Molar Incisor HypomineralizationPhase 4NCT06135272
Evaluation of Three Different Minimally Invasive Techniques for Management of Enamel Opacities in Patients With Molar Incisor Hypomineralization "Randomized Controlled Clinical Trial"
A Phase 4 study testing Resin infiltration, Resin modified glass ionomer varnish and Light cured giomer varnish in people with Molar Incisor Hypomineralization, run by Ain Shams University at 1 site in Egypt.
Trial summary
The controlled clinical trial will be done to evaluate Resin infiltration, Resin modified glass ionomer varnish and Light cured giomer varnish as minimally invasive techniques for management of enamel opacities of patients with molar incisor hypomineralization. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Resin infiltration, Resin modified glass ionomer varnish and Light cured giomer varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2023to 1 Aug 2025
- Phase
- Phase 4
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient with molar incisor hypomineralization having at least one incisor and/or molar mildly affected.
- Patient's age ranges from 6 to 10 years old.
- The affected tooth has demarcated opacity without post eruptive enamel breakdown.
- No cavitated lesion is related to the defect or previous restorative or preventive treatment.
- The tooth is free from any symptoms of irreversible pulp inflammation.
Who cannot join
- Children who are physically or mentally disabled or having any medical condition that will affect or complicate the treatment.
- Incisors previously subjected to trauma that might lead to loss of tooth structure or compromised the pulp vitality.
- Loss of tooth structure due to caries.
Trial locations and contacts
1 site in 1 country.
About this study
The controlled clinical trial will be done to evaluate Resin infiltration, Resin modified glass ionomer varnish and Light cured giomer varnish as minimally invasive techniques for management of enamel opacities of patients with molar incisor hypomineralization. Variation in mineral density of the enamel opacity , ,Hypersensitivity, Color change of the enamel opacity, Quality of life of the patient, Parent Satisfaction will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.
Read the detailed description
A total of 75 patients will be selected according to the eligibility criteria from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain Shams University.
A Full detailed medical and dental history will be obtained from the parent and a clinical examination will be performed using a dental mirror and a dental explorer under LED illumination and after dryness of the teeth to make sure that the patients fulfill the inclusion criteria.
After explaining the aim of the study, benefits, possible risks and rights to the patients and their parents. A signed informed consent of the parents as well as child's assent, outlined by the Ethical Committee, Faculty of Dentistry, Ain Shams University will be obtained prior to the conduction of the study. • The patients will be randomly equally allocated into three treatment groups (25 patients/ group): Group (A): patients will receive resin infiltration. Group (B): patients will receive resin modified glass ionomer varnish. Group (C): patients will receive a light cured giomer varnish.
Pre-operative procedures:
- Patients will be interviewed the oral health related quality of life questionnaire and it will be assessed prior treatment.
- Mineral density of the tooth will be measured using laser fluorescence.
- Teeth will be tested for sensitivity using recent validated test.
- Tooth color will be measured using vita easy shade.
Clinical procedures
- All teeth will be cleaned using prophylaxis paste and brush.
Group A:
- Local anesthesia administration and rubber dam isolation.
- Application of 15% hydrochloric acid gel (Icon etch) on affected enamel for two minutes and it will be washed for 30 seconds.
- Application of 99% ethanol (Icon dry) for 30 seconds then it will be dried using air-water tip.
- Application of Icon resin on the affected enamel surface and it will be left for three minutes to allow penetration.
- The resin will be light cured for 40 seconds then the excess will be removed.
- The Icon resin will be reapplied for one minute then light cured for 40 seconds.
- The tooth will be polished using composite polishing discs.
Group B:
- Application of 37% phosphoric acid gel on affected enamel for 15 seconds then rinse and dry for five seconds.
- The material will be dispensed and mixed for 15 seconds.
- The material will be applied to the affected tooth surface and light cured for 20 seconds.
- The excess will be removed using a moist cotton.
Group C:
- One drop of the active of the material will be mixed with one container of the base using a disposable brush.
- A thin layer of the mixture will be applied on the affected enamel surface after drying and it will be left undistributed for three seconds
- The material will be light cured for 10 seconds.
- The patients will be counselled to follow a proper diet and instructed about oral hygiene measures using soft tooth brush and fluoridated tooth paste twice daily.
