Oral Health Related Quality of Life of Children With Amelogenesis Imperfecta

NCT07250906 | Recruiting

• 1 other identifier: 2025/129
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Amelogenesis Imperfecta

Keywords

quality of life; CPQ11-14

Outcome Measures

Primary Outcomes (1)

• oral health related quality of life

  CPQ11-14

  3 months

Secondary Outcomes (7)

• self esteem

  3 months

• psychosocial impact of dental aesthetics

  3 months

• hypersensitivity

  3 months

• oral hygiene

  3 months

• gingival health

  3 months

Interventions

Veneers PROCEDURE

Anterior veneer treatment

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with amelogenesis imperfecta

You may qualify if:

• Systemically healthy,
• Aged between 11 and 14,
• Diagnosed with Amelogenesis Imperfecta,
• Need for anterior veneers,
• Both female and male volunteers

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University, Faculty of Dentistry, Department of Pedodontics

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Amelogenesis Imperfecta

Interventions

Dental Veneers

Condition Hierarchy (Ancestors)

Developmental Defects of Enamel; Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assos. Prof.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 26, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): May 16, 2026
• Study Completion (Estimated): August 16, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)