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NCT Number: NCT07121881

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

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.

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Key information

Conditions

Edentulous Mandible Behavior Health Behavior Implant-Supported Overdentures Patient Satisfaction Treatment Adherence and Compliance

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Cairo Governorate, 11553, Egypt

Location contact

Hala MF Selim, PhD Candidate

CONTACT

[email protected]

01140733119

About this study

This randomized controlled clinical trial aims to compare the clinical and radiographic outcomes of mandibular implant-supported overdentures using two different attachment systems: bar attachment alone (control group) versus bar with OT Equator attachments (intervention group).

A total of 22 completely edentulous participants will be randomly assigned to either group. Each participant will receive three dental implants placed in the anterior mandible. After healing, bar attachments will be fabricated and delivered. In the intervention group, OT Equator attachments will be added to the bar to enhance retention and flexibility. All participants will receive complete upper and lower dentures.

The study's primary outcome is denture retention, measured using a digital force gauge. Secondary outcomes include crestal bone loss (assessed radiographically), cap wear (measured via electron microscopy), and patient satisfaction (evaluated with a Visual Analog Scale questionnaire).

This study will help inform clinical decisions regarding attachment systems for mandibular overdentures and may provide evidence for improved long-term function and patient-reported outcomes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Completely edentulous healthy patients.
  • Age between 35 and 65 years.
  • Sufficient bone in the anterior and premolar-molar regions (≥11 mm).
  • Adequate inter-arch space (12-14 mm).

Exclusion criteria

  • Severe maxillomandibular skeletal discrepancy.
  • Presence of parafunctional habits such as clenching or bruxism.
  • Temporomandibular joint disorders.
  • Smokers.
  • History of drug abuse.
  • History of head and neck radiation.
  • Systemic disorders that could prevent surgery or affect bone quality (e.g., uncontrolled diabetes, osteoporosis).

Treatment and study plan

Bar Attachment

Device

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.

Bar with OT Equator Attachment

Device

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.

Primary outcomes

  1. Retention of Mandibular Overdenture

    Time frame: At baseline (T0) and 6 months post-insertion (T6)

    Retention will be measured using a digital force gauge. A standardized technique will be used to measure the force required to dislodge the mandibular overdenture by pulling upward from a geometric center marked on the denture.

Secondary outcomes

  1. Crestal Bone Loss Around Implants

    Time frame: At baseline (T0) and 6 months post-insertion (T6)

    Bone level changes will be assessed radiographically using the long cone parallel technique. Crestal bone height will be measured on standardized radiographs at two time points and recorded in millimeters.

  2. Cap Wear of Attachment System

    Time frame: At baseline (T0) and 6 months post-insertion (T6)

    Cap wear will be evaluated by measuring physical changes in the nylon caps of the attachments using an electron microscope. Measurements will be taken in millimeters to assess material degradation.

  3. Patient Satisfaction

    Time frame: At 6 months post-insertion (T6)

    Patients will complete a Visual Analog Scale (VAS) questionnaire assessing overall satisfaction, comfort, speech, chewing ability, aesthetics, and ease of cleaning with the overdenture.

Study contacts

Contact information is provided by the study sponsor or research team.

Hala MF Selim, PhD Candidate

CONTACT

[email protected]

+201140733119

Sponsors and collaborators

Lead sponsor

Hala Abdel salam Selim

Other

Registry information

Official study title

Clinical And Radiographic Evaluation of Mandibular Implant Assisted Overdenture Between Bar Attachment and Bar With OT Equator Attachment: Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

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.

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