Organization's Unique Protocol ID

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-35
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age must range from 10-35 years.

Must have a few remaining teeth in the maxilla.

Must will to attend all follow-ups.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

11 Participants
are divided into 2 treatment groups
Group A: Digital 3-D printed overdenturesExperimental treatment 1 intervention
Group B: conventional acrylic overdentureActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Denture adaptation

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

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

Other outcomes

Sponsors and contacts

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