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

NCT07121881 | Not Yet Recruiting

• 1 other identifier: HS-OTBarRCT2024
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

OT Equator attachment; Denture retention; Crestal bone loss; Patient satisfaction; Bar attachment; cap wear

Outcome Measures

Primary Outcomes (1)

• Retention of Mandibular Overdenture

  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.

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

Secondary Outcomes (3)

• Crestal Bone Loss Around Implants

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

• Cap Wear of Attachment System

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

• Patient Satisfaction

  At 6 months post-insertion (T6)

Study Arms (2)

Bar Attachment Only

ACTIVE COMPARATOR

Participants in this group will receive a mandibular implant-assisted overdenture supported by a milled bar attachment only. Three implants will be placed in the anterior mandible (midline and canine regions), and a bar attachment will be fabricated without any additional retentive elements.

Device: Bar Attachment

Bar with OT Equator Attachment

EXPERIMENTAL

Participants in this group will receive a mandibular implant-assisted overdenture supported by a milled bar with OT Equator attachments. Three implants will be placed in the anterior mandible (midline and canine regions). Two OT Equator attachments will be incorporated into the bar to enhance retention and stress distribution.

Device: Bar with OT Equator Attachment

Interventions

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 Attachment Only

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.

Bar with OT Equator Attachment

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hala Abdel salam Selim: lead

Study Sites (1)

Faculty of Oral and Dental Medicine, Cairo University

Cairo, Cairo Governorate, 11553, Egypt

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Hamdy Abo EL-Fotouh, Professor

  Faculty of Oral and Dental Medicine, Cairo University

  STUDY CHAIR

• Noha Ali, asso. Professor

  Faculty of Oral and Dental Medicine, Cairo University

  STUDY DIRECTOR

• Ahmed Hamed, Lecturer

  Faculty of Oral and Dental Medicine, Cairo University

  STUDY DIRECTOR

Central Study Contacts

Hala MF Selim, PhD Candidate

CONTACT

+201140733119; hala.selim@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the outcome assessor (statistician) is blinded to the group allocation. Due to the nature of the interventions, participants and investigators cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate

Model Details: Two-arm randomized controlled trial: Group 1 receives bar attachment only; Group 2 receives bar with OT Equator attachment.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: September 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)