- All patients will be scheduled to receive dental treatment for other dental findings at the Department of Pediatric Dentistry, Faculty of Dentistry, Ain Shams University.
The patient will be followed at 1, 3,6,12 and 18 months for evaluation of:
- Mineral density of the opacity
- Hypersensitivity
- Color change of the opacity
- Quality of life of the patient
- Parent Satisfaction
Statistical Analysis All data will be tabulated, summarized and statistically analyzed using software SPSS (Statistical Packages for Social Sciences).
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- Resin infiltration, Resin modified glass ionomer varnish, Light cured giomer varnish
- Keywords
- MIH, Molar Incisor Hypomineralization, enamel opacities, giomer varnish, ICON, Resin infiltration, Clinpro xt, resin modified glass ionomer varnish
- Medical subject headings
- Molar Hypomineralization, enamel opacities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resin infiltrationDrug
Icon Resin Infiltration as minimally invasive technique
Resin modified glass ionomer varnishDrug
Resin modified glass ionomer varnish as minimally invasive technique
Light cured giomer varnishDrug
Light cured giomer varnish as minimally invasive technique
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Resin infiltration Receives: Drug: Resin infiltration |
| Group B | Experimental | Resin modified glass ionomer varnish Receives: Drug: Resin modified glass ionomer varnish |
| Group C | Experimental | Light cured giomer varnish Receives: Drug: Light cured giomer varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in mineral density
Variation in mineral density of the enamel opacity using laser fluorescence.
Measured: It will be evaluated preoperatively and at 1, 3,6,12 and 18 months follow up.
Hypersensitivity
Hypersensitivity using VAS scale
Measured: It will be evaluated pre operative and at 1, 3,6,12 and 18 months follow up.
Secondary outcomes (3)
Color change of the enamel opacity
Color change of the enamel opacity using Vita easy shade
Measured: It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.
Quality of life of the patient
Quality of life of the patient using Child Perceptions Questionnaire (CPQ)
Measured: It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.
Parent Satisfaction
Parent Satisfaction using Parental-Caregivers Perceptions Questionnaire (P- CPQ )
Measured: It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Aug 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 Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- October University for Modern Sciences and Arts
- Responsible party
- Principal investigator, Hagar Mahmoud Mohie, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135272
- Sponsor's protocol ID
- PED23-4D
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 18 Nov 2023
- 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Three Different Minimally Invasive Techniques for Management of Enamel Opacities in Patients With Molar Incisor Hypomineralization "Randomized Controlled Clinical Trial"
- ClinicalTrials.gov ID
- NCT06135272
- Acronym / sponsor ID
- PED23-4D
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- MIH, Molar Incisor Hypomineralization, enamel opacities, giomer varnish, ICON, Resin infiltration, Clinpro xt, resin modified glass ionomer varnish
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- October University for Modern Sciences and Arts
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 18 Nov 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.
The controlled clinical trial will be done to evaluate Resin infiltration, Resin modified glass ionomer varnish and Light cured giomer varnish as minimally invasive techniques for management of enamel opacities of patients with molar incisor hypomineralization. Variation in mineral density of the enamel opacity , ,Hypersensitivity, Color change of the enamel opacity, Quality of life of the patient, Parent Satisfaction will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.
Detailed description
A total of 75 patients will be selected according to the eligibility criteria from the Pediatric Dentistry and Dental Public Health outpatient clinic, Faculty of Dentistry, Ain Shams University.
A Full detailed medical and dental history will be obtained from the parent and a clinical examination will be performed using a dental mirror and a dental explorer under LED illumination and after dryness of the teeth to make sure that the patients fulfill the inclusion criteria.
After explaining the aim of the study, benefits, possible risks and rights to the patients and their parents. A signed informed consent of the parents as well as child's assent, outlined by the Ethical Committee, Faculty of Dentistry, Ain Shams University will be obtained prior to the conduction of the study. • The patients will be randomly equally allocated into three treatment groups (25 patients/ group): Group (A): patients will receive resin infiltration. Group (B): patients will receive resin modified glass ionomer varnish. Group (C): patients will receive a light cured giomer varnish.
Pre-operative procedures:
- Patients will be interviewed the oral health related quality of life questionnaire and it will be assessed prior treatment.
