Paediatric DentistryNCT05848388
Molar Incisor Malformation in Egypt
An observational study of Paediatric Dentistry, run by Fayoum University at 1 site in Egypt.
Trial summary
The aim of the current study is to assess the prevalence of molar incisor malformation in Fayoum-Egypt. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Paediatric Dentistry
- What is being tested?
- Molar incisor malformation presence
- How many people
- 5,630 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2022to 1 Mar 2023
- Phase
- Observational
- 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 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: panoramic radiographic images from a private dental radiology center in Fayoum Egypt
Who may be able to join
- Panoramic radiographs for older than nine-year-old patients, having completely developed first permanent molars
Who cannot join
- Panoramic radiographs with missing first permanent molars or pathological lesions which may cause root resorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevelance of Molar Incisor Malformation in Egypt
The aim of the current study is to assess the prevalence of molar incisor malformation in Fayoum-Egypt.
Read the detailed description
Localized developmental radicular dysplasia is a rare finding. This radicular formation arrest may be due to traumas, infections, radiation therapy, chemotherapy, or idiopathic.
Molar Incisor Malformation is a condition characterized by arrested or altered radicular development of first permanent molars. Roots may be thin, short, or totally missing. In some patients, there are constrictions located in the cervical part of the crown of the permanent incisors. There are also cases where the roots of the second primary molars are affected.
MIM could also have been mistaken for a consequence of severe root resorption, or dentine dysplasia prior to its initial description.
This unique deformity, regardless of its nomenclature, presents previously undescribed clinical features and it is quite difficult to get a successful conservative treatment result.
The aim of the current study is to assess the prevalence of this rare condition in Fayoum-Egypt.
- Conditions
- Paediatric Dentistry
- Being tested
- Molar incisor malformation presence
- Keywords
- molar-incisor malformation, developmental malformation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molar incisor malformation presenceOther
the presence of radiographic features of molar incisor malformation
| Study group | Role | What they receive |
|---|---|---|
| 1 | older than 9-year-old patients, with panoramic radiographic images showing the first permanent molars Receives: Other: Molar incisor malformation presence |
What is being measured
The primary outcome is the main question the study is designed to answer.
molar incisor malformation
the presence of root malformation to indicate the diagnosis of molar incisor malformation
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start30 May 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatric DentistryStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Moussa Azab, Fayoum University
- Investigators
- maha M azab, Principal investigator, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848388
- Sponsor's protocol ID
- Molar Incisor Malformation
- Status last verified
- Apr 2023
- First submitted
- 28 Apr 2023
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevelance of Molar Incisor Malformation in Egypt
- ClinicalTrials.gov ID
- NCT05848388
- Acronym / sponsor ID
- Molar Incisor Malformation
- Conditions
- Paediatric Dentistry
- Keywords
- molar-incisor malformation, developmental malformation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,630 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 8 May 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 aim of the current study is to assess the prevalence of molar incisor malformation in Fayoum-Egypt.
Detailed description
Localized developmental radicular dysplasia is a rare finding. This radicular formation arrest may be due to traumas, infections, radiation therapy, chemotherapy, or idiopathic.
Molar Incisor Malformation is a condition characterized by arrested or altered radicular development of first permanent molars. Roots may be thin, short, or totally missing. In some patients, there are constrictions located in the cervical part of the crown of the permanent incisors. There are also cases where the roots of the second primary molars are affected.
MIM could also have been mistaken for a consequence of severe root resorption, or dentine dysplasia prior to its initial description.
This unique deformity, regardless of its nomenclature, presents previously undescribed clinical features and it is quite difficult to get a successful conservative treatment result.
The aim of the current study is to assess the prevalence of this rare condition in Fayoum-Egypt.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Molar incisor malformation presenceolder than 9-year-old patients, with panoramic radiographic images showing the first permanent molars |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- panoramic radiographic images from a private dental radiology center in Fayoum Egypt
Key inclusion criteria (1 listed)
- Panoramic radiographs for older than nine-year-old patients, having completely developed first permanent molars
Key exclusion criteria (1 listed)
- Panoramic radiographs with missing first permanent molars or pathological lesions which may cause root resorption
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 |
|---|---|---|
| Molar incisor malformation presencethe presence of radiographic features of molar incisor malformation | Other | 1 |
Primary outcome
molar incisor malformation
Time frame: Day 1
the presence of root malformation to indicate the diagnosis of molar incisor malformation
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 8 May 2023.
Related trials for Paediatric Dentistry
Not yet recruiting
3D-Printed Resin Crowns Versus Bioflx Crowns in Primary Molars
Dental Restorations in Children, Pediatric Dentistry
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries
Not yet recruiting
Virtual Reality and Point-of-View Video Modeling for Dental Anxiety in Children
Dental Anxiety in Children
Active, not recruiting
Adapting the Sensory Environment to Reduce Stress in Children With Autism During Dental Visits
Autism, Autism Disorders and Maternal Stress
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
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.
maha M azab principal investigator
Fayoum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paediatric Dentistry, run by Fayoum 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 1 inclusion and 1 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 8 May 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.
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?
molar incisor malformation (time frame: Day 1). 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 8 May 2023.