NCT07271641

A Study Comparing Two Different Denture Base Materials in Implant Retained Overdentures

Clinical and Microbial Evaluation of Two Different Implant Retained Mandibular Overdentures (Randomized Clinical Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 60 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of removable prosthodontics is not only to restore lost oral structures but also to preserve the remaining tissues. Implant-retained overdentures have shown superior outcomes over conventional dentures by reducing residual ridge resorption, enhancing prosthesis support and retention, and improving patients' quality of life. Retention can be further optimized through the use of various attachment systems such as bars, studs, magnets, and telescopic crowns. Traditional PMMA denture bases have limited flexibility, making their extension into soft-tissue undercuts challenging. The introduction of flexible resin materials has improved adaptation to deeper undercuts, enhancing retention while minimizing patient discomfort and absorbing functional stresses. Additionally, flexible resins may reduce microbial colonization by improving blood circulation to the underlying mucosa and supporting salivary defense mechanisms against Candida albicans. Recently, innovative attachment systems such as Novaloc have been developed, featuring PEEK retentive caps and an amorphous diamond-like carbon coating to minimize wear and maintain long-term retention. Their versatile design allows better accommodation of gingival variations and contributes to improved patient satisfaction and treatment success.

Detailed description

The present study will be performed to compare the difference in microbial accumulation, quality of life and patient satisfaction for implant retained mandibular overdenture using both conventional PMMA and flexible denture base materials. 16 Patients will be equally divided into two treatment groups: Group 1: Each patient in this group will receive conventional maxillary and mandibular complete dentures made of heat-cured acrylic resin. In the mandible, two implants were inserted and retained by Novaloc attachments. Group 2: Patients in this group will receive the same type of treatment as the patients in group1 but the mandibular overdentures were made of the flexible acrylic resin

Conditions

• Edentulous Alveolar Ridge In Mandible
• Edentulous Jaw
• Edentulous Mouth
• Implant Supported Overdenture
• Attachments
• Dental Implant
• Complete Edentulism

Interventions

Type	Name	Description
PROCEDURE	Conventional acrylic resin denture	Mandibular complete dentures made of heat-cured acrylic resin polymethylmethacrylate (PMMA). In the mandible, two implants were inserted in the symphyseal area and retained by Novaloc attachments.
PROCEDURE	Flexible 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 Novaloc attachments

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-11-01
• Completion: 2025-11-20
• First posted: 2025-12-09
• Last updated: 2025-12-09

Locations

1 site across 1 country: Egypt