EdentulismNCT07208812
3D-Printed Implant Overdentures: Comparing Impression Techniques
A study testing Conventional open -tray impression, Functionally generated reline impression and Mucostatic base with functional borders impression in people with Edentulism, run by Mansoura University at 1 site in Egypt.
Trial summary
This randomized crossover clinical trial aims to compare three different impression techniques for the construction of 3d-printed mandibular implant overdentures in completely edentulous patients. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulism
- What is being tested?
- Conventional open -tray impression, Functionally generated reline impression and Mucostatic base with functional borders impression
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jan 2026to 31 May 2027
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy patients, free from systemic diseases that affect bone resorption (e.g., uncontrolled diabetes, osteoporosis)
- Residual alveolar ridges covered with healthy, firm mucosa
- Adequate mandibular bone length and width to accommodate standard implant sizes.
- Angle's Class I maxillo-mandibular relationship.
Who cannot join
- Absolute contraindications to implant placement (e.g., active cancer, immune system diseases)
- History of head and neck irradiation or chemotherapy within the past 3 years
- Metabolic bone diseases such as uncontrolled diabetes, osteoporosis, or hyperparathyroidism
- Parafunctional habits such as bruxism or clenching
- Smoking or alcoholism
- Any physical or medical condition that may interfere with study follow-up or implant success
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, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
Shimaa E Aboelenin, 01113786860, shimaaaboelenin@mans.edu.eg
About this study
Official title: Impact of Impression Techniques on Patient Satisfaction and Chewing Efficiency in 3D-Printed Implant Overdentures: A Crossover Study
This randomized crossover clinical trial aims to compare three different impression techniques for the construction of 3d-printed mandibular implant overdentures in completely edentulous patients. Sixteen patients will receive two mandibular implants and three overdentures fabricated using:(1) conventional open-tray implant level impression (2) functionally generated reline impression, and (3)mucostatic base with functional borders impression. Each overdenture will be worn for three months with a washout period between interventions.
The primary outcome is masticatory efficiency, assessed using a color -mixing ability test at 3,6, and9 months.
Secondary outcome is patient satisfaction, assessed using a Visual Analog Scale (VAS) at the same intervals. the study hypothesis is that the impression technique influences both chewing efficiency and patient satisfaction
Read the detailed description
Edentulism has a significant impact on oral function and quality of life. The use of mandibular implant overdentures supported by two implants is widely considered the minimum standard of care, providing improved stability, function, and patient satisfaction compared with conventional complete dentures. Recently, digital workflows and additive manufacturing (3D printing) have created new opportunities for fabricating complete dentures with improved efficiency and reduced costs.
Several impression techniques are currently available for implant-retained overdentures, but there is limited evidence on how these techniques influence functional outcomes and patient-reported satisfaction, particularly when using 3D-printed prostheses.
This randomized crossover clinical trial will be conducted at the Faculty of Dentistry, Mansoura University. Sixteen completely edentulous patients aged 45-70 years will receive two implants placed in the mandibular canine region. After the osseointegration period, each participant will be provided with three different mandibular implant overdentures fabricated using different impression techniques:
- Conventional open-tray implant-level impression
- Functionally generated reline impression
- Mucostatic base with functional borders impression Each overdenture will be worn for a period of three months, with a two-week washout period using a provisional denture before switching to the next overdenture. Randomization will determine the sequence of interventions for each patient.
The primary outcome is masticatory efficiency, measured with a color-mixing ability test at 3, 6, and 9 months. The secondary outcome is patient satisfaction, measured using a Visual Analog Scale (VAS) at the same intervals.
The study is designed to provide evidence on whether the choice of impression technique affects clinical and patient-centered outcomes in 3D-printed mandibular implant overdentures.
- Conditions
- Edentulism
- Being tested
- Conventional open -tray impression, Functionally generated reline impression, Mucostatic base with functional borders impression
- Keywords
- 3D-Printed Implant Overdenture, Impression Techniques, Chewing Efficiency, Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional open -tray impressionProcedure or surgery
Primary impression with irreversible hydrocolloid, custom tray with open window, and final impression with silicone material around impression copings to fabricate a 3D-printed implant overdenture
Functionally generated reline impressionProcedure or surgery
Interim prosthesis relieved and reline impression taken during centric closure with border molding, scanned to construct a 3D-printed implant overdenture
Mucostatic base with functional borders impressionProcedure or surgery
Intraoral scan of edentulous arch, 3D-printed baseplates for occlusion rim, functional border molding, and digital workflow to fabricate 3D-printed implant overdenture
| Study group | Role | What they receive |
|---|---|---|
| conventional open -tray impression | Experimental | Mandibular implant overdenture fabricated using the conventional open tray impression technique at the implant level. Receives: Procedure: Conventional open -tray impression |
| Functionally generated reline impression | Experimental | Mandibular implant overdenture fabricated using functionally generated reline impression technique. Receives: Procedure: Functionally generated reline impression |
| Mucostatic base with functional borders impression | Experimental | Mandibular implant overdenture fabricated using mucostatic base and functional borders impression technique. Receives: Procedure: Mucostatic base with functional borders impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masticatory efficiency
Assessment of chewing efficiency using a color- mixing ability test
Measured: 3, 6, and 9 months after overdenture insertion
Secondary outcomes (1)
Patient satisfaction
Patient- reported satisfaction measured using the Visual Analog Scale
Measured: 3, 6, and 9 months after overdenture insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start6 Jan 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Ebrahim Abo Elenin Ebrahim, Mansoura University
- Investigators
- Shimaa E Aboelenin, Principal investigator, Faculty of Dentistry, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208812
- Sponsor's protocol ID
- MS.25.05.25
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Impression Techniques on Patient Satisfaction and Chewing Efficiency in 3D-Printed Implant Overdentures: A Crossover Study
- ClinicalTrials.gov ID
- NCT07208812
- Acronym / sponsor ID
- MS.25.05.25
- Conditions
- Edentulism
- Keywords
- 3D-Printed Implant Overdenture, Impression Techniques, Chewing Efficiency, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 6 Oct 2025 (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.
