Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Location status: Recruiting
NCT Number: NCT07208812
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
Interested in participating?
Request Info45 year and older
All sexes
Interventional
Not applicable
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Interim prosthesis relieved and reline impression taken during centric closure with border molding, scanned to construct a 3D-printed implant overdenture
Intraoral scan of edentulous arch, 3D-printed baseplates for occlusion rim, functional border molding, and digital workflow to fabricate 3D-printed implant overdenture
Time frame: 3, 6, and 9 months after overdenture insertion
Assessment of chewing efficiency using a color- mixing ability test
Time frame: 3, 6, and 9 months after overdenture insertion
Patient- reported satisfaction measured using the Visual Analog Scale
Contact information is provided by the study sponsor or research team.
Mansoura University
Other
Impact of Impression Techniques on Patient Satisfaction and Chewing Efficiency in 3D-Printed Implant Overdentures: A Crossover Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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