Molar Incisor HypomineralizationPhase 3NCT05542667
Comparative Evaluation of Giomer Varnish vs Fluoride Varnish as Desensitizing Agents in Teeth With MIH
A Phase 3 study testing Giomer varnish and Fluoride varnish in people with Molar Incisor Hypomineralization, run by Cairo University.
Trial summary
this clinical trial's aim is to compare two desensitizing agents available in the market to prove which one is more efficient in children with molar incisor hypomineralization complaining from hypersensitivity Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Giomer varnish and Fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to Aug 2026
- Phase
- Phase 3
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children :
- Patients aged between 8 and 10 years old with MIH affected teeth according to European Academy of Pediatric Dentistry diagnostic criteria (Lygidakis et al., 2022)
- Systemically healthy.
- Cooperative patients who will comply with follow-up visits.
- Teeth:
- At least one first molar or one incisor erupted in the oral cavity exhibiting molar incisor hypomineralization.
- Teeth representing molar incisor hypomineralization are sensitive.
- -
Who cannot join
- • Children:
- <!-- -->
- Undergoing desensitizing treatments in the last 3 months
- Occlusal problems such as bruxism.
- Cognition problems.
- Who used any type of analgesics before treatment.
Show all 10Show fewer
- Undergoing orthodontic treatment.
- Teeth:
- Enamel defects as enamel hypoplasia, amelogenesis imperfecta, and dental fluorosis.
- Carious teeth.
About this study
Official title: Comparative Evaluation of Giomer Varnish vs Fluoride Varnish as Desensitizing Agents Among a Group of Children With Molar Incisor Hypomineralization : A Controlled Clinical Trial
this clinical trial's aim is to compare two desensitizing agents available in the market to prove which one is more efficient in children with molar incisor hypomineralization complaining from hypersensitivity
Read the detailed description
Interventions
The principal investigator will carry out all treatment procedures, and the patients will be assigned.
For both interventions:
- Informed consent from participating parents.
- Baseline records photographs and personal data collection .
- Allocation (concealed by withdrawing a sealed opaque envelope containing eight times folded paper containing the type of desensitizing agent that will be used then writing the patient name and I.D. on it and will be opened in the first visit of treatment).
- Diagnostic chart with personal, medical, and dental history will be filled.
- Evaluation of oral health-related quality of life as a baseline, using the Arabic version of the child perception questionnaire-8-10m indicated for children from age 8 to 10 years old, it consists of 25 questions related to oral symptoms (5 questions), functional limitations ( 5 questions), emotional wellbeing (5 questions) and social wellbeing ( 10 questions), responses are made on an ordinal scale ( 0 = never, 1 = once/twice, 2= sometimes, 3= often, 4= every day/ almost every day).
- Teeth will be cleaned with prophylaxis paste using a low-speed contra brush then teeth will be inspected using a dental mirror and reflected light of the dental unit and the teeth must be moist during the clinical examination to assess the clinical inclusion criteria according to European Academy of Pediatric Dentistry diagnostic criteria.
- Preoperative, intraoperative, and Postoperative photographs will be taken.
- Prior to initiation of the treatment, all included teeth will be evaluated for pain in response to an evaporative stimulus using the triple syringe, the air is directed perpendicular to teeth and held at approximately 2 mm for 3 seconds and children are informed to raise their hands or fingers when any discomfort is felt and then the pain is evaluated using the Wong-Baker faces rating scale and Schiff scale.
- Teeth also are evaluated to thermal stimulus, using an anesthetic carpule refrigerated at 4c for at least 24 hours and the carpule is to be placed in contact with the tooth for 1 to 5 seconds according to child response and pain is to be evaluated as with evaporative stimulus.
- Application of rubber dam for isolation.
- Prior to treatment, teeth received prophylaxis using pumice paste, cleaned using the triple water syringe, and dried.
Children will then be allocated into either one of the groups alternatively depending on the desensitizing agent used as follows:
Group I (Experimental group) Giomer varnish. Group II (Control group) Fluoride varnish.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Giomer varnish, Fluoride varnish
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giomer varnishCombination product
- After dryness and isolation are accomplished, Giomer varnish ( PRG coat barrier, by Shofu) will be applied once at the first treatment visit, one drop of PRG Coat Barrier ACTIVE will be added to the container provided in the package containing PRG Coat Barrier BASE the materials will be mixed together with a disposable tip provided by the kit a thin layer is to be applied and left untouched for 3 seconds according to manufacturer instructions and finally varnish is to be light-cured.
