EdentulismNCT06673186
Patient Satisfaction and Prosthetic Complications of Bar Locator Versus Bar Clip Attachments for Mandibular Two-Implant Overdentures
A study testing overdenture in people with Edentulism, run by Mansoura University at 1 site in Egypt.
Trial summary
Purpose: This study evaluated patient satisfaction and oral health-related- quality of life (OHRQoL) with implant overdentures retained with bar locator versus bar clip attachment for mandibular two-implant overdentures. Materials and methods: This study included sixteen edentulous patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Edentulism
- What is being tested?
- overdenture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Nov 2022to 1 Jan 2024
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Each patient had sufficient remaining alveolar ridge in the upper and lower jaw to support implants in the lower jaw area
- a minimum length of 11 mm and a diameter of 3.7 mm, as confirmed by cone beam computed tomography.
- patient had a class I jaw relationship
- adequate space between the arches.
- healthy, firm gum tissue.
Who cannot join
- participants with uncontrolled diabetes,
- heavy smoking
- drinking habits
- temporomandibular joint (TMJ) issues.
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: This study evaluated patient satisfaction and oral health-related- quality of life (OHRQoL) with implant overdentures retained with bar locator versus bar clip attachment for mandibular two-implant overdentures. Materials and methods: This study included sixteen edentulous patients. Every patient received new maxillary and mandibular dentures. Two dental implants have been embedded in the mandibular canine areas. The participants were randomly divided into two equal groups: Group I (bar locator): Patients were given overdentures with bar locator attachments, Group II (bar clip): Patients were given overdentures with bar clip attachment. Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.
The aim of this study was to document and report on the prosthetic complications associated with mandibular implant overdentures using bar locator and bar clip attachments. The study aimed to test the null hypothesis that the complications would not differ based on the type of retention (locator or clip).
- Conditions
- Edentulism
- Being tested
- overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
overdentureOther
Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months The patients were divided into two equal groups.
| Study group | Role | What they receive |
|---|---|---|
| Group I (bar locator): Patients were given overdentures with bar locator attachments | Experimental | Group I received mandibular overdentures with a bar locator attachment , specially designed milled bar with parallel walls was built for this group, and two holes were drilled in the top surface of the bar using a 1.7 mm bar drill to create the threaded site in the waxed bar, followed by a 2.0 mm bar tap. The locator female component was then connected to the corresponding site using a customised rider. Receives: Other: overdenture |
| group2, Patients were given overdentures with bar clip attachment. | Experimental | bar clip attachment. Patients received mandibular overdentures with bar clip attachments. A plastic prefabricated bar was cast in cobalt-chrome alloy. Group II patients received mandibular overdentures with bar clip attachments. A plastic prefabricated bar was cast in cobalt-chrome alloy. Receives: Other: overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
Patient Satisfaction
Measured: Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.
prosthetic complications
Measured: Mechanical complications were clinically examined and included Distortion /wear of retentive components, Bar screw loosening, Fracture of opposing prosthesis, Teeth wear, Fracture at the midline of the prosthesis and Teeth separation within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start12 Nov 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT06673186
- Sponsor's protocol ID
- M21011122
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 4 Nov 2024
- 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 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Prosthetic Complications of Bar Locator Versus Bar Clip Attachments for Mandibular Two-Implant Overdentures
- ClinicalTrials.gov ID
- NCT06673186
- Acronym / sponsor ID
- M21011122
- Conditions
- Edentulism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 Nov 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 4 Nov 2024 (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.
Purpose: This study evaluated patient satisfaction and oral health-related- quality of life (OHRQoL) with implant overdentures retained with bar locator versus bar clip attachment for mandibular two-implant overdentures. Materials and methods: This study included sixteen edentulous patients. Every patient received new maxillary and mandibular dentures. Two dental implants have been embedded in the mandibular canine areas. The participants were randomly divided into two equal groups: Group I (bar locator): Patients were given overdentures with bar locator attachments, Group II (bar clip): Patients were given overdentures with bar clip attachment. Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.
The aim of this study was to document and report on the prosthetic complications associated with mandibular implant overdentures using bar locator and bar clip attachments. The study aimed to test the null hypothesis that the complications would not differ based on the type of retention (locator or clip).
Study design
- Primary purpose
- Health services research
- 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 | Experimental | Other: overdentureGroup I received mandibular overdentures with a bar locator attachment , specially designed milled bar with parallel walls was built for this group, and two holes were drilled in the top surface of the bar using a 1.7 mm bar drill to create the threaded site in the waxed bar, followed by a 2.0 mm bar tap. The locator female component was then connected to the corresponding site using a customised rider. |
| group2, Patients were given overdentures with bar clip attachment. | Experimental | Other: overdenturebar clip attachment. Patients received mandibular overdentures with bar clip attachments. A plastic prefabricated bar was cast in cobalt-chrome alloy. Group II patients received mandibular overdentures with bar clip attachments. A plastic prefabricated bar was cast in cobalt-chrome alloy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Each patient had sufficient remaining alveolar ridge in the upper and lower jaw to support implants in the lower jaw area
- a minimum length of 11 mm and a diameter of 3.7 mm, as confirmed by cone beam computed tomography.
- patient had a class I jaw relationship
- adequate space between the arches.
- healthy, firm gum tissue.
Key exclusion criteria (4 listed)
- participants with uncontrolled diabetes,
- heavy smoking
- drinking habits
- temporomandibular joint (TMJ) issues.
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 |
|---|---|---|
| overdenturePatient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months The patients were divided into two equal groups. | Other | Group I (bar locator): Patients were given overdentures with bar locator attachments, group2, Patients were given overdentures with bar clip attachment. |
Primary outcome
Patient Satisfaction
Time frame: Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.
Patient Satisfaction
prosthetic complications
Time frame: Mechanical complications were clinically examined and included Distortion /wear of retentive components, Bar screw loosening, Fracture of opposing prosthesis, Teeth wear, Fracture at the midline of the prosthesis and Teeth separation within 5 years
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 4 Nov 2024.
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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 overdenture 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 5 inclusion and 4 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 4 Nov 2024. 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 Satisfaction (time frame: Patient satisfaction (primary outcome) was measured by a visual analog scale (VAS). OHRQoL (secondary outcome) was measured by oral health impact profile (OHIP-14). Questions of VAS and OHIP-14 were evaluated after 3 months.). 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 4 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.