Ectodermal DysplasiaNCT07468019
Organization's Unique Protocol ID
A study testing 3-D printed overdenture and Conventional overdenture in people with Ectodermal Dysplasia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 35 years
- Conditions the study is for
- Ectodermal Dysplasia
- What is being tested?
- 3-D printed overdenture and Conventional overdenture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age must range from 10-35 years.
- Must have a few remaining teeth in the maxilla.
- Must will to attend all follow-ups.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Cairo University
Cairo
Nouran M Abd ElNabi, Professor, +201001539310, Nouranabdelnabi@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ectodermal Dysplasia
- Being tested
- 3-D printed overdenture, Conventional overdenture
- Medical subject headings
- Ectodermal Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-D printed overdentureDevice
Overdenture is constructed using 3 -D printing technology not conventional processing of acrylic resin
Conventional overdentureDevice
overdentures will be constructed using Conventional acrylic processing method
| Study group | Role | What they receive |
|---|---|---|
| Digital 3-D printed overdentures | Experimental | Not described Receives: Device: 3-D printed overdenture |
| conventional acrylic overdenture | Active comparator | Not described Receives: Device: Conventional overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: on delivery day and after 3 months of each denture delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectodermal DysplasiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmine Hisham Abd El rahman Mohsen, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468019
- Sponsor's protocol ID
- ED-OD-3DPvsCA-CO-CT-2026
- Status last verified
- Jul 2025
- First submitted
- 19 Jan 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Patient Satisfaction of 3-D Printed Versus Conventional Acrylic Overdentures in Patients With Ectodermal Dysplasia: A Crossover Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT07468019
- Acronym / sponsor ID
- ED-OD-3DPvsCA-CO-CT-2026
- Conditions
- Ectodermal Dysplasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 11 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital 3-D printed overdentures | Experimental | Device: 3-D printed overdenture |
| conventional acrylic overdenture | Active comparator | Device: Conventional overdenture |
Who may qualify
- Ages
- 10 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age must range from 10-35 years.
- Must have a few remaining teeth in the maxilla.
- Must will to attend all follow-ups.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-D printed overdentureOverdenture is constructed using 3 -D printing technology not conventional processing of acrylic resin | Device | Digital 3-D printed overdentures |
| Conventional overdentureoverdentures will be constructed using Conventional acrylic processing method | Device | conventional acrylic overdenture |
Primary outcome
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.
1 secondary outcome
Denture adaptation
Time frame: on delivery day and after 3 months of each denture delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-D printed overdenture and Conventional overdenture in people with Ectodermal Dysplasia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmine Hisham Mohsen (+201007771412, yasmine.hisham@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: after 1 week and after 3 months after delivery of each denture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.