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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Crestal Bone Loss Around Implants | 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. | At baseline (T0) and 6 months post-insertion (T6) |
| Cap Wear of Attachment System |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hala MF Selim, PhD Candidate | Contact | +201140733119 | hala.selim@dentistry.cu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Oral and Dental Medicine, Cairo University | Cairo | Cairo Governorate | 11553 | Egypt |
Individual participant data (IPD) will not be shared to protect participant confidentiality and because no formal mechanisms are in place for data sharing beyond the study team. Data will remain securely stored at Cairo University and accessible only to the authorized research team.
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| ID | Term |
|---|---|
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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Two-arm randomized controlled trial: Group 1 receives bar attachment only; Group 2 receives bar with OT Equator attachment.
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Only the outcome assessor (statistician) is blinded to the group allocation. Due to the nature of the interventions, participants and investigators cannot be blinded.
|
| 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. |
|
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. |
| At baseline (T0) and 6 months post-insertion (T6) |
| Patient Satisfaction | Patients will complete a Visual Analog Scale (VAS) questionnaire assessing overall satisfaction, comfort, speech, chewing ability, aesthetics, and ease of cleaning with the overdenture. | At 6 months post-insertion (T6) |
| Ahmed Hamed, Lecturer | Faculty of Oral and Dental Medicine, Cairo University | Study Director |