Edentulous MandibleNCT07067190
Mandibular Implant Overdenture With OT Cap Bar vs Bar Attachment
A study testing Conventional Bar Attachment and Bar with OT Cap Attachment in people with Edentulous Mandible and Implant-Supported Overdentures, run by Maisa Mohamed Farid Shaaban at 1 site in Egypt.
Trial summary
This clinical study is being conducted at Cairo University to evaluate two different types of attachments used with implant-supported dentures in the mandible. Patients who have lost all their teeth in the lower jaw receive implants to help hold their dentures in place. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Mandible, Implant-Supported Overdentures
- What is being tested?
- Conventional Bar Attachment and Bar with OT Cap 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 2026to Mar 2027
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completely edentulous healthy patients
- Age between 30 and 65 years
- Adequate bone volume in the anterior and premolar-molar region (minimum 11 mm)
- Adequate inter-arch space (12-14 mm)
Who cannot join
- Severe maxillomandibular skeletal discrepancy
- Parafunctional habits (e.g., clenching, bruxism)
- Temporomandibular joint disorders
- Heavy smokers (≥20 cigarettes/day)
- History of head and neck radiation
- History of chemotherapy
- Systemic conditions that may interfere with healing or bone quality (e.g., uncontrolled diabetes, osteoporosis, bisphosphonate therapy)
- Drug abuse or alcohol dependence
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maisa Farid contact
Egypt1 site
Faculty of Oral and Dental Medicine, Cairo University
Cairo, Cairo Governorate, 11553
Maisa MF Shaaban Gomaa, PhD candidate, 01002730928, maisa.gomaa@dentistry.cu.edu.eg
maisafarid2013@gmail.com
About this study
Official title: Clinical and Radiographic Evaluation of Mandibular Implant Assisted Overdenture Between Bar Attachment and Bar With OT Cap Attachment: Randomized Control Clinical Trial
This clinical study is being conducted at Cairo University to evaluate two different types of attachments used with implant-supported dentures in the mandible. Patients who have lost all their teeth in the lower jaw receive implants to help hold their dentures in place. This study compares two types of attachments for connecting the denture to the implants:
- Bar attachment only, which is a traditional method.
- Bar with OT Cap attachment, which is a newer design that includes a small sphere (cap) to help with retention and comfort.
Read more
The purpose of this study is to find out which attachment type works better in terms of:
- How well the denture stays in place (retention)
- How much bone is lost around the implants over time (crestal bone loss)
- How much the attachment parts wear out (cap wear)
- How satisfied the patients are with their dentures
The study is a randomized controlled trial. This means participants will be randomly assigned to one of the two groups (bar-only or bar with OT Cap). All participants will receive complete dentures and three dental implants in the lower jaw.
Follow-up will include measurements of denture retention and cap wear at the time the denture is inserted and again after 6 months. Bone loss will be checked with digital X-rays, and patient satisfaction will be assessed using a short questionnaire.
The study will include 22 participants (11 in each group), aged 30 to 65, who are healthy and have enough bone in the jaw to support implants.
This study is designed to help dentists and patients make better decisions about which type of implant attachment provides better long-term results and patient comfort.
Read the detailed description
This randomized controlled clinical trial is designed to evaluate and compare the clinical and radiographic outcomes of two mandibular implant-supported overdenture attachment systems: (1) conventional bar attachment, and (2) bar with OT Cap (sphere) attachment. The objective is to determine which system provides superior performance in terms of prosthesis retention, crestal bone preservation, attachment wear, and patient satisfaction.
A total of 22 completely edentulous participants, aged between 30 and 65 years and meeting strict inclusion criteria, will be enrolled. Each participant will receive three endosseous implants placed in the anterior mandibular region (midline and canine positions). Following a four-month osseointegration period, participants will be randomly allocated (1:1) to one of two intervention groups: Group A (bar attachment only) and Group B (bar with OT Cap sphere attachments).
The prosthetic protocol involves the fabrication and delivery of maxillary and mandibular complete dentures, followed by intraoral placement and pick-up of the attachment systems. The primary outcome is denture retention, assessed at baseline (T0) and after 6 months (T6) using a digital force gauge. Secondary outcomes include crestal bone loss (evaluated via standardized digital radiographs), cap wear (measured using electron microscopy), and patient satisfaction (assessed using a validated Visual Analog Scale questionnaire).
