Molar Incisor HypomineralizationNCT04475419
Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization
A study testing preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe) in people with Molar Incisor Hypomineralization, run by Cairo University.
Trial summary
Restoration quality of molars affected by MIH using two different types of restorations direct composite and preformed crowns Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Dec 2020
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- .Children with molar incisor hypo mineralization 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 Quality in Molars Affected by Molar-incisor-hypomineralization Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial.
Restoration quality of molars affected by MIH using two different types of restorations direct composite and preformed crowns
Read the detailed description
MIH or molar incisor hypomineralization is one of the difficult clinical situations to be managed by dentists the aim of this study is to specify which is the better treatment among composite restorations and preformed crowns in terms of gingival health patient satisfaction pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future retreatment
- Conditions
- Molar Incisor Hypomineralization
- Being tested
- preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)Procedure or surgery
covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
| Study group | Role | What they receive |
|---|---|---|
| Direct composite restorations | Active comparator | bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe) Receives: Procedure: preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe) |
| preformed metal crowns | Active comparator | preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe) Receives: Procedure: preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain after the restoration .Binary (yes or No)
questionnaire
Measured: 12 MONTHS
Secondary outcomes (3)
Acceptability of the treatment Binary (yes or No)
questionnaire
Measured: 12 months
restoration quality Score index
(FDI criteria; criterion marginal adaptation)
Measured: 12 months
health-related quality of life changes by the therapies
measured as difference in Child Perceptions Questionnaire CPQ 8-10/11-14)
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 posted17 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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
- Model description
- parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud mohamed hassan, Cairo University
- Investigators
- manalf M elshiekh, MASTER, Study chair, CU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475419
- Sponsor's protocol ID
- 01008322329
- Status last verified
- Jul 2020
- First submitted
- 31 Jul 2019
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration Quality in Molars Affected by Molar-incisor-hypomineralization Using Composite Restorations or Preformed Metal Crowns: Two-arm Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04475419
- Acronym / sponsor ID
- 01008322329
- Conditions
- Molar Incisor Hypomineralization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Jul 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.
Restoration quality of molars affected by MIH using two different types of restorations direct composite and preformed crowns
Detailed description
MIH or molar incisor hypomineralization is one of the difficult clinical situations to be managed by dentists the aim of this study is to specify which is the better treatment among composite restorations and preformed crowns in terms of gingival health patient satisfaction pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future retreatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel groups
| Arm | Type | Receives |
|---|---|---|
| Direct composite restorations | Active comparator | Procedure: preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe) |
| preformed metal crowns | Active comparator | Procedure: preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe) |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- .Children with molar incisor hypo mineralization in one fully erupted molar or more.
- Age ranging from 7-12 years.
- Cooperative children
- Good general health
Key exclusion criteria (4 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 |
|---|---|---|
| preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe) | Procedure or surgery | Direct composite restorations, preformed metal crowns |
Primary outcome
pain after the restoration .Binary (yes or No)
Time frame: 12 MONTHS
questionnaire
3 secondary outcomes
Acceptability of the treatment Binary (yes or No)
Time frame: 12 months
restoration quality Score index
Time frame: 12 months
health-related quality of life changes by the therapies
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- 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.
manalf M elshiekh, MASTER study chair
CU
Questions about this trial
What is this clinical trial studying?
A study testing preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe) 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 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: status not confirmed, as of the sponsor's last update on 17 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 Eman m elmasry, PHD (01001651946 ext. 12345, Mahmoued_dentist3@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain after the restoration .Binary (yes or No) (time frame: 12 MONTHS). 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 17 Jul 2020.