinogenesis imperfecta;
• Children with systemic and/or cognitive impairments.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

Biosilicate® 10%

Experimental group

Description:

Supervised tooth brushing will be performed with fluoride-free toothpaste. Then, the tooth affected by MIH will be cleaned with sterile gauze, isolated with a cotton roll, and subsequently, the operator will apply a solution using a microapplicator to all the free surfaces of the selected teeth. This solution will either be a 10% Biosilicate® solution or fluoride varnish (Duraphat®). 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. Immediately after application, sensitivity tests will be performed using the SCASS and VAS protocols, and will be repeated 1, 2, 4, and 8 weeks after the completion of the treatment. The form for recording the results for each patient is provided in. Biosilicate (Na₂O-CaO-SiO₂-P₂O₅), a finely particulate glass-ceramic with a high degree of crystallinity (\~99.5%), exhibiting an

Treatment:

Other: topical application

Other: Pain Relieving

Duraphat®

Active Comparator group

Description:

Initially, the child will be instructed not to consume any food or drink for up to 40 minutes after the treatment. Oral hygiene instructions will be given, and a kit with a toothbrush and fluoride toothpaste will be provided. In all groups, the treatment protocols will be applied once a week for 4 consecutive weeks. Supervised tooth brushing will be performed with fluoride-free toothpaste, followed by cleaning the tooth affected by MIH with sterile gauze, isolating it with a cotton roll, and then, 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®). 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:

Other: topical application

Other: Pain Relieving