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NCT Number: NCT07468019

Organization's Unique Protocol ID

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.

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Key information

Conditions

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

Age range

10 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location status: Recruiting

Location contact

Nouran M Abd ElNabi, Professor

CONTACT

[email protected]

+201001539310

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3-D printed overdenture

Device

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

Conventional overdenture

Device

overdentures will be constructed using Conventional acrylic processing method

Primary outcomes

  1. Patient satisfaction

    Time frame: after 1 week and after 3 months after delivery of each denture

    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.

Secondary outcomes

  1. Denture adaptation

    Time frame: on delivery day and after 3 months of each denture delivery

    Denture adaptation will be measured using surface matching software in deviation values. Unit is µm.

Study contacts

Contact information is provided by the study sponsor or research team.

Yasmine Hisham Mohsen

CONTACT

[email protected]

+201007771412

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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