Molar Incisor HypomineralizationNCT04369768
Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns
A study testing restoration of permanent molars affected with MIH in people with Molar Incisor Hypomineralization, run by Cairo University.
Trial summary
The aim of this study is to compare the clinical outcome of using direct esthetic composite restorations and the use of preformed metal crowns in managing MIH cases among a group of Egyptian children. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- restoration of permanent molars affected with MIH
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Aug 2021
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with MIH in one fully erupted molar or more.
- Age ranging from 7-12 years.
- Cooperative children
- Good general health.
Who cannot join
- patients participating in other experiments.
- Patients with parents planning to move away within the following year.
- Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
- MIH-affected molars that have a very poor prognosis and require extraction.
- First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial (Part I)
The aim of this study is to compare the clinical outcome of using direct esthetic composite restorations and the use of preformed metal crowns in managing MIH cases among a group of Egyptian children.
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- restoration of permanent molars affected with MIH
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
restoration of permanent molars affected with MIHProcedure or surgery
restore MIH affected molars using direct composite or preformed metal crowns
| Study group | Role | What they receive |
|---|---|---|
| direct composite restorations | Active comparator | Not described Receives: Procedure: restoration of permanent molars affected with MIH |
| preformed metal crowns | Active comparator | Not described Receives: Procedure: restoration of permanent molars affected with MIH |
What is being measured
The primary outcome is the main question the study is designed to answer.
treating hypersensitivity associated with MIH affected permanent molars by questioning the patient
questioning the patient about hypersensitivity after performing treatment ( direct composite restorations and preformed metal crowns)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study startJul 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionAug 2021 (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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Nasr Fares, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369768
- Sponsor's protocol ID
- MIH restoration
- Status last verified
- Jul 2020
- First submitted
- 28 Apr 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Permanent Molars Affected With Molar-incisor-hypomineralization (MIH) Among a Group of Egyptian Children Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial (Part I)
- ClinicalTrials.gov ID
- NCT04369768
- Acronym / sponsor ID
- MIH restoration
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 30 Apr 2020 (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 aim of this study is to compare the clinical outcome of using direct esthetic composite restorations and the use of preformed metal crowns in managing MIH cases among a group of Egyptian children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct composite restorations | Active comparator | Procedure: restoration of permanent molars affected with MIH |
| preformed metal crowns | Active comparator | Procedure: restoration of permanent molars affected with MIH |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with MIH in one fully erupted molar or more.
- Age ranging from 7-12 years.
- Cooperative children
- Good general health.
Key exclusion criteria (5 listed)
- patients participating in other experiments.
- Patients with parents planning to move away within the following year.
- Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
- MIH-affected molars that have a very poor prognosis and require extraction.
- First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta
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 |
|---|---|---|
| restoration of permanent molars affected with MIHrestore MIH affected molars using direct composite or preformed metal crowns | Procedure or surgery | direct composite restorations, preformed metal crowns |
Primary outcome
treating hypersensitivity associated with MIH affected permanent molars by questioning the patient
Time frame: one year
questioning the patient about hypersensitivity after performing treatment ( direct composite restorations and preformed metal crowns)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
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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 restoration of permanent molars affected with MIH 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 4 inclusion and 5 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 20 Jul 2020. 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 Sandra Nasr Fares (01225167030, dr.sandra.nasr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treating hypersensitivity associated with MIH affected permanent molars by questioning the patient (time frame: one year). 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 20 Jul 2020.