- Mineral density of the tooth will be measured using laser fluorescence.
- Teeth will be tested for sensitivity using recent validated test.
- Tooth color will be measured using vita easy shade.
Clinical procedures
- All teeth will be cleaned using prophylaxis paste and brush.
Group A:
- Local anesthesia administration and rubber dam isolation.
- Application of 15% hydrochloric acid gel (Icon etch) on affected enamel for two minutes and it will be washed for 30 seconds.
- Application of 99% ethanol (Icon dry) for 30 seconds then it will be dried using air-water tip.
- Application of Icon resin on the affected enamel surface and it will be left for three minutes to allow penetration.
- The resin will be light cured for 40 seconds then the excess will be removed.
- The Icon resin will be reapplied for one minute then light cured for 40 seconds.
- The tooth will be polished using composite polishing discs.
Group B:
- Application of 37% phosphoric acid gel on affected enamel for 15 seconds then rinse and dry for five seconds.
- The material will be dispensed and mixed for 15 seconds.
- The material will be applied to the affected tooth surface and light cured for 20 seconds.
- The excess will be removed using a moist cotton.
Group C:
- One drop of the active of the material will be mixed with one container of the base using a disposable brush.
- A thin layer of the mixture will be applied on the affected enamel surface after drying and it will be left undistributed for three seconds
- The material will be light cured for 10 seconds.
- The patients will be counselled to follow a proper diet and instructed about oral hygiene measures using soft tooth brush and fluoridated tooth paste twice daily.
- All patients will be scheduled to receive dental treatment for other dental findings at the Department of Pediatric Dentistry, Faculty of Dentistry, Ain Shams University.
The patient will be followed at 1, 3,6,12 and 18 months for evaluation of:
- Mineral density of the opacity
- Hypersensitivity
- Color change of the opacity
- Quality of life of the patient
- Parent Satisfaction
Statistical Analysis All data will be tabulated, summarized and statistically analyzed using software SPSS (Statistical Packages for Social Sciences).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Resin infiltrationResin infiltration |
| Group B | Experimental | Drug: Resin modified glass ionomer varnishResin modified glass ionomer varnish |
| Group C | Experimental | Drug: Light cured giomer varnishLight cured giomer varnish |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patient with molar incisor hypomineralization having at least one incisor and/or molar mildly affected.
- Patient's age ranges from 6 to 10 years old.
- The affected tooth has demarcated opacity without post eruptive enamel breakdown.
- No cavitated lesion is related to the defect or previous restorative or preventive treatment.
- The tooth is free from any symptoms of irreversible pulp inflammation.
Key exclusion criteria (3 listed)
- Children who are physically or mentally disabled or having any medical condition that will affect or complicate the treatment.
- Incisors previously subjected to trauma that might lead to loss of tooth structure or compromised the pulp vitality.
- Loss of tooth structure due to caries.
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 infiltrationIcon Resin Infiltration as minimally invasive technique | Drug | Group A |
| Resin modified glass ionomer varnishResin modified glass ionomer varnish as minimally invasive technique | Drug | Group B |
| Light cured giomer varnishLight cured giomer varnish as minimally invasive technique | Drug | Group C |
Primary outcome
Variation in mineral density
Time frame: It will be evaluated preoperatively and at 1, 3,6,12 and 18 months follow up.
Variation in mineral density of the enamel opacity using laser fluorescence.
Hypersensitivity
Time frame: It will be evaluated pre operative and at 1, 3,6,12 and 18 months follow up.
Hypersensitivity using VAS scale
3 secondary outcomes
Color change of the enamel opacity
Time frame: It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.
Quality of life of the patient
Time frame: It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.
Parent Satisfaction
Time frame: It will be evaluated preoperatively and at 1, 3,6,12 and 18 months of follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Resin infiltration, Resin modified glass ionomer varnish and Light cured giomer varnish in people with Molar Incisor Hypomineralization, run by Ain Shams University 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 5 inclusion and 3 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 18 Nov 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Hagar M Mohie (0020100509369, hmohie@msa.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in mineral density (time frame: It will be evaluated preoperatively and at 1, 3,6,12 and 18 months follow up.). 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 18 Nov 2023.