Molar Hypomineralization, IncisorMIH RCTNCT07732790
Clinical Evaluation of Two Fissure Sealants (Resin Based Versus Giomer Fissure Sealants) on Molar Incisor Hypominerlisation Affected Permanent Molars (RCT)
A study testing Resin based fissure sealant (Fisseal) and Giomer based fissure sealant ( Beautisealant) in people with Molar Hypomineralization, Incisor and Fissure Sealant, run by National Research Centre, Egypt at 1 site in Egypt.
Trial summary
This study aims to compare the effect of two types of fissure sealant a resin based and giomer based in molar incisor hypominerlisation first permanent molars Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Molar Hypomineralization, Incisor, Fissure Sealant, Resin Based Sealers
- What is being tested?
- Resin based fissure sealant (Fisseal) and Giomer based fissure sealant ( Beautisealant)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jun 2025to 10 Jul 2026
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Apparently Healthy Children aged 6-12 years having at least one fully erupted First Permanent Molar (FPM) with MIH indicated for non-invasive fissure sealant.
- Cooperative children.
- Occlusal mild MIH defects (demarcated white, yellow or brown lesions)
- sound surfaces and no incipient enamel caries, where moist control can be achieved.
Who cannot join
- Children having hypomineralized FPMs with post eruption breakdown (PEB).
- Cavitated carious lesions.
- Restorations, fixed orthodontic appliances.
- Enamel defect(s) due to a condition other than MIH.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Resin Based Versus Giomer Fissure Sealants on MIH Affected Permanent Molars (RCT)
This study aims to compare the effect of two types of fissure sealant a resin based and giomer based in molar incisor hypominerlisation first permanent molars
- Being tested
- Resin based fissure sealant (Fisseal), Giomer based fissure sealant ( Beautisealant)
- Keywords
- MIH, resin based sealer, giomer based sealer, first permanent molar
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin based fissure sealant (Fisseal)Other
Fisseal is a light-curing, fluoride-releasing pit and fissure sealant. composition: Methacrylate Monomers, Inorganic Fillers, Photoinitiator System and Sodium Fluoride.
Giomer based fissure sealant ( Beautisealant)Other
BeautiSealant is a fluoride-releasing pit and fissure sealant that features Giomer technology. it's BPA- and HEMA-free pit and fissure sealant. it's composition: S-PRG (Surface Pre-Reacted Glass) Fillers, UDMA (Urethane Dimethacrylate), TEGDMA (Triethylene Glycol Dimethacrylate), Micro Fumed Silica.
| Study group | Role | What they receive |
|---|---|---|
| Fisseal, Resin based fissure sealant | Active comparator | Fisseal is a light-curing, fluoride-releasing pit and fissure sealant. the occlusal surfaces will be etched with 37% phosphoric acid for 30 seconds, rinsed with air-water spray for 30 s and dried with air for 15 s. resin sealant (Fisseal) then applied into the occlusal fissures and light-cured for 20 s. Receives: Other: Giomer based fissure sealant ( Beautisealant) |
| Beautisealant, Giomer based fissure sealant | Active comparator | Beautisealant is a fluoride-releasing pit and fissure sealant that features Giomer technology. the self-etch primer (BeautiSealant Primer) will be applied to the occlusal fissures with a fine micro brush. After waiting for 5 s, and homogenizing the bond layer with gentle air stream for 5 s, the giomer sealant (BeautiSealant Paste) will be placed and light-cured for 20 s. Receives: Other: Resin based fissure sealant (Fisseal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical success of giomer and conventional resin-based sealants applied on first permanent molars (FPMs) affected by MIH.