Fluoride varnishCombination product
After dryness and isolation are accomplished, fluoride varnish (Biflourid 10, by Voco ) single-use type, the foil in the single-use Bifluorid 10 will be pierced using Micro-Tim brush, then a thin layer of the varnish is to be applied using a micro brush for four sessions at a frequency of one session each week, the varnish will be left undisturbed for 10-20 seconds then air-dried according to manufacturer instructions.
| Study group | Role | What they receive |
|---|---|---|
| Giomer varnish | Active comparator | PRG coat barrier by SHOFU is varnish based on a new technology named Giomer by incorporating pre-reacted glass ionomer particles, so varnish contains GI particles embedded in a resin matrix, it should be applied once per year since it is the only varnish in the market that is light cured so it is more durable than others. Receives: Combination Product: Giomer varnish |
| Fluoroide varnish | Active comparator | Bifluorid 10 by VOCO is a varnish containing 5% sodium fluoride and 5 % calcium fluoride, it should be applied once each 6 months by a professional dentist and it tends to decrease the hypersensitivity of the teeth as well as decrease the risk of caries. Receives: Combination Product: Fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of pain to the evaporative stimulus
will be measured using wong baker faces rating scale from 0 to 5 , 0 being the better outcome
Measured: 1 month
Absence of pain to the evaporative stimulus
will be measured using schiff scale from 0 to 3 , 0 being the better outcome
Measured: 1 month
Secondary outcomes (2)
Absence of pain to thermal stimulus
will be measured using wong baker faces rating scale from 0 to 5 , 0 being the better outcome
Measured: 1 month
Evaluation of oral health-related quality of life (OHRQoL)
measured using the Arabic child perception questionnaire from age 8-10 years old , contains 25 questions and each answer is rating from 0 to 4 , 0 being the better outcome
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study startFeb 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionAug 2026 (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 Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethar khaled hassan ahmed swidan, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542667
- Sponsor's protocol ID
- 8484
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol ,details about interventions , statistical methods used and results will all be shared with others.
Publications
Swidan EKH, Abbas HME, Shamy SHE. Comparative evaluation of Giomer varnish versus fluoride varnish as desensitizing agents among a group of children with molar incisor hypomineralization: a randomized clinical trial. BMC Oral Health. 2026 Sep 15;26(1):1741. doi: 10.1186/s12903-026-09760-y.
PubMed 42745265
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Giomer Varnish vs Fluoride Varnish as Desensitizing Agents Among a Group of Children With Molar Incisor Hypomineralization : A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05542667
- Acronym / sponsor ID
- 8484
- Conditions
- Molar Incisor Hypomineralization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 15 Sep 2022 (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 clinical trial's aim is to compare two desensitizing agents available in the market to prove which one is more efficient in children with molar incisor hypomineralization complaining from hypersensitivity
Detailed description
Interventions
The principal investigator will carry out all treatment procedures, and the patients will be assigned.
For both interventions:
- Informed consent from participating parents.
- Baseline records photographs and personal data collection .
- Allocation (concealed by withdrawing a sealed opaque envelope containing eight times folded paper containing the type of desensitizing agent that will be used then writing the patient name and I.D. on it and will be opened in the first visit of treatment).
- Diagnostic chart with personal, medical, and dental history will be filled.
- Evaluation of oral health-related quality of life as a baseline, using the Arabic version of the child perception questionnaire-8-10m indicated for children from age 8 to 10 years old, it consists of 25 questions related to oral symptoms (5 questions), functional limitations ( 5 questions), emotional wellbeing (5 questions) and social wellbeing ( 10 questions), responses are made on an ordinal scale ( 0 = never, 1 = once/twice, 2= sometimes, 3= often, 4= every day/ almost every day).
- Teeth will be cleaned with prophylaxis paste using a low-speed contra brush then teeth will be inspected using a dental mirror and reflected light of the dental unit and the teeth must be moist during the clinical examination to assess the clinical inclusion criteria according to European Academy of Pediatric Dentistry diagnostic criteria.
- Preoperative, intraoperative, and Postoperative photographs will be taken.
- Prior to initiation of the treatment, all included teeth will be evaluated for pain in response to an evaporative stimulus using the triple syringe, the air is directed perpendicular to teeth and held at approximately 2 mm for 3 seconds and children are informed to raise their hands or fingers when any discomfort is felt and then the pain is evaluated using the Wong-Baker faces rating scale and Schiff scale.
