Oral Health Related Quality of Life of Children With Amelogenesis Imperfecta

NCT ID: NCT07250906

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-16

Study Completion Date

2026-08-16

Brief Summary

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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.

Detailed Description

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Conditions

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Amelogenesis Imperfecta

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Veneers

Anterior veneer treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Yelda Kasımoğlu

Assos. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istanbul University, Faculty of Dentistry, Department of Pedodontics

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2025/129

Identifier Type: -

Identifier Source: org_study_id