3D-Printed Implant Overdentures: Comparing Impression Techniques
NCT ID: NCT07208812
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
16 participants
INTERVENTIONAL
2026-01-06
2027-05-31
Brief Summary
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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
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Detailed Description
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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:
1. Conventional open-tray implant-level impression
2. Functionally generated reline impression
3. 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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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conventional open -tray impression
Mandibular implant overdenture fabricated using the conventional open tray impression technique at the implant level.
Conventional open -tray impression
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 impression
Mandibular implant overdenture fabricated using functionally generated reline impression technique.
Functionally generated reline impression
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 impression
Mandibular implant overdenture fabricated using mucostatic base and functional borders impression technique.
Mucostatic base with functional borders impression
Intraoral scan of edentulous arch, 3D-printed baseplates for occlusion rim, functional border molding, and digital workflow to fabricate 3D-printed implant overdenture
Interventions
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Conventional open -tray impression
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 impression
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 impression
Intraoral scan of edentulous arch, 3D-printed baseplates for occlusion rim, functional border molding, and digital workflow to fabricate 3D-printed implant overdenture
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
45 Years
ALL
Yes
Sponsors
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Mansoura University
OTHER
Responsible Party
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Shimaa Ebrahim Abo Elenin Ebrahim
Clinical demonstrator at prosthodontics department
Principal Investigators
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Shimaa E Aboelenin
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry, Mansoura University
Locations
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Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MS.25.05.25
Identifier Type: -
Identifier Source: org_study_id
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