RecruitingNot Applicable

Oral Health Related Quality of Life of Children With Amelogenesis Imperfecta

Turkey (Türkiye)20 participantsStarted 2025-11-24

Plain-language 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. 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.

Who can participate

Age range

11 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Systemically healthy, * Aged between 11 and 14, * Diagnosed with Amelogenesis Imperfecta, * Need for anterior veneers, * Both female and male volunteers Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

oral health related quality of life

Timeframe: 1 month and 6 months

Trial details

NCT IDNCT07250906

SponsorIstanbul University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07-23

View on ClinicalTrials.gov More Amelogenesis Imperfecta trials