Organization's Unique Protocol ID

NCT07468019 | Recruiting

• 1 other identifier: ED-OD-3DPvsCA-CO-CT-2026
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Ectodermal dysplasia is a rare inherited condition that affects structures derived from the ectoderm, including teeth, skin, hair, and sweat glands. Dental findings are often severe and include missing or malformed teeth and poorly developed jaw ridges. These abnormalities can significantly affect chewing, speech, facial appearance, and quality of life, especially in children and young adults. Removable dentures, particularly overdentures when some teeth are present, are commonly used to restore function and appearance in these patients because they are conservative and cost-effective. However, conventional acrylic dentures may show dimensional changes during processing, which can lead to poor denture fit, reduced retention, and lower patient satisfaction. Three-dimensional (3-D) printed dentures are a newer digital fabrication method that may reduce material shrinkage and improve denture adaptation. Despite these potential advantages, clinical evidence comparing 3-D printed and conventional overdentures in patients with ectodermal dysplasia remains limited, highlighting the need for well-designed clinical studies. The purpose of this study is to compare patient satisfaction and denture base adaptation between 3-D printed maxillary overdentures and conventional acrylic maxillary overdentures in patients with ectodermal dysplasia.

Conditions

Ectodermal Dysplasia

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  Patient satisfaction will be measured using patient satisfaction questionnaire in ordinal scale. It uses a 5- point Likert scale to give a removable denture satisfaction index.

  after 1 week and after 3 months after delivery of each denture

Secondary Outcomes (1)

• Denture adaptation

  on delivery day and after 3 months of each denture delivery

Study Arms (2)

Digital 3-D printed overdentures

EXPERIMENTAL

Device: 3-D printed overdenture

conventional acrylic overdenture

ACTIVE COMPARATOR

Device: Conventional overdenture

Interventions

3-D printed overdenture DEVICE

Overdenture is constructed using 3 -D printing technology not conventional processing of acrylic resin

Digital 3-D printed overdentures

Conventional overdenture DEVICE

overdentures will be constructed using Conventional acrylic processing method

conventional acrylic overdenture

Eligibility Criteria

• Age: 10 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age must range from 10-35 years.
• Must have a few remaining teeth in the maxilla.
• Must will to attend all follow-ups.

You may not qualify if:

• Extreme anatomical limitations such as a large torus that requires surgical excision.
• Allergy to dentures made of resins.
• Pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
• \. Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Ectodermal Dysplasia

Condition Hierarchy (Ancestors)

Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Yasmine Hisham Mohsen

CONTACT

+201007771412; yasmine.hisham@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: March 12, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2025-07

Locations

EG (1)