Randomization will be conducted using a computer-generated sequence with allocation concealment ensured via opaque sealed envelopes. Due to the nature of the intervention, blinding of participants and clinicians is not feasible; however, outcome assessment and statistical analysis will be performed by a blinded examiner.
This study addresses a critical gap in the comparative assessment of attachment systems for implant-retained mandibular overdentures. While bar attachments are widely used for their rigidity and implant splinting capacity, recent innovations such as the OT Cap aim to enhance retention and reduce maintenance through added resilience. By directly comparing these two configurations in a controlled setting, the study aims to contribute clinically relevant data to guide prosthodontic treatment planning for edentulous patients.
- Being tested
- Conventional Bar Attachment, Bar with OT Cap Attachment
- Keywords
- Bar Attachment, OT Cap Attachment, Implant-Assisted Overdenture, Dental Implants, Mandibular Denture Retention, Crestal Bone Loss, Patient Satisfaction, Attachment 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.
Conventional Bar AttachmentDevice
A rigid cast bar attachment fabricated and screwed onto three mandibular implants (placed at the midline and canine areas). The bar connects the implants to provide splinting and retention for a mandibular overdenture without the use of additional retentive components such as OT Caps. The overdenture is adjusted to fit passively over the bar and picked up intraorally.
Bar with OT Cap AttachmentDevice
A cast bar attachment fitted with two OT Cap attachments, which are designed to improve prosthesis retention and load distribution. This bar system is installed on three mandibular implants (midline and canine regions). The mandibular overdenture is relined to incorporate the female retentive caps that snap onto the OT Caps. This system combines the splinting benefits of the bar with the resilient retention of stud attachments.
| Study group | Role | What they receive |
|---|---|---|
| Bar Attachment Group | Active comparator | Participants in this group will receive mandibular implant-supported overdentures retained by a conventional cast bar attachment. Three implants will be placed in the anterior mandible (midline and canine positions), and a single bar will be fabricated and attached to the implants. The overdenture will be adjusted to fit over the bar with no additional retentive components. This group represents the standard treatment modality for implant-retained overdentures. Receives: Device: Conventional Bar Attachment |
| Bar with OT Cap Attachment Group | Experimental | Participants in this group will receive mandibular implant-supported overdentures using a bar combined with two OT Cap (sphere) attachments for added retention. The same implant placement protocol will be followed as in the comparator group. The bar will include OT Cap housings, and the overdenture will be relined to incorporate the corresponding female caps. This intervention is designed to improve denture retention, reduce component wear, and enhance patient satisfaction. Receives: Device: Bar with OT Cap Attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of Mandibular Implant-Supported Overdenture
Retention will be measured using a digital force gauge that applies a vertical dislodging force to the mandibular overdenture. The force required to dislodge the denture from the attachments will be recorded in Newtons. Measurements will be performed at two time points: at the time of prosthesis insertion (T0) and six months post-insertion (T6). The retention values will be used to compare the effectiveness of bar-only versus bar with OT Cap attachment systems.
Measured: Baseline (T0) and 6 months after overdenture insertion (T6)
Secondary outcomes (3)
Crestal Bone Loss Around Implants
Crestal bone levels will be assessed using standardized digital radiographs with the Digora long-cone parallel technique. Measurements will be taken from the implant shoulder to the first bone-to-implant contact point on mesial and distal surfaces. The difference in bone height between baseline (T0) and six months (T6) will be calculated in millimeters to determine bone loss.
Measured: Baseline (T0) and 6 months after overdenture insertion (T6)
Attachment Cap Wear
Cap wear will be evaluated by measuring the internal diameter changes of the OT Cap components using scanning electron microscopy (SEM). Measurements will be taken at baseline (T0) and after 6 months (T6) to assess material degradation and fit deterioration.
Measured: Baseline (T0) and 6 months after overdenture insertion (T6)
Patient Satisfaction with Overdenture
Patient satisfaction will be assessed using a validated Visual Analog Scale (VAS) questionnaire that evaluates comfort, stability, appearance, chewing ability, speech, ease of cleaning, and overall satisfaction. Each parameter is rated from 0 (not satisfied at all) to 100 (completely satisfied). The results will be used to compare the perceived outcomes between the two intervention groups.
