Sensitive DentinBDAHMINCT07080645
BIOSILITACE AS A DESENSITIZING AGENTIN HMI
A study testing Pain Relieving and topical application in people with Sensitive Dentin and Hypomineralization Molar Incisor, run by University of Sao Paulo at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Sensitive Dentin, Hypomineralization Molar Incisor, Pain
- What is being tested?
- Pain Relieving and topical application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesBrazil
- Study dates
- 30 Jul 2025to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Paulla IZ Barbosa, Mestre contact
Brazil2 sites
Faculdade de Odontologia de Ribeirão Preto FORP USP
Ribeirão Preto, São Paulo, 14040-904
Profa Msc Paulla Zarpellon Doutoranda, +5591 9 8491 4574, paullazarpellon@usp.br
PAULLA IADDIA ZARPELLON BARBOSA IZ doutoranda
Faculdade de Odontologia de Ribeirão Preto FORP USP
Ribeirão Preto, São Paulo, 14040-904
About this study
Official title: Biosilicate as a Desensitizing Agent in Teeth With Molar Incisor Hypomineralization in Children: A Randomized Clinical 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).
Read the detailed 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.
- Conditions
- Sensitive Dentin, Hypomineralization Molar Incisor, Pain
- Being tested
- Pain Relieving, topical application
- Keywords
- pain, Molar-Incisor Hypomineralization, biosilicate, dentin hypersensitivity, tooth enamel, child
- Medical subject headings
- Dentin Sensitivity, Molar Hypomineralization, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain RelievingOther
Also called Pain relieving dentin, Dentin Hypersensitivity, Molar-Incisor Hypomineralization and Biosilicate
aim to relieve tooth pain with HMI Biosilicate
topical applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Pain Relieving; Other: topical application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start30 Jul 2025 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sensitive DentinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Paulla Iaddia Zarpellon Barbosa, University of Sao Paulo
- Investigators
- doutoranda, Principal investigator, NÃO FILIADO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080645
- Sponsor's protocol ID
- BIOSILIC2025
- Other IDs
- BIOSILC HMI
- Acronym
- BDAHMI
- Status last verified
- Jul 2025
- First submitted
- 2 Apr 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 25219992
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biosilicate as a Desensitizing Agent in Teeth With Molar Incisor Hypomineralization in Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07080645
- Acronym / sponsor ID
- BDAHMI / BIOSILIC2025
- Conditions
- Sensitive Dentin, Hypomineralization Molar Incisor, Pain
- Keywords
- pain, Molar-Incisor Hypomineralization, biosilicate, dentin hypersensitivity, tooth enamel, child
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Biosilicate® 10% | Experimental | Other: Pain Relieving, Other: topical applicationSupervised 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 |
| Duraphat® | Active comparator | Other: Pain Relieving, Other: topical applicationInitially, 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain RelievingAlso: Pain relieving dentin, Dentin Hypersensitivity, Molar-Incisor Hypomineralization and Biosilicateaim to relieve tooth pain with HMI Biosilicate | Other | Biosilicate® 10%, Duraphat® |
| topical applicationthe 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. | Other | Biosilicate® 10%, Duraphat® |
Primary outcome
The Visual Analogue Scale (VAS)
Time frame: 3 months
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.
1 secondary outcome
Schiff Cold Air Sensitivity Scale (SCASS)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Results publication: PubMed 25219992Shrestha 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paulla IZ Barbosa, Mestre contact
doutoranda principal investigator
NÃO FILIADO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Relieving and topical application in people with Sensitive Dentin and Hypomineralization Molar Incisor, run by University of Sao Paulo at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paulla I Zarpellon Barbosa, Mestre (+5516991040404, paullazarpellon@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Visual Analogue Scale (VAS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07080645, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.