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

Not Applicable

Not yet recruiting

• Conditions: Edentulous Mandible; Implant-Supported Overdentures

• Registration Number: NCT07121881
• Lead Sponsor: Hala Abdel salam Selim

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Study Start: 2025-09-01
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Retention of Mandibular Overdenture	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 Outcome Measures

Name	Time	Method
Crestal Bone Loss Around Implants	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.
Patient Satisfaction	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.
Cap Wear of Attachment System	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.

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine, Cairo University; 🇪🇬 Cairo, Cairo Governorate, Egypt