Measured: 6 months after overdenture insertion (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (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 clinical trial comparing bar-only attachment vs. bar with OT Cap attachment in mandibular implant-supported overdentures.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisa Mohamed Farid Shaaban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maisa Mohamed Farid Shaaban, Cairo University
- Investigators
- Maisa MF Shaaban Gomaa, PhD candidate, Principal investigator, Faculty of Oral and Dental Medicine, Cairo UniversityHamdy Abo El-Fotouh, Professor, Study chair, Faculty of Oral and Dental Medicine, Cairo UniversityNoha Ali, Assistant 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
- NCT07067190
- Sponsor's protocol ID
- MF-OTBarRCT2024
- Status last verified
- Mar 2026
- First submitted
- 5 Jul 2025
- Last updated
- 18 Mar 2026
- 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 because this study is self-funded and conducted as part of a doctoral thesis project. No data-sharing mechanism or repository has been established, and participants were not consented for external data sharing. Additionally, confidentiality and ethical guidelines limit redistribution of participant-level data
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. 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 Cap Attachment: Randomized Control Clinical Trial
- ClinicalTrials.gov ID
- NCT07067190
- Acronym / sponsor ID
- MF-OTBarRCT2024
- Keywords
- Bar Attachment, OT Cap Attachment, Implant-Assisted Overdenture, Dental Implants, Mandibular Denture Retention, Crestal Bone Loss, Patient Satisfaction, Attachment Wear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Maisa Mohamed Farid ShaabanUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Jul 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 is being conducted at Cairo University to evaluate two different types of attachments used with implant-supported dentures in the mandible. Patients who have lost all their teeth in the lower jaw receive implants to help hold their dentures in place. This study compares two types of attachments for connecting the denture to the implants:
- Bar attachment only, which is a traditional method.
- Bar with OT Cap attachment, which is a newer design that includes a small sphere (cap) to help with retention and comfort.
The purpose of this study is to find out which attachment type works better in terms of:
- How well the denture stays in place (retention)
- How much bone is lost around the implants over time (crestal bone loss)
- How much the attachment parts wear out (cap wear)
- How satisfied the patients are with their dentures
The study is a randomized controlled trial. This means participants will be randomly assigned to one of the two groups (bar-only or bar with OT Cap). All participants will receive complete dentures and three dental implants in the lower jaw.
Follow-up will include measurements of denture retention and cap wear at the time the denture is inserted and again after 6 months. Bone loss will be checked with digital X-rays, and patient satisfaction will be assessed using a short questionnaire.
The study will include 22 participants (11 in each group), aged 30 to 65, who are healthy and have enough bone in the jaw to support implants.
This study is designed to help dentists and patients make better decisions about which type of implant attachment provides better long-term results and patient comfort.
Detailed description
This randomized controlled clinical trial is designed to evaluate and compare the clinical and radiographic outcomes of two mandibular implant-supported overdenture attachment systems: (1) conventional bar attachment, and (2) bar with OT Cap (sphere) attachment. The objective is to determine which system provides superior performance in terms of prosthesis retention, crestal bone preservation, attachment wear, and patient satisfaction.
A total of 22 completely edentulous participants, aged between 30 and 65 years and meeting strict inclusion criteria, will be enrolled. Each participant will receive three endosseous implants placed in the anterior mandibular region (midline and canine positions). Following a four-month osseointegration period, participants will be randomly allocated (1:1) to one of two intervention groups: Group A (bar attachment only) and Group B (bar with OT Cap sphere attachments).
The prosthetic protocol involves the fabrication and delivery of maxillary and mandibular complete dentures, followed by intraoral placement and pick-up of the attachment systems. The primary outcome is denture retention, assessed at baseline (T0) and after 6 months (T6) using a digital force gauge. Secondary outcomes include crestal bone loss (evaluated via standardized digital radiographs), cap wear (measured using electron microscopy), and patient satisfaction (assessed using a validated Visual Analog Scale questionnaire).
Randomization will be conducted using a computer-generated sequence with allocation concealment ensured via opaque sealed envelopes. Due to the nature of the intervention, blinding of participants and clinicians is not feasible; however, outcome assessment and statistical analysis will be performed by a blinded examiner.
This study addresses a critical gap in the comparative assessment of attachment systems for implant-retained mandibular overdentures. While bar attachments are widely used for their rigidity and implant splinting capacity, recent innovations such as the OT Cap aim to enhance retention and reduce maintenance through added resilience. By directly comparing these two configurations in a controlled setting, the study aims to contribute clinically relevant data to guide prosthodontic treatment planning for edentulous patients.
