Edentulous Alveolar RidgeNCT06678945
Using Two Different Attachments in Mandibular Implant Overdenture Cases in Order to Retention and Patient Satisfaction
A study testing Bar-Clip attachment and Bar- OT Equator attachment in people with Edentulous Alveolar Ridge and Complete Edentulism, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The Goal of the clinical trail is to evaluate the efficacy of Bar- OT Equator attachment on retention and patient satisfaction in comparison to the standard technique using Bar- clip attachment. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge, Complete Edentulism, Dental Implant
- What is being tested?
- Bar-Clip attachment and Bar- OT Equator attachment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 Feb 2025
- 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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients age must range from 60- 70 years old.
- All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
- Patients should be free from any metabolic or bone disorder that contraindicate implant installation.
- All patients must have sufficient inter arch space
Who cannot join
- Patients with oral or systemic diseases.
- Patients with xerostomia or excessive salivation.
- Patients with parafunctional habits (bruxism or clenching).
- Heavy smoker or alcoholic patients.
- Patients with history of temporo-mandibular dysfunction.
- Patients with brain disorders or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Two Different Attachments Retaining Mandibular Implant Overdenture Regarding Retention and Patient Satisfaction (Randomized Clinical Trail)
The Goal of the clinical trail is to evaluate the efficacy of Bar- OT Equator attachment on retention and patient satisfaction in comparison to the standard technique using Bar- clip attachment.
Patients will visit the clinic after the surgery and after the attachment insertion for check ups and during the follow up periods ( at denture insertion, 3 months and 6 months)
Read the detailed description
patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be divided into two equal groups; Group I will be retained by Bar-Clip attachment, while Group II will be retained by Bar- OT Equator attachment. Both groups will be functionally loaded after three months of insertion.
Retention of lower denture will be measured using digital force gauge and Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire. All parameters will be measured at denture insertion, 3 month, and 6 month later.
- Conditions
- Edentulous Alveolar Ridge, Complete Edentulism, Dental Implant, Attachments, Implant Supported Overdenture, Edentulous Mouth
- Being tested
- Bar-Clip attachment, Bar- OT Equator attachment
- Keywords
- Dental Implants, Completely edentulous patients, Edentulous Ridge
- Medical subject headings
- Mouth, Edentulous, Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bar-Clip attachmentProcedure or surgery
The 2 implants will be connected with bar attachments while the denture will be retained over the bar using clip.
Bar- OT Equator attachmentProcedure or surgery
The 2 implants will be connected with bar attachments while the denture will be retained over the bar using the OT Equator.
| Study group | Role | What they receive |
|---|---|---|
| Bar-Clip attachment | Active comparator | on the 2nd stage, implants will be loaded with bar-clip attachments to support overdenture Receives: Procedure: Bar-Clip attachment |
| Bar- OT Equator attachment | Experimental | on the 2nd stage, implants will be loaded with Bar- OT Equator attachments to support overdenture Receives: Procedure: Bar- OT Equator attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Retention will be measured using digital force gauge A digital force meter was used to measure denture resistance to vertical displacement (i.e., retention) by applying a pulling force on a metal hook located in the geometric center of each mandibular conventional denture that was identified on the lower cast at the intersection of three lines bisecting the angles of the triangle, formed by both retromolar pads and the midline.
Measurement of mandibular denture retention:
The patient was instructed to place his head on chin rest and occlusal plane was set parallel to the floor. Tongue freedom was checked then and three minutes seating time was allowed before taking the measurements. A vertical pulling force was applied using the metallic probe of the digital force-meter that was attached to the hook present at the geometric center of mandibular denture. Average value of six readings was recorded.
Measured: it will be measured at denture insertion, 3 month, and 6 month later
Secondary outcomes (1)
Patient satisfaction
Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire, which included subjective parameters such as initial adaptability, post insertion problems, aesthetics, masticatory ability, speech, retention. Patients were asked to respond to questions given in the questionnaire
Measured: it will be measured at denture insertion, 3 month, and 6 month later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 May 2024
- Primary completion1 Jul 2024
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar RidgeStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Taha Kamel Taha Alloush, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678945
- Sponsor's protocol ID
- 27 4 24
- Status last verified
- Dec 2024
- First submitted
- 6 Nov 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Clinical Study Report
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Different Attachments Retaining Mandibular Implant Overdenture Regarding Retention and Patient Satisfaction (Randomized Clinical Trail)
- ClinicalTrials.gov ID
- NCT06678945
- Acronym / sponsor ID
- 27 4 24
- Conditions
- Edentulous Alveolar Ridge, Complete Edentulism, Dental Implant, Attachments, Implant Supported Overdenture, Edentulous Mouth
- Keywords
- Dental Implants, Completely edentulous patients, Edentulous Ridge
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 7 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.
