- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07250906
Oral Health Related Quality of Life of Children With Amelogenesis Imperfecta
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.
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Recruiting
- Istanbul University, Faculty of Dentistry, Department of Pedodontics
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Contact:
- Yelda Kasımoğlu, Assoc. Prof.
- Phone Number: 00905336233978
- Email: yelda.kasimoglu@istanbul.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Case
Children with amelogenesis imperfecta
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Anterior veneer treatment
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Control
Children with healthy teeth and periodontium
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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oral health related quality of life
Time Frame: 1 month and 6 months
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CPQ11-14
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1 month and 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
hypersensitivity
Time Frame: 3 months
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Wong-Baker scale
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3 months
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oral hygiene
Time Frame: 3 months
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plaque index
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3 months
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gingival health
Time Frame: 3 months
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gingival index
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3 months
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self esteem
Time Frame: 1 month and 6 months
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Rosenberg Self-Esteem Scale
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1 month and 6 months
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psychosocial impact of dental aesthetics
Time Frame: 1 month and 6 months
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PIDAQ
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1 month and 6 months
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gingival bleeding
Time Frame: 1 month and 6 months
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bleeding on probing
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1 month and 6 months
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caries status
Time Frame: 1 month and 6 months
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DMFT
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1 month and 6 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Developmental Defects of Enamel
- Stomatognathic Diseases
- Tooth Diseases
- Stomatognathic System Abnormalities
- Congenital Abnormalities
- Tooth Abnormalities
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Amelogenesis Imperfecta
- Equipment and Supplies
- Prostheses and Implants
- Dentistry
- Dental Prosthesis
- Prosthodontics
- Dental Veneers
Other Study ID Numbers
- 2025/129
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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