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Mandibular Implant Overdenture With Bar vs OT Equator: A Randomized Controlled Trial

NCT07121881 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-08-14

No results posted yet for this study

Summary

This clinical study will evaluate two types of attachment systems used to support lower dentures in patients who have lost all their lower teeth. All participants will receive dental implants in the lower jaw, and a complete denture that attaches to these implants for better stability and comfort.

The study compares two options:

A traditional bar attachment

A bar with additional OT Equator attachments, which are designed to improve denture retention and reduce wear

Each participant will receive three implants in the lower jaw, and either a bar attachment alone or a bar with OT Equator attachments will be placed. The goal is to find out which method provides better retention of the denture, causes less bone loss around the implants, has less wear on the attachment parts, and leads to higher patient satisfaction.

Participants will be followed over several months. Their denture retention will be tested using a digital force meter, bone levels will be measured through radiographs, cap wear will be examined using an electron microscope, and satisfaction will be recorded using a questionnaire.

This study is being conducted at Cairo University and is self-funded by the primary investigator. Participation is voluntary and does not involve any financial cost to participants.

Conditions

  • Edentulous Mandible
  • Implant-Supported Overdentures

Interventions

DEVICE

Bar Attachment

A bar attachment supported by three mandibular implants (placed in the midline and canine regions) is used to retain a mandibular overdenture. The bar provides rigid splinting across the implants and allows retention using friction or clips, without additional attachment components. This serves as the control group.

DEVICE

Bar with OT Equator Attachment

A bar attachment supported by three mandibular implants is combined with two OT Equator attachments to enhance denture retention and allow slight vertical and rotational resilience. The OT Equator system includes metal housings and retentive nylon caps, intended to reduce cap wear and improve patient comfort. This is the experimental arm.

Sponsors & Collaborators

  • Hala Abdel salam Selim

    lead OTHER

Principal Investigators

  • Hamdy Abo EL-Fotouh, Professor · Faculty of Oral and Dental Medicine, Cairo University

  • Noha Ali, asso. Professor · Faculty of Oral and Dental Medicine, Cairo University

  • Ahmed Hamed, Lecturer · Faculty of Oral and Dental Medicine, Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121881 on ClinicalTrials.gov