This randomized crossover clinical trial aims to compare three different impression techniques for the construction of 3d-printed mandibular implant overdentures in completely edentulous patients. Sixteen patients will receive two mandibular implants and three overdentures fabricated using:(1) conventional open-tray implant level impression (2) functionally generated reline impression, and (3)mucostatic base with functional borders impression. Each overdenture will be worn for three months with a washout period between interventions.
The primary outcome is masticatory efficiency, assessed using a color -mixing ability test at 3,6, and9 months.
Secondary outcome is patient satisfaction, assessed using a Visual Analog Scale (VAS) at the same intervals. the study hypothesis is that the impression technique influences both chewing efficiency and patient satisfaction
Detailed description
Edentulism has a significant impact on oral function and quality of life. The use of mandibular implant overdentures supported by two implants is widely considered the minimum standard of care, providing improved stability, function, and patient satisfaction compared with conventional complete dentures. Recently, digital workflows and additive manufacturing (3D printing) have created new opportunities for fabricating complete dentures with improved efficiency and reduced costs.
Several impression techniques are currently available for implant-retained overdentures, but there is limited evidence on how these techniques influence functional outcomes and patient-reported satisfaction, particularly when using 3D-printed prostheses.
This randomized crossover clinical trial will be conducted at the Faculty of Dentistry, Mansoura University. Sixteen completely edentulous patients aged 45-70 years will receive two implants placed in the mandibular canine region. After the osseointegration period, each participant will be provided with three different mandibular implant overdentures fabricated using different impression techniques:
- Conventional open-tray implant-level impression
- Functionally generated reline impression
- Mucostatic base with functional borders impression Each overdenture will be worn for a period of three months, with a two-week washout period using a provisional denture before switching to the next overdenture. Randomization will determine the sequence of interventions for each patient.
The primary outcome is masticatory efficiency, measured with a color-mixing ability test at 3, 6, and 9 months. The secondary outcome is patient satisfaction, measured using a Visual Analog Scale (VAS) at the same intervals.
The study is designed to provide evidence on whether the choice of impression technique affects clinical and patient-centered outcomes in 3D-printed mandibular implant overdentures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional open -tray impression | Experimental | Procedure: Conventional open -tray impressionMandibular implant overdenture fabricated using the conventional open tray impression technique at the implant level. |
| Functionally generated reline impression | Experimental | Procedure: Functionally generated reline impressionMandibular implant overdenture fabricated using functionally generated reline impression technique. |
| Mucostatic base with functional borders impression | Experimental | Procedure: Mucostatic base with functional borders impressionMandibular implant overdenture fabricated using mucostatic base and functional borders impression technique. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy patients, free from systemic diseases that affect bone resorption (e.g., uncontrolled diabetes, osteoporosis)
- Residual alveolar ridges covered with healthy, firm mucosa
- Adequate mandibular bone length and width to accommodate standard implant sizes.
- Angle's Class I maxillo-mandibular relationship.
Key exclusion criteria (6 listed)
- Absolute contraindications to implant placement (e.g., active cancer, immune system diseases)
- History of head and neck irradiation or chemotherapy within the past 3 years
- Metabolic bone diseases such as uncontrolled diabetes, osteoporosis, or hyperparathyroidism
- Parafunctional habits such as bruxism or clenching
- Smoking or alcoholism
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 |
|---|---|---|
| Conventional open -tray impressionPrimary impression with irreversible hydrocolloid, custom tray with open window, and final impression with silicone material around impression copings to fabricate a 3D-printed implant overdenture | Procedure or surgery | conventional open -tray impression |
| Functionally generated reline impressionInterim prosthesis relieved and reline impression taken during centric closure with border molding, scanned to construct a 3D-printed implant overdenture | Procedure or surgery | Functionally generated reline impression |
| Mucostatic base with functional borders impressionIntraoral scan of edentulous arch, 3D-printed baseplates for occlusion rim, functional border molding, and digital workflow to fabricate 3D-printed implant overdenture | Procedure or surgery | Mucostatic base with functional borders impression |
Primary outcome
Masticatory efficiency
Time frame: 3, 6, and 9 months after overdenture insertion
Assessment of chewing efficiency using a color- mixing ability test
1 secondary outcome
Patient satisfaction
Time frame: 3, 6, and 9 months after overdenture insertion
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 29 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Shimaa E Aboelenin principal investigator
Faculty of Dentistry, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional open -tray impression, Functionally generated reline impression and Mucostatic base with functional borders impression in people with Edentulism, run by Mansoura 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 4 inclusion and 6 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 29 Jan 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 Shimaa E Aboelenin (01113786860, shimaaaboelenin@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masticatory efficiency (time frame: 3, 6, and 9 months after overdenture insertion). 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 29 Jan 2026.