Edentulous Mandible, Implant-Supported Overdentures
Conditions
Keywords
OT Equator attachment, Denture retention, Crestal bone loss, Patient satisfaction, Bar attachment, cap wear
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.
Interventions
DEVICEBar 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.
DEVICEBar 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
Hala Abdel salam Selim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Only the outcome assessor (statistician) is blinded to the group allocation. Due to the nature of the interventions, participants and investigators cannot be blinded.
Intervention model description
Two-arm randomized controlled trial: Group 1 receives bar attachment only; Group 2 receives bar with OT Equator attachment.
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Egypt
Contacts
Primary ContactHala MF Selim, PhD Candidate
Outcome results
None listed