- Teeth also are evaluated to thermal stimulus, using an anesthetic carpule refrigerated at 4c for at least 24 hours and the carpule is to be placed in contact with the tooth for 1 to 5 seconds according to child response and pain is to be evaluated as with evaporative stimulus.
- Application of rubber dam for isolation.
- Prior to treatment, teeth received prophylaxis using pumice paste, cleaned using the triple water syringe, and dried.
Children will then be allocated into either one of the groups alternatively depending on the desensitizing agent used as follows:
Group I (Experimental group) Giomer varnish. Group II (Control group) Fluoride varnish.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Giomer varnish | Active comparator | Combination Product: Giomer varnishPRG coat barrier by SHOFU is varnish based on a new technology named Giomer by incorporating pre-reacted glass ionomer particles, so varnish contains GI particles embedded in a resin matrix, it should be applied once per year since it is the only varnish in the market that is light cured so it is more durable than others. |
| Fluoroide varnish | Active comparator | Combination Product: Fluoride varnishBifluorid 10 by VOCO is a varnish containing 5% sodium fluoride and 5 % calcium fluoride, it should be applied once each 6 months by a professional dentist and it tends to decrease the hypersensitivity of the teeth as well as decrease the risk of caries. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children :
- Teeth:
- -
Key exclusion criteria (10 listed)
- <!-- -->
- Teeth:
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 |
|---|---|---|
| Giomer varnish* After dryness and isolation are accomplished, Giomer varnish ( PRG coat barrier, by Shofu) will be applied once at the first treatment visit, one drop of PRG Coat Barrier ACTIVE will be added to the container provided in the package containing PRG Coat Barrier BASE the materials will be mixed together with a disposable tip provided by the kit a thin layer is to be applied and left untouched for 3 seconds according to manufacturer instructions and finally varnish is to be light-cured. | Combination product | Giomer varnish |
| Fluoride varnishAfter dryness and isolation are accomplished, fluoride varnish (Biflourid 10, by Voco ) single-use type, the foil in the single-use Bifluorid 10 will be pierced using Micro-Tim brush, then a thin layer of the varnish is to be applied using a micro brush for four sessions at a frequency of one session each week, the varnish will be left undisturbed for 10-20 seconds then air-dried according to manufacturer instructions. | Combination product | Fluoroide varnish |
Primary outcome
Absence of pain to the evaporative stimulus
Time frame: 1 month
will be measured using wong baker faces rating scale from 0 to 5 , 0 being the better outcome
Absence of pain to the evaporative stimulus
Time frame: 1 month
will be measured using schiff scale from 0 to 3 , 0 being the better outcome
2 secondary outcomes
Absence of pain to thermal stimulus
Time frame: 1 month
Evaluation of oral health-related quality of life (OHRQoL)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 42745265Swidan EKH, Abbas HME, Shamy SHE. Comparative evaluation of Giomer varnish versus fluoride varnish as desensitizing agents among a group of children with molar incisor hypomineralization: a randomized clinical trial. BMC Oral Health. 2026 Sep 15;26(1):1741. doi: 10.1186/s12903-026-09760-y.
- Individual participant dataSharing planned: Yes. study protocol ,details about interventions , statistical methods used and results will all be shared with others.
Related trials for Molar Incisor Hypomineralization
Active, not recruiting
Computer-aided Design/Computer-aided Manufacturing for Mild to Moderate Molar Incisor Hypomineralization Treatment
Molar Incisor Hypomineralization
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
Recruiting
Nanohydroxyapatite Versus Sodium Fluoride Varnish in Remineralizing MIH Anterior Teeth
Fluoride Varnishes, Molar Incisor Hypomineralisation
Recruiting
Molar-Incisor Hypomineralization and Resin Infiltration
Molar Incisor Hypomineralization
Active, not recruiting
Pain Assessment Governing Partial or Full Pulpotomy of Immature Molars With Irreversible Pulpitis in Molar Incisor Hypomineralization
Molar Incisor Hypomineralisation, Irreversible Pulpitis
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Giomer varnish and Fluoride varnish in people with Molar Incisor Hypomineralization, run by Cairo 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 8 inclusion and 10 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 1 Sep 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Absence of pain to the evaporative stimulus (time frame: 1 month). 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?
On the ClinicalTrials.gov record for NCT05542667, 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 1 Sep 2023.