Organization's Unique Protocol ID

Adaptation and Patient Satisfaction of 3-D Printed Versus Conventional Acrylic Overdentures in Patients With Ectodermal Dysplasia: A Crossover Prospective Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Ectodermal Dysplasia
• Intervention / Treatment: Device: 3-D printed overdenture; Device: Conventional overdenture

Detailed Description

Ectodermal dysplasia patients suffer from partial anodontia, the reduced number of teeth leads to decreased ridge development and reduced surface area of denture which negatively affects the denture adaptation. Conventionally constructed dentures are well accepted but have high polymerization shrinkage which affects denture adaptation. 3D printed dentures offer less polymerization shrinkage when compared to conventional dentures. Clinical studies that investigated digitally manufactured, especially 3D printed, dentures in ectodermal dysplasia patients and their impact on patient satisfaction and denture adaptation are very scarce in dental literature.

• Study Type: Interventional
• Enrollment (Estimated): 11
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasmine Hisham Mohsen; Phone Number: +201007771412; Email: yasmine.hisham@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Faculty of Dentistry, Cairo University
    • Contact: Nouran M Abd ElNabi, Professor; Phone Number: +201001539310; Email: Nouranabdelnabi@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

  4. Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital 3-D printed overdentures	Device: 3-D printed overdenture; Overdenture is constructed using 3 -D printing technology not conventional processing of acrylic resin
Active Comparator: conventional acrylic overdenture	Device: Conventional overdenture; overdentures will be constructed using Conventional acrylic processing method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Denture adaptation	Denture adaptation will be measured using surface matching software in deviation values. Unit is µm.	on delivery day and after 3 months of each denture delivery

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Skin Diseases; Congenital Abnormalities; Abnormalities, Multiple; Skin Diseases, Genetic; Skin Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Ectodermal Dysplasia
• Other Study ID Numbers: ED-OD-3DPvsCA-CO-CT-2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No