Molar Incisor HypomineralizationNCT07504614
Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH).
A study testing Pre-etched Bioactive Sealant and Conventional Resin-based Sealant in people with Molar Incisor Hypomineralization and Fissure Sealant, run by Jordan University of Science and Technology at 1 site in Jordan.
Trial summary
This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization, Fissure Sealant
- What is being tested?
- Pre-etched Bioactive Sealant and Conventional Resin-based Sealant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteJordan
- Study dates
- 1 Aug 2025to 30 Aug 2027
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-12-year-old patients with at least one fully erupted first permanent molar (FPM) diagnosed with MIH defects (White, creamy, or yellow to brownish opacities greater than one millimetre) without posteruptive enamel breakdown or caries (ICDAS code 0 or 1).
- Non -contributory medical history
- Children must exhibit sufficient cooperation for treatment.
- FPMs status of eruption must allow for proper isolation. Exclusion Criteria:-
- Medically compromised patient.- Partially erupted MIH first permanent molars that could not be sufficiently isolated.
- Carious molars.
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- Restored MIH molars.
- Sealed MIH molars.
- MIH molars with extensive enamel breakdown that requires restoration.
- MIH molars planned for extraction (compensatory or balancing extraction) as part of elective extraction plan of MIH molars with poor long-term prognosis.
- Molars affected with other enamel defects ((e.g., amelogenesis imperfecta or fluorosis)
- Non-MIH affected molars.
- Parents did not consent for treatment.
- Child not sufficiently cooperative for treatment.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH): A Randomized Clinical Trial
This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity.
Read the detailed description
Molar Incisor Hypomineralization (MIH) poses a significant clinical challenge in pediatric dentistry due to enamel fragility, hypersensitivity, and increased susceptibility to caries. While conventional resin-based fissure sealant (RBFS) is the gold standard fissure sealant material for occlusal caries, its performance on hypomineralized enamel remains suboptimal. Bioactive sealants are newly developed materials that promote remineralization and utilize both mechanical and chemical adhesion; however, they demonstrate poor retention when used with their self-etching primer. Bioactive sealants with phosphoric acid pre-etching may offer improved clinical outcomes for MIH-affected teeth. This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity. Participants will be randomly allocated to receive either a bioactive sealant with phosphoric acid pre-etching or conventional RBFS. Clinical evaluations will be performed at 3-, 6-, and 12- months post-application using Modified United States Public Health Service (USPHS) criteria to assess retention, marginal adaptation, and secondary caries formation. Pre and postoperative sensitivity will be measured using the Schiff Cold Air Sensitivity Scale (SCASS).
- Conditions
- Molar Incisor Hypomineralization, Fissure Sealant
- Being tested
- Pre-etched Bioactive Sealant, Conventional Resin-based Sealant
- Keywords
- Molar Incisor Hypomineralization, Fissure sealant, Children, Bioactive Dental material
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-etched Bioactive SealantProcedure or surgery
Application of the bioactive sealant after etching, washing, drying, and primer use.
Conventional Resin-based SealantProcedure or surgery
Application of resin-based fissure sealant after etching, washing, drying and bonding.
| Study group | Role | What they receive |
|---|---|---|
| Pre-etched Bioactive Sealant | Experimental | Bioactive fissure sealant applied after etching with phosphoric acid Receives: Procedure: Pre-etched Bioactive Sealant |
| Resin-based fissure sealant | Active comparator | Resin-based fissure sealant is applied after etching with phosphoric acid Receives: Procedure: Conventional Resin-based Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sealant retention
Evaluation of sealant retention using the Modified United States Public Health Service (USPHS) criteria under good light source and using a dental mirror and a straight explorer
Measured: 3,6 and 12 months
Marginal integrity
Evaluation for the presence of fractures or gaps in the sealant-tooth interface using the Modified United States Public Health Service (USPHS) criteria under a good light source and using a dental mirror and straight explorer.
Measured: 3,6 and 12 months
Marginal discoloration
Evaluation for marginal discolouration using the Modified United States Public Health Service (USPHS) criteria under good light source and using a dental mirror
Measured: 3,6 and 12 months
Secondary Caries
Evaluation for new caries using the Modified United States Public Health Service (USPHS) criteria under a good light source and using a dental mirror and a straight explorer.
Measured: 3,6 and 12 months
Anatomic form
Evaluation of anatomic form using the modified United States of Public Health Service Criteria.
Measured: 3,6 and 12 months
Surface Texture
Evaluation for surface texture using the modified United States of Public Health Service Criteria
Measured: 3,6 and 12 months
Secondary outcomes (1)
Sensitivity
Evaluation of pre-operative and post-operative sensitivity using the Schiff Cold Air Sensitivity Scale (SCASS).
