Molar-Incisor HypomineralizationNCT06180369
Clinical Efficacies of Different Agents in Molar-Incisor Hypomineralization
A study testing GC Fuji Triage ® GC America Inc., Alsip, Illinois ) and BeutiSealant (Shofu, Kyoto, Japonya) in people with Molar-Incisor Hypomineralization, run by Marmara University.
Trial summary
This study aims to assess the clinical effectiveness of GC Fuji Triage ® (GC America Inc., Alsip, Illinois) and BeutiSealant (Shofu, Kyoto, Japan) in children aged 8-13 with multiple molars affected by Molar-Incisor Hypomineralization (MIH). The comparison focuses on permanent first molars affected by MIH. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar-Incisor Hypomineralization
- What is being tested?
- GC Fuji Triage ® GC America Inc., Alsip, Illinois ) and BeutiSealant (Shofu, Kyoto, Japonya)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 8-13 with hypomineralization in their first permanent molars.
- Children without systemic diseases or developmental dental anomalies that could affect hypomineralization.
- Those with at least two molars exhibiting molar-incisor hypomineralization (MIH), specifically scoring 1 and 3 according to the MIH-Tll index.
- Children with a positive or 'definitely positive' cooperation according to the Frankl Behavior Rating Scale (Frankl et al., 1962).
- Absence of spontaneous pain, abscess, mobility, or inter-radicular lesions in the tooth to be treated.
- Patients or their parents consenting to participate in the treatment.
Who cannot join
- Children with systemic diseases or developmental dental anomalies that could affect hypomineralization.
- To have MIH outside the specified scores.
- Children unable to continue treatment in the chair due to cooperation problems.
- Failure to attend control sessions or a desire not to continue with the study.
- Patients and their parents unwilling to participate in the treatment.
- If the patient cannot attend control sessions or disrupts sessions, they will be withdrawn from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Clinical Efficacies of Different Agents in Molar-Incisor Hypomineralization-Affected Molars
This study aims to assess the clinical effectiveness of GC Fuji Triage ® (GC America Inc., Alsip, Illinois) and BeutiSealant (Shofu, Kyoto, Japan) in children aged 8-13 with multiple molars affected by Molar-Incisor Hypomineralization (MIH). The comparison focuses on permanent first molars affected by MIH.
Read the detailed description
The study targets children within the specified age range with MIH-affected molars, comparing the clinical outcomes of GC Fuji Triage and BeutiSealant. The assessment will provide valuable insights into the efficacy of these agents in managing severe hypomineralization, contributing to our understanding of effective treatment modalities for MIH.
The evaluation criteria include restoration success, prevention of further decay development, prevention of post-eruption breakdown, alleviation of tooth sensitivity, and measurement of life quality. These criteria will be compared with those of Resin Fissure Sealant.
- Conditions
- Molar-Incisor Hypomineralization
- Being tested
- GC Fuji Triage ® GC America Inc., Alsip, Illinois ), BeutiSealant (Shofu, Kyoto, Japonya)
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC Fuji Triage ® GC America Inc., Alsip, Illinois )Other
Fissur Sealent application
BeutiSealant (Shofu, Kyoto, Japonya)Other
Fissur Sealent application
| Study group | Role | What they receive |
|---|---|---|
| GC Fuji Triage ® GC America Inc., Alsip, Illinois ) | Other | Fissure sealant application with GC Fuji Triage (GC America Inc., Alsip, Illinois ) Receives: Other: GC Fuji Triage ® GC America Inc., Alsip, Illinois ) |
| BeutiSealant (Shofu, Kyoto, Japonya) | Other | Fissure sealant application with BeutiSealant (Shofu, Kyoto, Japonya) Receives: Other: BeutiSealant (Shofu, Kyoto, Japonya) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Schiff Cold Air Sensitivity Score
The Schiff Cold Air Sensitivity Score is a test conducted in dental units. Cold air from a spray is applied to the surface of the tooth's dentin, 2-3 mm away, and at a 90-degree angle, with continuous pressure of 45-60 PSI for 2-3 seconds, following the isolation of neighboring teeth. The temperature should be around 20 degrees Celsius. The patient's pain level is then scored by the dentist using a scale.
- Score 0: No response to the stimulus.
- Score 1: Responds to the stimulus but does not request it to be stopped.
- Score 2: Responds to the stimulus, requests it to be stopped, or makes movements to avoid it.
- Score 3: Responds to the stimulus, finds it painful, and requests it to be stopped.
Measured: 1.5 -2 year
Parent Satisfaction
Parent Satisfaction: To assess parental satisfaction regarding the applied restoration, a Likert-type scale will be used to score crowns based on their appearance, color, shape, size, and overall aesthetic (Suguna and Gurunathan, 2021).
