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

NCT07250503 | Active Not Recruiting DMC

• 1 other identifier: 28.4.24
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Edentulous Alveolar Ridge In Mandible; Complete Edentulism; Dental Implant; Attachments; Implant Retained Overdenture; Edentulous Mouth

Keywords

Completely edentulous patients; Dental Implants; Edentulous Ridge

Outcome Measures

Primary Outcomes (1)

• 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

  Follow up visits were scheduled at denture insertion, 6, and 12 months

Secondary Outcomes (4)

• Retention of lower denture

  Follow up visits were scheduled at denture insertion, 6, and 12 months

• occlusion time

  Follow up visits were scheduled at denture insertion, 6, and 12 months

• Biting force

  Follow up visits were scheduled at denture insertion, 6, and 12 months

• Disocclusion time

  Follow up visits were scheduled at denture insertion, 6, and 12 months

Study Arms (2)

Mandibular complete dentures processed into heat cured acrylic resin

ACTIVE COMPARATOR

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 thermoplastic nylon denture

EXPERIMENTAL

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

Interventions

Conventional acrylic resin denture PROCEDURE

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 complete dentures processed into heat cured acrylic resin

Flexible resin denture PROCEDURE

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

Mandibular thermoplastic nylon denture

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients age must range from 60-70 years old.
• All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
• Patients should be free from any metabolic or bone disorder that contraindicate implant installation.
• All patients must have sufficient inter arch space

You may not qualify if:

• Patients with oral or systemic diseases.
• Patients with xerostomia or excessive salivation.
• Patients with parafunctional habits (bruxism or clenching).
• Heavy smoker or alcoholic patients.
• Patients with history of temporo-mandibular dysfunction.
• Patients with brain disorders or psychiatric disorders

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Cairo University

Cairo, 4470351, Egypt

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: September 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Start Date: After publication End Date: 3 years
• Access Criteria: After publication through the corresponding author

Locations

EG (1)