Edentulous Alveolar Ridge In MandibleNCT07241481
Using Two Different Attachments (Equator Vs Ball and Sockets) Retaining Mandibular Implant Overdenture in Order to See Bone Changes and Occlusal Force Distribution
A study testing Ball & Socket Attachment and Equator Attachment in people with Edentulous Alveolar Ridge In Mandible and Complete Edentulism, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Alveolar ridge resorption is an unavoidable consequence in complete denture wearers due to limited retention and stability. Implant-retained overdentures enhance retention, stability, and masticatory performance while reducing ridge resorption and improving patients' quality of life. Read more about this study
- Who is it for?
- Ages 55 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge In Mandible, Complete Edentulism, Dental Implant
- What is being tested?
- Ball & Socket Attachment and Equator Attachment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Dec 2025
- 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 55 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patients age must range from 55- 60 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.
Egypt1 site
Oral and Dental Research Institute, National Research Center
Cairo, 4470351
About this study
Official title: Comparing Two Different Attachments Retaining Mandibular Implant Overdenture Regarding Bone Changes and Occlusal Force Distribution (Randomized Clinical Trial)
Alveolar ridge resorption is an unavoidable consequence in complete denture wearers due to limited retention and stability. Implant-retained overdentures enhance retention, stability, and masticatory performance while reducing ridge resorption and improving patients' quality of life.
Among attachment systems, ball-type anchors have long been favored for their simplicity and cost-effectiveness. However, the Equator attachment has emerged as a refined alternative, providing superior retention and stability for implant overdentures.
Functional performance can be evaluated through electromyography, which records masticatory muscle activity, and the T-Scan system, which analyzes occlusal force distribution and timing during dynamic occlusion. Additionally, bite force measurement serves as a key indicator of prosthetic efficiency and neuromuscular function, with implant-retained overdentures showing higher values than conventional dentures. This study aimed to compare bone level changes, occlusal force distribution in patients wearing mandibular implant overdentures retained by Equator and ball-and-socket attachments.
Read the detailed description
All 24 patients will receive upper complete and lower complete overdentures. The upper complete denture will be mucosa supported while lower complete denture will be retained for by two dental implants in the inter-foraminal region. Patients will be divided into two equal groups; Group I will be retained by Ball and Socket attachment, while Group II will be retained by Equator attachment. Both groups will be functionally loaded after three months of insertion. This study aimed to compare bone level changes, occlusal force distribution in patients wearing mandibular implant overdentures retained by Equator and ball-and-socket attachments. Bone level changes will be measured using CBCT, While occlusal force will be measured using Tscan system.
- Conditions
- Edentulous Alveolar Ridge In Mandible, Complete Edentulism, Dental Implant, Attachments, Implant Retained Overdenture, Edentulous Jaw
- Being tested
- Ball & Socket Attachment, Equator Attachment
- Keywords
- Dental Implants, Attachments, Edentulous Ridge
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ball & Socket AttachmentProcedure or surgery
Two implants will be restored using ball-and-socket attachment systems, with the mandibular denture retained over these attachments through corresponding metal housings
Equator AttachmentProcedure or surgery
Two implants will be restored using Equator attachment systems, with the mandibular denture retained over these attachments through corresponding metal housings
| Study group | Role | What they receive |
|---|---|---|
| Ball & Socket Attachment | Active comparator | On the 2nd stage, implants will be loaded with ball \& socket attachments to retain overdenture Receives: Procedure: Ball & Socket Attachment |
| Equator Attachment | Experimental | On the 2nd stage, implants will be loaded with Equator attachments to retain overdenture Receives: Procedure: Equator Attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal Bone Changes
Marginal bone height changes around the two implants were evaluated through the software by measuring the distance from the alveolar crest to the implant apex in both coronal and sagittal views. The amount of bone loss was calculated by subtracting the measured distance between each radiographic evaluation made at the time of denture insertion and the recall appointments by superimposition of images and average was taken
Measured: it will be measured at denture insertion, 6 month, and 12 month later
Secondary outcomes (1)
Occlusal force distribution measurement
Occlusal force distribution was done using the T-Scan™ Novus™, which consists of a sensor registering occlusal contacts, a data transferring module linked to a computer, and a software program to send data to the computer and visualize them on the monitor
Measured: it will be recorded at the time of prosthesis insertion, 6 months, and 12 months after denture insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Jul 2024
- Primary completion1 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous Alveolar Ridge In 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 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
- NCT07241481
- Sponsor's protocol ID
- 03410625
- Status last verified
- Apr 2026
- First submitted
- 17 Nov 2025
- Last updated
- 2 Apr 2026
- 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 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Different Attachments Retaining Mandibular Implant Overdenture Regarding Bone Changes and Occlusal Force Distribution (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07241481
- Acronym / sponsor ID
- 03410625
- Conditions
- Edentulous Alveolar Ridge In Mandible, Complete Edentulism, Dental Implant, Attachments, Implant Retained Overdenture, Edentulous Jaw
- Keywords
- Dental Implants, Attachments, Edentulous Ridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 21 Nov 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.