The Goal of the clinical trail is to evaluate the efficacy of Bar- OT Equator attachment on retention and patient satisfaction in comparison to the standard technique using Bar- clip attachment.
Patients will visit the clinic after the surgery and after the attachment insertion for check ups and during the follow up periods ( at denture insertion, 3 months and 6 months)
Detailed description
patients will receive upper complete dentures and lower complete overdentures. The upper complete denture will be mucosa supported and the lower complete denture will be supported and retained for all patients by two dental implants in the inter-foraminal region. Patients will be divided into two equal groups; Group I will be retained by Bar-Clip attachment, while Group II will be retained by Bar- OT Equator attachment. Both groups will be functionally loaded after three months of insertion.
Retention of lower denture will be measured using digital force gauge and Patient satisfaction was evaluated with a standard 5-point Liker scale questionnaire. All parameters will be measured at denture insertion, 3 month, and 6 month later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bar-Clip attachment | Active comparator | Procedure: Bar-Clip attachmenton the 2nd stage, implants will be loaded with bar-clip attachments to support overdenture |
| Bar- OT Equator attachment | Experimental | Procedure: Bar- OT Equator attachmenton the 2nd stage, implants will be loaded with Bar- OT Equator attachments to support overdenture |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All patients age must range from 60- 70 years old.
- All patients' ridges should be covered with firm mucosa free from any signs of inflammation or ulceration and exhibit adequate height and width of the residual alveolar ridge.
- Patients should be free from any metabolic or bone disorder that contraindicate implant installation.
- All patients must have sufficient inter arch space
Key exclusion criteria (6 listed)
- Patients with oral or systemic diseases.
- Patients with xerostomia or excessive salivation.
- Patients with parafunctional habits (bruxism or clenching).
- Heavy smoker or alcoholic patients.
- Patients with history of temporo-mandibular dysfunction.
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-Clip attachmentThe 2 implants will be connected with bar attachments while the denture will be retained over the bar using clip. | Procedure or surgery | Bar-Clip attachment |
| Bar- OT Equator attachmentThe 2 implants will be connected with bar attachments while the denture will be retained over the bar using the OT Equator. | Procedure or surgery | Bar- OT Equator attachment |
Primary outcome
Retention
Time frame: it will be measured at denture insertion, 3 month, and 6 month later
Retention will be measured using digital force gauge A digital force meter was used to measure denture resistance to vertical displacement (i.e., retention) by applying a pulling force on a metal hook located in the geometric center of each mandibular conventional denture that was identified on the lower cast at the intersection of three lines bisecting the angles of the triangle, formed by both retromolar pads and the midline. Measurement of mandibular denture retention: The patient was instructed to place his head on chin rest and occlusal plane was set parallel to the floor. Tongue freedom was checked then and three minutes seating time was allowed before taking the measurements. A vertical pulling force was applied using the metallic probe of the digital force-meter that was attached to the hook present at the geometric center of mandibular denture. Average value of six readings was recorded.
1 secondary outcome
Patient satisfaction
Time frame: it will be measured at denture insertion, 3 month, and 6 month later.
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 16 Dec 2024.
- Individual participant dataSharing planned: Yes. Study Protocol and Clinical Study Report
Related trials for Edentulous Alveolar Ridge
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Two-piece Zirconia Implants With Two Various Platforms
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Crestal Bone Loss Around Narrow Diameter Implants Versus Standard Diameter Implants With Bone Augmentation in Horizontally Deficient Posterior Mandibular Sites.
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Compare the Difference in Occlusal Force Distribution and Denture Retention Using 2 Different Denture Base Materials in Implant Retained Overdenture
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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 Bar-Clip attachment and Bar- OT Equator attachment in people with Edentulous Alveolar Ridge and Complete Edentulism, run by Al-Azhar 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 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?
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?
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?
Retention (time frame: it will be measured at denture insertion, 3 month, and 6 month later). 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 16 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.