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

April 1, 2026 updated by: Noha Taha Kamel Taha Alloush, Al-Azhar University

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

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."

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 4470351
        • Oral and Dental Research Institute, National Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. All patients' ages must range from 60-70 years old.
  2. 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.
  3. Patients should be free from any metabolic or bone disorder that contraindicate implant installation.
  4. All patients must have sufficient inter arch space

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OT-Equator Attachment
On the 2nd Stage, implants will be loaded with OT-Equator Attachment to retain overdenture
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
Experimental: Novaloc Attachment
On the 2nd Stage, implants will be loaded with Novaloc Attachment to retain overdenture
Procedure: Novaloc Attachment
Two implants will be restored using Novaloc attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention
Time Frame: It will be measured at denture insertion, 6 months and 12 months
it will be measured using digital force gauge
It will be measured at denture insertion, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Oral Health Impact Profile (OHIP) questionnaire
Time Frame: It will be measured at denture insertion, 6 months and 12 months
It is one of the most technically sophisticated instruments used for assessment of OHRQoL. The OHIP was developed and validated by Slade and Spencer and several versions of the tool have been developed thereafter. Among the available short versions, the OHIP-EDENT has been deemed the most appropriate tool for the edentulous patients, as it presented a set of specific questions. The tool detects the impact of oral health on the quality of life of patients with implant supported overdenture prosthesis, before and after they have received them.
It will be measured at denture insertion, 6 months and 12 months
Patient Satisfaction
Time Frame: it will be measured at denture insertion, 6 month, and 12 month later.
Patient satisfaction was evaluated with a standard 5-point Likert scale questionnaire, which included subjective parameters such as initial adaptability, post insertion problems, aesthetics, masticatory ability, speech, retention. Patients were asked to respond to question given in the questionnaire
it will be measured at denture insertion, 6 month, and 12 month later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: Noha T Alloush, Lecturer, Misr International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 1, 2025

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 6, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 03411225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol and Clinical Study Report

IPD Sharing Time Frame

Start Date: After Publication End Date: 3 Years

IPD Sharing Access Criteria

After publication through corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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