An interventional study of Conventional acrylic resin denture and Flexible resin denture in Edentulous Alveolar Ridge In Mandible, Complete Edentulism and Dental Implant, sponsored by Al-Azhar University. Active, not recruiting at 1 site in Egypt. Open to participants aged 60 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
The global increase in the aging population has led to a rise in total edentulism, which remains a major public health concern. two-implant-retained mandibular overdentures have been regarded as the standard of care, offering superior retention, stability, comfort, and masticatory efficiency compared to conventional dentures. Among available attachment systems-bar, ball, stud, and magnet-the Equator attachment has gained popularity due to its low vertical profile, suitability for limited inter-occlusal space, and ease of handling.
Assessment of masticatory performance and occlusal balance can be objectively measured using devices such as bite force analyzers and the computerized T-Scan system, which quantifies occlusion and disocclusion times.
Conventional heat-cured polymethyl methacrylate (PMMA) remains the most widely used denture base material; however, it has mechanical and biological limitations. Flexible denture base materials have been introduced to overcome these drawbacks by enhancing adaptation, distributing occlusal loads more evenly, and improving comfort and retention.
24 Patients will be randomly and equally divided into two treatment groups:
244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.
This study's enrollment of 24 is below the median of 30 across 187 interventional studies indexed under Mouth, Edentulous.
Browse Mouth, Edentulous studies →Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Mandibular complete dentures made of heat-cured acrylic resin (PMMA). In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments.
Procedure: Conventional acrylic resin denture
Mandibular overdentures were made of the flexible acrylic resin breflex, In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments.
Procedure: Flexible resin denture
Mandibular complete dentures made of heat-cured acrylic resin (PMMA). In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments.
Mandibular overdentures were made of the flexible acrylic resin breflex, In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments
Occlusal force distribution
Occlusal force distribution will be measured by T-Scan, The latest version (T-Scan III) provides a dynamic visual evaluation of a patient's occlusion from initial tooth contact to maximum intercuspation. The system records relative force values and allows objective quantitative evaluation of occlusal balance by recording numerical values for occlusion and disocclusion times
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
Retention of lower denture
Retention of lower denture will be measured using digital force gauge, Retention will be measured using digital force gauge A digital force meter was used to measure denture resistance to vertical displacement (i.e., retention) by applying a pulling force on a metal hook located in the geometric center of each mandibular conventional denture that was identified on the lower cast at the intersection of three lines bisecting the angles of the triangle, formed by both retromolar pads and the midline. Measurement of mandibular denture retention: The patient was instructed to place his head on chin rest and occlusal plane was set parallel to the floor. Tongue freedom was checked then and three minutes seating time was allowed before taking the measurements. A vertical pulling force was applied using the metallic probe of the digital force-meter that was attached to the hook present at the geometric center of mandibular denture. Average value of six readings was recorded.
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
occlusion time
occlusion and disocclusion time will be measured by T-Scan, The latest version (T-Scan III) provides a dynamic visual evaluation of a patient's occlusion from initial tooth contact to maximum intercuspation. The system records relative force values and allows objective quantitative evaluation of occlusal balance by recording numerical values for occlusion times
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
Biting force
Biting force will be measured by bite force meter
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
Disocclusion time
will be measured by T-Scan, The latest version (T-Scan III) provides a dynamic visual evaluation of a patient's occlusion from initial tooth contact to maximum intercuspation. The system records relative force values and allows objective quantitative evaluation of occlusal balance by recording numerical values for disocclusion times
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
Plan to share: Yes — Study Protocol and Clinical Study Report
Supporting information: Study protocol, Csr
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Al-Azhar University