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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
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional open -tray impression | Experimental | Mandibular implant overdenture fabricated using the conventional open tray impression technique at the implant level. |
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| Functionally generated reline impression | Experimental | Mandibular implant overdenture fabricated using functionally generated reline impression technique. |
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| Mucostatic base with functional borders impression | Experimental | Mandibular implant overdenture fabricated using mucostatic base and functional borders impression technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional open -tray impression | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Masticatory efficiency | Assessment of chewing efficiency using a color- mixing ability test | 3, 6, and 9 months after overdenture insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient- reported satisfaction measured using the Visual Analog Scale | 3, 6, and 9 months after overdenture insertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shimaa E Aboelenin | Contact | 01113786860 | shimaaaboelenin@mans.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Shimaa E Aboelenin | Faculty of Dentistry, Mansoura University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Mansoura University | Recruiting | Al Mansurah | Dakahlia Governorate | 35516 | Egypt |
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Functionally generated reline impression | Procedure | Interim prosthesis relieved and reline impression taken during centric closure with border molding, scanned to construct a 3D-printed implant overdenture |
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| Mucostatic base with functional borders impression | Procedure | Intraoral scan of edentulous arch, 3D-printed baseplates for occlusion rim, functional border molding, and digital workflow to fabricate 3D-printed implant overdenture |
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