NCT07513155

"Retention and Quality of Life in Mandibular Overdentures Using Two Attachment Systems: A Randomized Clinical Trial"

Effect of Using Two Different Attachments Supporting Mandibular Overdenture on Retention and Quality of Life (Randomized Clinical Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 60 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This randomized clinical trial investigates the effect of two different attachment systems-Equator and Novaloc-on the retention, patient satisfaction, and oral health-related quality of life of mandibular implant overdentures. Completely edentulous patients often experience reduced denture stability, compromised chewing ability, and diminished oral function with conventional complete dentures. Implant-retained overdentures have been shown to improve retention, stability, and overall patient satisfaction. Equator attachments offer a small, resilient, and self-aligning system with variable retention levels, while Novaloc attachments feature innovative PEEK caps and a diamond-like carbon coating designed to reduce wear and maintain long-term retention. This study aims to determine whether one attachment system provides superior functional outcomes and patient-centered benefits, thereby guiding clinicians in optimizing overdenture therapy for edentulous patients."

Detailed description

All 26 patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be randomly divided into two equal groups; Group I will be retained by Novaloc attachment. While, Group II will be retained by Equator attachment. Implants will be functionally loaded after three months of insertion. Retention of lower denture will be measured using digital force gauge, Oral health quality of life will be measured by verbal The Oral Health Impact Profile (OHIP) questionnaire. Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire. All parameters will be measured at denture insertion, 6 month, and 12 month later.

Conditions

• Edentulous Alveolar Ridge In Mandible
• Complete Edentulism
• Dental Implant
• Implant Retained Overdenture
• Attachment

Interventions

Type	Name	Description
PROCEDURE	OT-Equator Attachment	Two implants will be restored using OT attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing
PROCEDURE	Novaloc Attachment	Two implants will be restored using Novaloc attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: Egypt