Alveolar ridge resorption is an unavoidable consequence in complete denture wearers due to limited retention and stability. Implant-retained overdentures enhance retention, stability, and masticatory performance while reducing ridge resorption and improving patients' quality of life.
Among attachment systems, ball-type anchors have long been favored for their simplicity and cost-effectiveness. However, the Equator attachment has emerged as a refined alternative, providing superior retention and stability for implant overdentures.
Functional performance can be evaluated through electromyography, which records masticatory muscle activity, and the T-Scan system, which analyzes occlusal force distribution and timing during dynamic occlusion. Additionally, bite force measurement serves as a key indicator of prosthetic efficiency and neuromuscular function, with implant-retained overdentures showing higher values than conventional dentures. This study aimed to compare bone level changes, occlusal force distribution in patients wearing mandibular implant overdentures retained by Equator and ball-and-socket attachments.
Detailed description
All 24 patients will receive upper complete and lower complete overdentures. The upper complete denture will be mucosa supported while lower complete denture will be retained for by two dental implants in the inter-foraminal region. Patients will be divided into two equal groups; Group I will be retained by Ball and Socket attachment, while Group II will be retained by Equator attachment. Both groups will be functionally loaded after three months of insertion. This study aimed to compare bone level changes, occlusal force distribution in patients wearing mandibular implant overdentures retained by Equator and ball-and-socket attachments. Bone level changes will be measured using CBCT, While occlusal force will be measured using Tscan system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ball & Socket Attachment | Active comparator | Procedure: Ball & Socket AttachmentOn the 2nd stage, implants will be loaded with ball \& socket attachments to retain overdenture |
| Equator Attachment | Experimental | Procedure: Equator AttachmentOn the 2nd stage, implants will be loaded with Equator attachments to retain overdenture |
Who may qualify
- Ages
- 55 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All patients age must range from 55- 60 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 |
|---|---|---|
| Ball & Socket AttachmentTwo implants will be restored using ball-and-socket attachment systems, with the mandibular denture retained over these attachments through corresponding metal housings | Procedure or surgery | Ball & Socket Attachment |
| Equator AttachmentTwo implants will be restored using Equator attachment systems, with the mandibular denture retained over these attachments through corresponding metal housings | Procedure or surgery | Equator Attachment |
Primary outcome
Marginal Bone Changes
Time frame: it will be measured at denture insertion, 6 month, and 12 month later
Marginal bone height changes around the two implants were evaluated through the software by measuring the distance from the alveolar crest to the implant apex in both coronal and sagittal views. The amount of bone loss was calculated by subtracting the measured distance between each radiographic evaluation made at the time of denture insertion and the recall appointments by superimposition of images and average was taken
1 secondary outcome
Occlusal force distribution measurement
Time frame: it will be recorded at the time of prosthesis insertion, 6 months, and 12 months after denture insertion.
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 2 Apr 2026.
- Individual participant dataSharing planned: Yes. Study Protocol and Clinical Study Report
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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 Ball & Socket Attachment and Equator Attachment in people with Edentulous Alveolar Ridge In Mandible 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: finished, as of the sponsor's last update on 2 Apr 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?
Marginal Bone Changes (time frame: it will be measured at denture insertion, 6 month, and 12 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 2 Apr 2026.