Measured: 12 months
number of tooth with failed fissure sealant
Fissure sealants will be checked under artificial light with a dental mirror and straight explorer. The sealants that will receive "Alpha" or "Bravo" scores from all of the USPHS Criteria (anatomic form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries) will be classified as successful. On the other hand, "Charlie" score from one or more of the USPHS criteria will be considered as a failure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start29 Jun 2025
- Primary completion29 Jun 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Hypomineralization, IncisorStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Centre, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Mahmoud Abd Elhakam, National Research Centre, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732790
- Sponsor's protocol ID
- 0345
- Acronym
- MIH RCT
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Resin Based Versus Giomer Fissure Sealants on MIH Affected Permanent Molars (RCT)
- ClinicalTrials.gov ID
- NCT07732790
- Acronym / sponsor ID
- MIH RCT / 0345
- Keywords
- MIH, resin based sealer, giomer based sealer, first permanent molar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Research Centre, EgyptUniversity, hospital or other
- Study start
- 29 Jun 2025 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 29 Jul 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 compare the effect of two types of fissure sealant a resin based and giomer based in molar incisor hypominerlisation first permanent molars
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fisseal, Resin based fissure sealant | Active comparator | Other: Giomer based fissure sealant ( Beautisealant)Fisseal is a light-curing, fluoride-releasing pit and fissure sealant. the occlusal surfaces will be etched with 37% phosphoric acid for 30 seconds, rinsed with air-water spray for 30 s and dried with air for 15 s. resin sealant (Fisseal) then applied into the occlusal fissures and light-cured for 20 s. |
| Beautisealant, Giomer based fissure sealant | Active comparator | Other: Resin based fissure sealant (Fisseal)Beautisealant is a fluoride-releasing pit and fissure sealant that features Giomer technology. the self-etch primer (BeautiSealant Primer) will be applied to the occlusal fissures with a fine micro brush. After waiting for 5 s, and homogenizing the bond layer with gentle air stream for 5 s, the giomer sealant (BeautiSealant Paste) will be placed and light-cured for 20 s. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Apparently Healthy Children aged 6-12 years having at least one fully erupted First Permanent Molar (FPM) with MIH indicated for non-invasive fissure sealant.
Key exclusion criteria (4 listed)
- Children having hypomineralized FPMs with post eruption breakdown (PEB).
- Cavitated carious lesions.
- Restorations, fixed orthodontic appliances.
- Enamel defect(s) due to a condition other than MIH.
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 |
|---|---|---|
| Resin based fissure sealant (Fisseal)Fisseal is a light-curing, fluoride-releasing pit and fissure sealant. composition: Methacrylate Monomers, Inorganic Fillers, Photoinitiator System and Sodium Fluoride. | Other | Beautisealant, Giomer based fissure sealant |
| Giomer based fissure sealant ( Beautisealant)BeautiSealant is a fluoride-releasing pit and fissure sealant that features Giomer technology. it's BPA- and HEMA-free pit and fissure sealant. it's composition: S-PRG (Surface Pre-Reacted Glass) Fillers, UDMA (Urethane Dimethacrylate), TEGDMA (Triethylene Glycol Dimethacrylate), Micro Fumed Silica. | Other | Fisseal, Resin based fissure sealant |
Primary outcome
Evaluate the clinical success of giomer and conventional resin-based sealants applied on first permanent molars (FPMs) affected by MIH.
Time frame: 12 months
number of tooth with failed fissure sealant
Time frame: 12 months
Fissure sealants will be checked under artificial light with a dental mirror and straight explorer. The sealants that will receive "Alpha" or "Bravo" scores from all of the USPHS Criteria (anatomic form, marginal adaptation, surface texture, marginal discoloration, retention and secondary caries) will be classified as successful. On the other hand, "Charlie" score from one or more of the USPHS criteria will be considered as a failure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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 Resin based fissure sealant (Fisseal) and Giomer based fissure sealant ( Beautisealant) in people with Molar Hypomineralization, Incisor and Fissure Sealant, run by National Research Centre, Egypt at 1 site in Egypt.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 29 Jul 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the clinical success of giomer and conventional resin-based sealants applied on first permanent molars (FPMs) affected by MIH. (time frame: 12 months). 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 29 Jul 2026.