EdentulismM15011122NCT07373340
A Pilot Randomized Clinical Study Comparing Patient-Reported Outcomes and Complications for Mandibular Implant Overdentures Retained by Different Splinted Attachment Systems
A study testing overdentures with bar locator attachments and overdentures with bar ball attachments in people with Edentulism, run by Mansoura University at 1 site in Egypt.
Trial summary
This exploratory pilot randomized clinical study enrolled ten completely edentulous participants who experienced retention and stability problems with conventional mandibular complete dentures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Edentulism
- What is being tested?
- overdentures with bar locator attachments and overdentures with bar ball attachments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligibility criteria incomplete mandibular edentulism for at least one year, adequate bone volume in the interforaminal region to permit implant placement, a documented history of insufficient retention and/or stability with a conventional mandibular complete denture.
Who cannot join
- comprised uncontrolled systemic diseases, previous radiotherapy to the head and neck region, severe parafunctional habits, and any medical or local contraindications to implant surgery.
- -
Trial locations and contacts
1 site in 1 country.
About this study
This exploratory pilot randomized clinical study enrolled ten completely edentulous participants who experienced retention and stability problems with conventional mandibular complete dentures. Participants were randomly allocated to receive mandibular implant-supported overdentures retained by either a bar-locator attachment system (n = 5) or a bar-ball attachment system (n = 5). Denture satisfaction was assessed using the McGill Denture Satisfaction Questionnaire
- Conditions
- Edentulism
- Being tested
- overdentures with bar locator attachments, overdentures with bar ball attachments
- Keywords
- implant, overdenture, bar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
overdentures with bar locator attachmentsOther
Patients were given overdentures with bar locator attachments
overdentures with bar ball attachmentsOther
Patients were given overdentures with bar ball attachments
| Study group | Role | What they receive |
|---|---|---|
| Group I (bar locator): Patients were given overdentures with bar locator attachments, | Other | Not described Receives: Other: overdentures with bar locator attachments |
| Group2: Patients were given overdentures with bar ball attachments | Other | Not described Receives: Other: overdentures with bar ball attachments |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-reported outcomes
Patient satisfaction (primary outcome) between bar locator and bar ball using a McGill-based study at T0 and after 6 months of overdenture insertion
Measured: Patient satisfaction (primary outcome) at T0 and after 6 months of overdenture insertion
complications
prosthetic complication between bar locator and bar ball
Measured: prosthetic complication was evaluated From enrollment to the end of treatment at 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Nov 2022
- Primary completion1 Jan 2026
- Study completion1 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdentulismStudies 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Wageh Abozaed Elsaed Mansour, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373340
- Sponsor's protocol ID
- M15011122
- Other IDs
- M15011122
- Acronym
- M15011122
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Clinical Study Comparing Patient-Reported Outcomes and Complications for Mandibular Implant Overdentures Retained by Different Splinted Attachment Systems
- ClinicalTrials.gov ID
- NCT07373340
- Acronym / sponsor ID
- M15011122 / M15011122
- Conditions
- Edentulism
- Keywords
- implant, overdenture, bar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Jan 2026 (actual)
- First posted
- 28 Jan 2026 (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 exploratory pilot randomized clinical study enrolled ten completely edentulous participants who experienced retention and stability problems with conventional mandibular complete dentures. Participants were randomly allocated to receive mandibular implant-supported overdentures retained by either a bar-locator attachment system (n = 5) or a bar-ball attachment system (n = 5). Denture satisfaction was assessed using the McGill Denture Satisfaction Questionnaire
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (bar locator): Patients were given overdentures with bar locator attachments, | Other | Other: overdentures with bar locator attachments |
| Group2: Patients were given overdentures with bar ball attachments | Other | Other: overdentures with bar ball attachments |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eligibility criteria incomplete mandibular edentulism for at least one year, adequate bone volume in the interforaminal region to permit implant placement, a documented history of insufficient retention and/or stability with a conventional mandibular complete denture.
Key exclusion criteria (2 listed)
- comprised uncontrolled systemic diseases, previous radiotherapy to the head and neck region, severe parafunctional habits, and any medical or local contraindications to implant surgery.
- -
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 |
|---|---|---|
| overdentures with bar locator attachmentsPatients were given overdentures with bar locator attachments | Other | Group I (bar locator): Patients were given overdentures with bar locator attachments, |
| overdentures with bar ball attachmentsPatients were given overdentures with bar ball attachments | Other | Group2: Patients were given overdentures with bar ball attachments |
Primary outcome
patient-reported outcomes
Time frame: Patient satisfaction (primary outcome) at T0 and after 6 months of overdenture insertion
Patient satisfaction (primary outcome) between bar locator and bar ball using a McGill-based study at T0 and after 6 months of overdenture insertion
complications
Time frame: prosthetic complication was evaluated From enrollment to the end of treatment at 3 years
prosthetic complication between bar locator and bar ball
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing overdentures with bar locator attachments and overdentures with bar ball attachments in people with Edentulism, run by Mansoura University 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient-reported outcomes (time frame: Patient satisfaction (primary outcome) at T0 and after 6 months of overdenture insertion). The study lists 2 primary outcomes in all. 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 28 Jan 2026.