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Active Not RecruitingNCT07250503

Compare the Difference in Occlusal Force Distribution and Denture Retention Using 2 Different Denture Base Materials in Implant Retained Overdenture

Impact of Wearing Two Different Implant Retained Mandibular Overdentures on Occlusal Force Distribution and Denture Retention (Randomized Clinical Trial)

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Al-Azhar University · Academic / Other
Sex
All
Age
60 Years – 70 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

24 Patients will be randomly and equally divided into two treatment groups: 1. Group 1: Each patient in this group will receive conventional maxillary and 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. 2. Group 2: Patients in this group received the same type of treatment as the patients in group 1, but the mandibular overdentures were made of the flexible acrylic resin "breflex" The present study will be performed to compare the difference in retention, occlusal force distribution, occlusion and disocclusion time, and bite force for implant retained mandibular over denture using PMMA and flexible dentures base materials

Conditions

Interventions

TypeNameDescription
PROCEDUREConventional acrylic resin dentureMandibular 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.
PROCEDUREFlexible resin dentureMandibular 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

Timeline

Start date
2024-09-01
Primary completion
2026-01-01
Completion
2026-02-01
First posted
2025-11-26
Last updated
2025-11-26

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT07250503. Inclusion in this directory is not an endorsement.