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 clinical trial comparing bar-only attachment vs. bar with OT Cap attachment in mandibular implant-supported overdentures.
| Arm | Type | Receives |
|---|---|---|
| Bar Attachment Group | Active comparator | Device: Conventional Bar AttachmentParticipants in this group will receive mandibular implant-supported overdentures retained by a conventional cast bar attachment. Three implants will be placed in the anterior mandible (midline and canine positions), and a single bar will be fabricated and attached to the implants. The overdenture will be adjusted to fit over the bar with no additional retentive components. This group represents the standard treatment modality for implant-retained overdentures. |
| Bar with OT Cap Attachment Group | Experimental | Device: Bar with OT Cap AttachmentParticipants in this group will receive mandibular implant-supported overdentures using a bar combined with two OT Cap (sphere) attachments for added retention. The same implant placement protocol will be followed as in the comparator group. The bar will include OT Cap housings, and the overdenture will be relined to incorporate the corresponding female caps. This intervention is designed to improve denture retention, reduce component wear, and enhance patient satisfaction. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Completely edentulous healthy patients
- Age between 30 and 65 years
- Adequate bone volume in the anterior and premolar-molar region (minimum 11 mm)
- Adequate inter-arch space (12-14 mm)
Key exclusion criteria (8 listed)
- Severe maxillomandibular skeletal discrepancy
- Parafunctional habits (e.g., clenching, bruxism)
- Temporomandibular joint disorders
- Heavy smokers (≥20 cigarettes/day)
- History of head and neck radiation
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 |
|---|---|---|
| Conventional Bar AttachmentA rigid cast bar attachment fabricated and screwed onto three mandibular implants (placed at the midline and canine areas). The bar connects the implants to provide splinting and retention for a mandibular overdenture without the use of additional retentive components such as OT Caps. The overdenture is adjusted to fit passively over the bar and picked up intraorally. | Device | Bar Attachment Group |
| Bar with OT Cap AttachmentA cast bar attachment fitted with two OT Cap attachments, which are designed to improve prosthesis retention and load distribution. This bar system is installed on three mandibular implants (midline and canine regions). The mandibular overdenture is relined to incorporate the female retentive caps that snap onto the OT Caps. This system combines the splinting benefits of the bar with the resilient retention of stud attachments. | Device | Bar with OT Cap Attachment Group |
Primary outcome
Retention of Mandibular Implant-Supported Overdenture
Time frame: Baseline (T0) and 6 months after overdenture insertion (T6)
Retention will be measured using a digital force gauge that applies a vertical dislodging force to the mandibular overdenture. The force required to dislodge the denture from the attachments will be recorded in Newtons. Measurements will be performed at two time points: at the time of prosthesis insertion (T0) and six months post-insertion (T6). The retention values will be used to compare the effectiveness of bar-only versus bar with OT Cap attachment systems.
3 secondary outcomes
Crestal Bone Loss Around Implants
Time frame: Baseline (T0) and 6 months after overdenture insertion (T6)
Attachment Cap Wear
Time frame: Baseline (T0) and 6 months after overdenture insertion (T6)
Patient Satisfaction with Overdenture
Time frame: 6 months after overdenture 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 18 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this study is self-funded and conducted as part of a doctoral thesis project. No data-sharing mechanism or repository has been established, and participants were not consented for external data sharing. Additionally, confidentiality and ethical guidelines limit redistribution of participant-level data
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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.
Maisa Farid contact
Maisa MF Shaaban Gomaa, PhD candidate principal investigator
Faculty of Oral and Dental Medicine, Cairo University
Hamdy Abo El-Fotouh, Professor study chair
Faculty of Oral and Dental Medicine, Cairo University
Noha Ali, Assistant Professor 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 Conventional Bar Attachment and Bar with OT Cap Attachment in people with Edentulous Mandible and Implant-Supported Overdentures, run by Maisa Mohamed Farid Shaaban 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 8 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 18 Mar 2026. 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 Maisa MF Shaaban Gomaa, PhD Candidate (+201002730928, maisa.gomaa@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 Implant-Supported Overdenture (time frame: Baseline (T0) and 6 months after overdenture 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 18 Mar 2026.