Measured: Pre-operative, 3,6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Aug 2025
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504614
- Sponsor's protocol ID
- 196-2025
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-etched Bioactive Versus Resin- Based Fissure Sealant for Permanent Molars Affected With Molar Incisor Hypomineralization (MIH): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07504614
- Acronym / sponsor ID
- 196-2025
- Conditions
- Molar Incisor Hypomineralization, Fissure Sealant
- Keywords
- Molar Incisor Hypomineralization, Fissure sealant, Children, Bioactive Dental material
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Jordan University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 1 Apr 2026 (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 evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity.
Detailed description
Molar Incisor Hypomineralization (MIH) poses a significant clinical challenge in pediatric dentistry due to enamel fragility, hypersensitivity, and increased susceptibility to caries. While conventional resin-based fissure sealant (RBFS) is the gold standard fissure sealant material for occlusal caries, its performance on hypomineralized enamel remains suboptimal. Bioactive sealants are newly developed materials that promote remineralization and utilize both mechanical and chemical adhesion; however, they demonstrate poor retention when used with their self-etching primer. Bioactive sealants with phosphoric acid pre-etching may offer improved clinical outcomes for MIH-affected teeth. This study aims to evaluate and compare the clinical performance of pre-etched bioactive fissure sealants to conventional RBFS in permanent molars affected by MIH in terms of retention, marginal integrity, caries prevention effect, and sensitivity. Participants will be randomly allocated to receive either a bioactive sealant with phosphoric acid pre-etching or conventional RBFS. Clinical evaluations will be performed at 3-, 6-, and 12- months post-application using Modified United States Public Health Service (USPHS) criteria to assess retention, marginal adaptation, and secondary caries formation. Pre and postoperative sensitivity will be measured using the Schiff Cold Air Sensitivity Scale (SCASS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-etched Bioactive Sealant | Experimental | Procedure: Pre-etched Bioactive SealantBioactive fissure sealant applied after etching with phosphoric acid |
| Resin-based fissure sealant | Active comparator | Procedure: Conventional Resin-based SealantResin-based fissure sealant is applied after etching with phosphoric acid |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 6-12-year-old patients with at least one fully erupted first permanent molar (FPM) diagnosed with MIH defects (White, creamy, or yellow to brownish opacities greater than one millimetre) without posteruptive enamel breakdown or caries (ICDAS code 0 or 1).
- Non -contributory medical history
- Children must exhibit sufficient cooperation for treatment.
- FPMs status of eruption must allow for proper isolation. Exclusion Criteria:-
- Medically compromised patient.- Partially erupted MIH first permanent molars that could not be sufficiently isolated.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Pre-etched Bioactive SealantApplication of the bioactive sealant after etching, washing, drying, and primer use. | Procedure or surgery | Pre-etched Bioactive Sealant |
| Conventional Resin-based SealantApplication of resin-based fissure sealant after etching, washing, drying and bonding. | Procedure or surgery | Resin-based fissure sealant |
Primary outcome
Sealant retention
Time frame: 3,6 and 12 months
Evaluation of sealant retention using the Modified United States Public Health Service (USPHS) criteria under good light source and using a dental mirror and a straight explorer
Marginal integrity
Time frame: 3,6 and 12 months
Evaluation for the presence of fractures or gaps in the sealant-tooth interface using the Modified United States Public Health Service (USPHS) criteria under a good light source and using a dental mirror and straight explorer.
Marginal discoloration
Time frame: 3,6 and 12 months
Evaluation for marginal discolouration using the Modified United States Public Health Service (USPHS) criteria under good light source and using a dental mirror
Secondary Caries
Time frame: 3,6 and 12 months
Evaluation for new caries using the Modified United States Public Health Service (USPHS) criteria under a good light source and using a dental mirror and a straight explorer.
Anatomic form
Time frame: 3,6 and 12 months
Evaluation of anatomic form using the modified United States of Public Health Service Criteria.
Surface Texture
Time frame: 3,6 and 12 months
Evaluation for surface texture using the modified United States of Public Health Service Criteria
1 secondary outcome
Sensitivity
Time frame: Pre-operative, 3,6, and 12 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 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-etched Bioactive Sealant and Conventional Resin-based Sealant in people with Molar Incisor Hypomineralization and Fissure Sealant, run by Jordan University of Science and Technology at 1 site in Jordan.
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 14 inclusion and 0 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: enrolling by invitation, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sealant retention (time frame: 3,6 and 12 months). The study lists 6 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 11 Aug 2026.