- Not satisfied at all
- Not satisfied
- Neither satisfied nor dissatisfied (Neutral)
- Satisfied
- Very satisfied
Measured: 1.5-2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2023
- Study startDec 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar-Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06180369
- Sponsor's protocol ID
- MarmaraPedo3
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Efficacies of Different Agents in Molar-Incisor Hypomineralization-Affected Molars
- ClinicalTrials.gov ID
- NCT06180369
- Acronym / sponsor ID
- MarmaraPedo3
- Conditions
- Molar-Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 22 Dec 2023 (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.
This study aims to assess the clinical effectiveness of GC Fuji Triage ® (GC America Inc., Alsip, Illinois) and BeutiSealant (Shofu, Kyoto, Japan) in children aged 8-13 with multiple molars affected by Molar-Incisor Hypomineralization (MIH). The comparison focuses on permanent first molars affected by MIH.
Detailed description
The study targets children within the specified age range with MIH-affected molars, comparing the clinical outcomes of GC Fuji Triage and BeutiSealant. The assessment will provide valuable insights into the efficacy of these agents in managing severe hypomineralization, contributing to our understanding of effective treatment modalities for MIH.
The evaluation criteria include restoration success, prevention of further decay development, prevention of post-eruption breakdown, alleviation of tooth sensitivity, and measurement of life quality. These criteria will be compared with those of Resin Fissure Sealant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC Fuji Triage ® GC America Inc., Alsip, Illinois ) | Other | Other: GC Fuji Triage ® GC America Inc., Alsip, Illinois )Fissure sealant application with GC Fuji Triage (GC America Inc., Alsip, Illinois ) |
| BeutiSealant (Shofu, Kyoto, Japonya) | Other | Other: BeutiSealant (Shofu, Kyoto, Japonya)Fissure sealant application with BeutiSealant (Shofu, Kyoto, Japonya) |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy children aged 8-13 with hypomineralization in their first permanent molars.
- Children without systemic diseases or developmental dental anomalies that could affect hypomineralization.
- Those with at least two molars exhibiting molar-incisor hypomineralization (MIH), specifically scoring 1 and 3 according to the MIH-Tll index.
- Children with a positive or 'definitely positive' cooperation according to the Frankl Behavior Rating Scale (Frankl et al., 1962).
- Absence of spontaneous pain, abscess, mobility, or inter-radicular lesions in the tooth to be treated.
Key exclusion criteria (6 listed)
- Children with systemic diseases or developmental dental anomalies that could affect hypomineralization.
- To have MIH outside the specified scores.
- Children unable to continue treatment in the chair due to cooperation problems.
- Failure to attend control sessions or a desire not to continue with the study.
- Patients and their parents unwilling to participate in the treatment.
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 |
|---|---|---|
| GC Fuji Triage ® GC America Inc., Alsip, Illinois )Fissur Sealent application | Other | GC Fuji Triage ® GC America Inc., Alsip, Illinois ) |
| BeutiSealant (Shofu, Kyoto, Japonya)Fissur Sealent application | Other | BeutiSealant (Shofu, Kyoto, Japonya) |
Primary outcome
The Schiff Cold Air Sensitivity Score
Time frame: 1.5 -2 year
The Schiff Cold Air Sensitivity Score is a test conducted in dental units. Cold air from a spray is applied to the surface of the tooth's dentin, 2-3 mm away, and at a 90-degree angle, with continuous pressure of 45-60 PSI for 2-3 seconds, following the isolation of neighboring teeth. The temperature should be around 20 degrees Celsius. The patient's pain level is then scored by the dentist using a scale. * Score 0: No response to the stimulus. * Score 1: Responds to the stimulus but does not request it to be stopped. * Score 2: Responds to the stimulus, requests it to be stopped, or makes movements to avoid it. * Score 3: Responds to the stimulus, finds it painful, and requests it to be stopped.
Parent Satisfaction
Time frame: 1.5-2 year
Parent Satisfaction: To assess parental satisfaction regarding the applied restoration, a Likert-type scale will be used to score crowns based on their appearance, color, shape, size, and overall aesthetic (Suguna and Gurunathan, 2021). 1. Not satisfied at all 2. Not satisfied 3. Neither satisfied nor dissatisfied (Neutral) 4. Satisfied 5. Very satisfied
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing GC Fuji Triage ® GC America Inc., Alsip, Illinois ) and BeutiSealant (Shofu, Kyoto, Japonya) in people with Molar-Incisor Hypomineralization, run by Marmara University.
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 6 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: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Betül Sen Yavuz, DDS (+905399887646, dt.betulsen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Schiff Cold Air Sensitivity Score (time frame: 1.5 -2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2023.