BIOSILITACE AS A DESENSITIZING AGENTIN HMI

NCT07080645 | Not Yet Recruiting

• 2 other identifiers: BIOSILIC2025BIOSILC HMI
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Sensitive Dentin; Hypomineralization Molar Incisor; Pain

Keywords

pain; Molar-Incisor Hypomineralization; biosilicate; dentin hypersensitivity; tooth enamel; child

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (1)

• Schiff Cold Air Sensitivity Scale (SCASS)

  3 months

Study Arms (2)

Biosilicate® 10%

EXPERIMENTAL

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

Other: Pain Relieving; Other: topical application

Duraphat®

ACTIVE COMPARATOR

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.

Other: Pain Relieving; Other: topical application

Interventions

Pain Relieving OTHER

aim to relieve tooth pain with HMI Biosilicate

Also known as: Pain relieving dentin, Dentin Hypersensitivity, Molar-Incisor Hypomineralization and Biosilicate

Biosilicate® 10%; Duraphat®

topical application OTHER

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.

Biosilicate® 10%; Duraphat®

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (2)

Faculdade de Odontologia de Ribeirão Preto FORP USP

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Faculdade de Odontologia de Ribeirão Preto FORP USP

Ribeirão Preto, São Paulo, 14040-904, Brazil

Location

Related Publications (1)

• Shrestha R, Upadhaya S, Bajracharya M. Prevalence of molar incisor hypomineralisation among school children in Kavre. Kathmandu Univ Med J (KUMJ). 2014 Jan-Mar;12(45):38-42. doi: 10.3126/kumj.v12i1.13631.

  PMID: 25219992 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Dentin Sensitivity; Molar Hypomineralization; Pain

Interventions

Analgesia; sodium oxide-calcium oxide-silicon dioxide-diphosphorus pentoxide; Fluoride Treatment

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Dental Enamel Hypomineralization; Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Fluoridation; Preventive Dentistry; Dentistry

Study Officials

• doutoranda

  NÃO FILIADO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulla I Zarpellon Barbosa, Mestre

CONTACT

+5516991040404; paullazarpellon@usp.br

Paulla IZ Barbosa, Mestre

CONTACT

paulla.zarp@gamil.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: To ensure the first stage of blinding in the study, the patient will not know which group and type of treatment the tooth will receive. Therefore, we will attempt to standardize some methods to ensure this reliability. The products to be tested will be removed from their original containers and placed in identical 10ml white bottles. The second stage concerns the evaluator. All treatments will be performed by a single operator, and the tests will be applied by another evaluator. In this way, the evaluator will not know the group allocation or the type of intervention that was performed.To increase the reliability of the results, the statistician will also not know the allocation or which groups correspond to each treatment. They will only receive a table with letters representing the groups as A and B and the test values, without knowing which group or interventions were carried out.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PESQUISADOR

Model Details: According to the sample calculation of this study, 42 children (21 per group) will be selected, who have teeth with Molar-Incisor Hypomineralization and painful sensitivity in those teeth, recruited from Municipal Schools in Ribeirão Preto, São Paulo, Brazil, and children treated at the Pediatric Dentistry Clinic and the Dental Enamel Clinic of FORP USP. 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).

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: July 23, 2025
• Study Start: July 30, 2025
• Primary Completion: July 31, 2025
• Study Completion: November 15, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

BR (2)