Amelogenesis ImperfectaNCT07250906
Oral Health Related Quality of Life of Children With Amelogenesis Imperfecta
An observational study of Amelogenesis Imperfecta, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
This project aims to evaluate the impact of anterior veneer treatment on oral health-related quality of life in children with amelogenesis imperfecta (AI). AI is an inherited disorder that causes structural defects in enamel due to genetic abnormalities, leading to aesthetic, functional, and psychosocial challenges. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Amelogenesis Imperfecta
- What is being tested?
- Veneers
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Nov 2025to 2 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with amelogenesis imperfecta
Who may be able to join
- Systemically healthy,
- Aged between 11 and 14,
- Diagnosed with Amelogenesis Imperfecta,
- Need for anterior veneers,
- Both female and male volunteers
Who cannot join
- Those with systemic diseases,
- Those with a history of allergies,
- Those not diagnosed with Amelogenesis Imperfecta,
- Those without an indication for veneers,
- Those lacking adequate cooperation skills,
- Patients younger than 11 or older than 14 years will not be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University, Faculty of Dentistry, Department of Pedodontics
Istanbul
Yelda Kasımoğlu, Assoc. Prof., 00905336233978, yelda.kasimoglu@istanbul.edu.tr
About this study
Official title: Evaluation of the Impact of Anterior Veneers on the Quality of Life of Children With Amelogenesis Imperfecta
This project aims to evaluate the impact of anterior veneer treatment on oral health-related quality of life in children with amelogenesis imperfecta (AI). AI is an inherited disorder that causes structural defects in enamel due to genetic abnormalities, leading to aesthetic, functional, and psychosocial challenges. Enamel defects, particularly in the anterior teeth, negatively affect patients' self-confidence and social interactions. In this study, the short-term aesthetic, functional, and psychosocial effects of veneer restorations applied to children with AI will be assessed.
This research is designed as a single-center, prospective clinical study. The study population will include pediatric patients aged 11-14 years who have been clinically and radiographically diagnosed with AI at our faculty clinic. Participants' oral health-related quality of life will be evaluated before treatment and one month after treatment using the Child Perceptions Questionnaire (CPQ11-14). Psychosocial improvement will be measured using the Rosenberg Self-Esteem Scale and the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ), while aesthetic satisfaction will be assessed using a Visual Analogue Scale (VAS). In addition, to objectively evaluate the participants' oral hygiene and dental health, the plaque index, gingival index, bleeding on probing index, and DMFT index will be recorded.
The data obtained are expected to demonstrate the positive impact of veneer treatment on the quality of life of children with AI, emphasizing the importance of early aesthetic rehabilitation in pediatric patients. In this respect, the study aims to provide a novel clinical and psychosocial contribution to the existing literature on the management of AI in pediatric dentistry.
- Conditions
- Amelogenesis Imperfecta
- Being tested
- Veneers
- Keywords
- quality of life, CPQ11-14
- Medical subject headings
- Amelogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeneersProcedure or surgery
Anterior veneer treatment
| Study group | Role | What they receive |
|---|---|---|
| Case | Children with amelogenesis imperfecta Receives: Procedure: Veneers | |
| Control | Children with healthy teeth and periodontium |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral health related quality of life
CPQ11-14
Measured: 1 month and 6 months
Secondary outcomes (7)
self esteem
Rosenberg Self-Esteem Scale
Measured: 1 month and 6 months
psychosocial impact of dental aesthetics
PIDAQ
Measured: 1 month and 6 months
hypersensitivity
Wong-Baker scale
Measured: 3 months
oral hygiene
plaque index
Measured: 3 months
gingival health
gingival index
Measured: 3 months
gingival bleeding
bleeding on probing
Measured: 1 month and 6 months
caries status
DMFT
Measured: 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start24 Nov 2025
- Primary completion2 Sep 2026
- Study completion2 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amelogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by Istanbul 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yelda Kasımoğlu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250906
- Sponsor's protocol ID
- 2025/129
- Status last verified
- Sep 2026
- First submitted
- 19 Nov 2025
- Last updated
- 3 Sep 2026
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Anterior Veneers on the Quality of Life of Children With Amelogenesis Imperfecta
- ClinicalTrials.gov ID
- NCT07250906
- Acronym / sponsor ID
- 2025/129
- Conditions
- Amelogenesis Imperfecta
- Keywords
- quality of life, CPQ11-14
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 2 Oct 2026 (estimated)
- First posted
- 26 Nov 2025 (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.
