Edentulous MandibleNCT07121881
Mandibular Implant Overdenture With Bar vs OT Equator: A Randomized Controlled Trial
A study testing Bar Attachment and Bar with OT Equator Attachment in people with Edentulous Mandible and Implant-Supported Overdentures, run by Hala Abdel salam Selim at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Mandible, Implant-Supported Overdentures
- What is being tested?
- Bar Attachment and Bar with OT Equator Attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Oral and Dental Medicine, Cairo University
Cairo, Cairo Governorate, 11553
Hala MF Selim, PhD Candidate, 01140733119, hala.selim@dentistry.cu.edu.eg
About this study
Official title: Clinical And Radiographic Evaluation of Mandibular Implant Assisted Overdenture Between Bar Attachment and Bar With OT Equator Attachment: 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:
Read more
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.
Read the 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.
- Being tested
- Bar Attachment, Bar with OT Equator Attachment
- Keywords
- OT Equator attachment, Denture retention, Crestal bone loss, Patient satisfaction, Bar attachment, cap wear
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bar AttachmentDevice
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 AttachmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Bar with OT Equator Attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (T0) and 6 months post-insertion (T6)
Secondary outcomes (3)
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.
Measured: At baseline (T0) and 6 months post-insertion (T6)
Cap Wear of Attachment System
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.
Measured: 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.
Measured: At 6 months post-insertion (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MandibleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized controlled trial: Group 1 receives bar attachment only; Group 2 receives bar with OT Equator attachment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hala Abdel salam Selim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hala Abdel salam Selim, Cairo University
- Investigators
- Hamdy Abo EL-Fotouh, Professor, Study chair, Faculty of Oral and Dental Medicine, Cairo UniversityNoha Ali, asso. Professor, Study director, Faculty of Oral and Dental Medicine, Cairo UniversityAhmed Hamed, Lecturer, Study director, Faculty of Oral and Dental Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121881
- Sponsor's protocol ID
- HS-OTBarRCT2024
- Status last verified
- May 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical And Radiographic Evaluation of Mandibular Implant Assisted Overdenture Between Bar Attachment and Bar With OT Equator Attachment: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07121881
- Acronym / sponsor ID
- HS-OTBarRCT2024
- Keywords
- OT Equator attachment, Denture retention, Crestal bone loss, Patient satisfaction, Bar attachment, cap wear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Hala Abdel salam SelimUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized controlled trial: Group 1 receives bar attachment only; Group 2 receives bar with OT Equator attachment.
| Arm | Type | Receives |
|---|---|---|
| Bar Attachment Only | Active comparator | Device: Bar AttachmentParticipants 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 | Device: Bar with OT Equator AttachmentParticipants 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. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- Severe maxillomandibular skeletal discrepancy.
- Presence of parafunctional habits such as clenching or bruxism.
- Temporomandibular joint disorders.
- Smokers.
- History of drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bar AttachmentA 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. | Device | Bar Attachment Only |
| Bar with OT Equator AttachmentA 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. | Device | Bar with OT Equator Attachment |
Primary outcome
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.
3 secondary outcomes
Crestal Bone Loss Around Implants
Time frame: At baseline (T0) and 6 months post-insertion (T6)
Cap Wear of Attachment System
Time frame: At baseline (T0) and 6 months post-insertion (T6)
Patient Satisfaction
Time frame: At 6 months post-insertion (T6)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No. 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.
Related trials for Edentulous Mandible
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Not yet recruiting
Comparison Between Neutral Zone and Admixed Impression Techniques for Atrophic Mandibular Ridges
Atrophic Mandibular Ridge in Edentulous Patients
Not yet recruiting
Clinical and Radiographic Comparison of Two Implant-Abutment Connections
Dental Implant, Edentulous Alveolar Ridge
Not yet recruiting
Trueness of Intra-Oral Scanners Compared to an Extra-Oral Scanner for Scanning of Mandibular Edentulous Impressions
Edentulous Jaw
Active, not recruitingObservational study
Chart Review: Comparing the Position and Tilt of Dental Implants Versus Those of Natural Teeth
Dental Implant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hamdy Abo EL-Fotouh, Professor study chair
Faculty of Oral and Dental Medicine, Cairo University
Noha Ali, asso. Professor study director
Faculty of Oral and Dental Medicine, Cairo University
Ahmed Hamed, Lecturer study director
Faculty of Oral and Dental Medicine, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bar Attachment and Bar with OT Equator Attachment in people with Edentulous Mandible and Implant-Supported Overdentures, run by Hala Abdel salam Selim at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hala MF Selim, PhD Candidate (+201140733119, hala.selim@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of Mandibular Overdenture (time frame: At baseline (T0) and 6 months post-insertion (T6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.