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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07468019
Enrollment
11
Registered
2026-03-12
Start date
2026-02-01
Completion date
2026-12-01
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ectodermal Dysplasia

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.

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.

Interventions

DEVICE3-D printed overdenture

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

DEVICEConventional overdenture

overdentures will be constructed using Conventional acrylic processing method

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
10 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfactionafter 1 week and after 3 months after delivery of each denturePatient 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.

Secondary

MeasureTime frameDescription
Denture adaptationon delivery day and after 3 months of each denture deliveryDenture adaptation will be measured using surface matching software in deviation values. Unit is µm.

Countries

Egypt

Contacts

CONTACTYasmine Hisham Mohsen
yasmine.hisham@dentistry.cu.edu.eg+201007771412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026