Skip to main content
OpenTrials
Completed

NCT Number: NCT07513155

"Retention and Quality of Life in Mandibular Overdentures Using Two Attachment Systems: A 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."

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Edentulous Alveolar Ridge in Mandible Attachment Complete Edentulism Dental Implant Implant Retained Overdenture

Age range

60 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oral and Dental Research Institute, National Research Center

Cairo, Cairo Governorate, 4470351, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients' ages 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

Exclusion criteria

  • 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

Treatment and study plan

OT-Equator Attachment

Procedure

Two implants will be restored using OT attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing

Novaloc Attachment

Procedure

Two implants will be restored using Novaloc attachment systems, with the mandibular denture retained over these attachments through corresponding metal housing

Primary outcomes

  1. Retention

    Time frame: It will be measured at denture insertion, 6 months and 12 months

    it will be measured using digital force gauge

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.