Molar Incisor HypomineralizationNCT05779332
Prevalence, Etiology and Effects on Oral Health and Life Quality of Molar Incisor Hypomineralization
An observational study of Molar Incisor Hypomineralization and Oral Health, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL). Read more about this study
- Who is it for?
- Ages 9 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralization, Oral Health, Child, Only
- What is being tested?
- survey application
- Type of treatment
- Pill or oral medicine
- How many people
- 655 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2020to 15 Jun 2020
- 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 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 9-year-old children who were enrolled in the primary schools in the city of Rize, Turkey.
Who may be able to join
- Being 9-year-old,
- Mentally and physically capable of completing the questionnaire,
- Presence of fully erupted 4 permanent molars and 8 permanent incisors.
Who cannot join
- Children were receiving orthodontic treatment during the examination,
- Children had enamel hypoplasia or developmental defects,
- Children had amelogenesis imperfecta or dental fluorosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence, Etiology and Effects on Oral Health and Life Quality of Molar Incisor Hypomineralization: A Comprehensive Study
Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL).
Read the detailed description
Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL). The aim of this study was to determine the prevalence, etiology and impacts of MIH on oral health status and OHRQoL.
Six hundred and fifty-five parents and their children aged 9 years were included in the study. After parents completed the questionnaire about the etiology of MIH, children's OHRQoL was measured by the Child Perceptions Questionnaire (CPQ8-10). Children were evaluated for presence and severity of MIH, dental caries experience and oral hygiene status. Qualitative data were analyzed with the Pearson chi-square and Fisher's exact tests. For the quantitative data, if the normal distribution was not satisfied, Kruskal Wallis/Mann-Whitney U tests were used. Also, Binominal logistic regression analysis was performed and p<0.05 was statistical significant.
.
- Conditions
- Molar Incisor Hypomineralization, Oral Health, Child, Only, Pediatric ALL, Dental Caries, Dental Plaque
- Being tested
- survey application
- Keywords
- Molar Incisor Hypomineralization, oral health, MIH, Oral health related lif quality, Child Perceptions Questionnaire, OHRQoL, CPQ
- Medical subject headings
- Molar Hypomineralization, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Dental Caries, Dental Plaque, Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey applicationOther
Also called oral examination
Children's OHRQoL was measured by the Child Perceptions Questionnaire (CPQ8-10). Oral examination of children were conducted for presence and severity of MIH, dental caries experience and oral hygiene status.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence and etiology of MIH.
A questionnaire was applied to the parents about the etiological factors and the prevalence of MIH was determined by oral examination.
Measured: up to four months
To evaluate the impacts of MIH on oral health status.
Oral health was evaluated by recording dmft (decayed, missing and filled teeth) and plaque index values.
Measured: up to six months
To evaluate the impacts of MIH on OHRQoL.
The impact of MIH on quality of life (OHRQoL) was measured with the Child Perception Questionnaire (CPQ8-10).
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Feb 2020
- Primary completion30 Apr 2020
- Study completion15 Jun 2020
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.
- 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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 655 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sema Aydınoglu, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779332
- Sponsor's protocol ID
- 140
- Status last verified
- Mar 2023
- First submitted
- 19 Jan 2023
- Last updated
- 22 Mar 2023
- Results posted
- 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Etiology and Effects on Oral Health and Life Quality of Molar Incisor Hypomineralization: A Comprehensive Study
- ClinicalTrials.gov ID
- NCT05779332
- Acronym / sponsor ID
- 140
- Conditions
- Molar Incisor Hypomineralization, Oral Health, Child, Only, Pediatric ALL, Dental Caries, Dental Plaque
- Keywords
- Molar Incisor Hypomineralization, oral health, MIH, Oral health related lif quality, Child Perceptions Questionnaire, OHRQoL, CPQ
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 655 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 22 Mar 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.
Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL).
Detailed description
Molar incisor hypomineralization (MIH) can lead to many clinical conditions and affect oral health-related quality of life (OHRQoL). The aim of this study was to determine the prevalence, etiology and impacts of MIH on oral health status and OHRQoL.
Six hundred and fifty-five parents and their children aged 9 years were included in the study. After parents completed the questionnaire about the etiology of MIH, children's OHRQoL was measured by the Child Perceptions Questionnaire (CPQ8-10). Children were evaluated for presence and severity of MIH, dental caries experience and oral hygiene status. Qualitative data were analyzed with the Pearson chi-square and Fisher's exact tests. For the quantitative data, if the normal distribution was not satisfied, Kruskal Wallis/Mann-Whitney U tests were used. Also, Binominal logistic regression analysis was performed and p<0.05 was statistical significant.
.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 9 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 9-year-old children who were enrolled in the primary schools in the city of Rize, Turkey.
Key inclusion criteria (3 listed)
- Being 9-year-old,
- Mentally and physically capable of completing the questionnaire,
- Presence of fully erupted 4 permanent molars and 8 permanent incisors.
Key exclusion criteria (3 listed)
- Children were receiving orthodontic treatment during the examination,
- Children had enamel hypoplasia or developmental defects,
- Children had amelogenesis imperfecta or dental fluorosis.
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 |
|---|---|---|
| survey applicationAlso: oral examinationChildren's OHRQoL was measured by the Child Perceptions Questionnaire (CPQ8-10). Oral examination of children were conducted for presence and severity of MIH, dental caries experience and oral hygiene status. | Other | – |
Primary outcome
To determine the prevalence and etiology of MIH.
Time frame: up to four months
A questionnaire was applied to the parents about the etiological factors and the prevalence of MIH was determined by oral examination.
To evaluate the impacts of MIH on oral health status.
Time frame: up to six months
Oral health was evaluated by recording dmft (decayed, missing and filled teeth) and plaque index values.
To evaluate the impacts of MIH on OHRQoL.
Time frame: up to six months
The impact of MIH on quality of life (OHRQoL) was measured with the Child Perception Questionnaire (CPQ8-10).
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 22 Mar 2023.
- Individual participant dataSharing planned: No
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.
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 Molar Incisor Hypomineralization and Oral Health, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 22 Mar 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 Turkey (Türkiye). 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?
To determine the prevalence and etiology of MIH. (time frame: up to four months). The study lists 3 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 22 Mar 2023.