This project aims to evaluate the impact of anterior veneer treatment on oral health-related quality of life in children with amelogenesis imperfecta (AI). AI is an inherited disorder that causes structural defects in enamel due to genetic abnormalities, leading to aesthetic, functional, and psychosocial challenges. Enamel defects, particularly in the anterior teeth, negatively affect patients' self-confidence and social interactions. In this study, the short-term aesthetic, functional, and psychosocial effects of veneer restorations applied to children with AI will be assessed.
This research is designed as a single-center, prospective clinical study. The study population will include pediatric patients aged 11-14 years who have been clinically and radiographically diagnosed with AI at our faculty clinic. Participants' oral health-related quality of life will be evaluated before treatment and one month after treatment using the Child Perceptions Questionnaire (CPQ11-14). Psychosocial improvement will be measured using the Rosenberg Self-Esteem Scale and the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ), while aesthetic satisfaction will be assessed using a Visual Analogue Scale (VAS). In addition, to objectively evaluate the participants' oral hygiene and dental health, the plaque index, gingival index, bleeding on probing index, and DMFT index will be recorded.
The data obtained are expected to demonstrate the positive impact of veneer treatment on the quality of life of children with AI, emphasizing the importance of early aesthetic rehabilitation in pediatric patients. In this respect, the study aims to provide a novel clinical and psychosocial contribution to the existing literature on the management of AI in pediatric dentistry.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Procedure: VeneersChildren with amelogenesis imperfecta |
| Control | – | –Children with healthy teeth and periodontium |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with amelogenesis imperfecta
Key inclusion criteria (5 listed)
- Systemically healthy,
- Aged between 11 and 14,
- Diagnosed with Amelogenesis Imperfecta,
- Need for anterior veneers,
- Both female and male volunteers
Key exclusion criteria (6 listed)
- Those with systemic diseases,
- Those with a history of allergies,
- Those not diagnosed with Amelogenesis Imperfecta,
- Those without an indication for veneers,
- Those lacking adequate cooperation skills,
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 |
|---|---|---|
| VeneersAnterior veneer treatment | Procedure or surgery | Case |
Primary outcome
oral health related quality of life
Time frame: 1 month and 6 months
CPQ11-14
7 secondary outcomes
self esteem
Time frame: 1 month and 6 months
psychosocial impact of dental aesthetics
Time frame: 1 month and 6 months
hypersensitivity
Time frame: 3 months
oral hygiene
Time frame: 3 months
gingival health
Time frame: 3 months
gingival bleeding
Time frame: 1 month and 6 months
caries status
Time frame: 1 month and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Amelogenesis Imperfecta
Not yet recruiting
Renal and Vascular Phenotypic Characterization of Patients With Enamel Renal Syndrome Due to a Pathogenic Variant of the FAM20A Gene and Pathophysiological Study of Ectopic Calcifications
Enamel Renal Syndrome
RecruitingObservational study
Colorimetric, Ultra-structural and Elemental Comparison of Dental Enamel Defects
Amelogenesis Imperfecta, Dental Fluoroses
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.
Istanbul University, Faculty of Dentistry, Department of Pedodontics
Istanbul, Turkey (Türkiye)
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 Amelogenesis Imperfecta, run by Istanbul University 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 3 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral health related quality of life (time frame: 1 month and 6 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 3 Sep 2026.