Edentulous Alveolar Ridge In MandibleNCT07250503
Compare the Difference in Occlusal Force Distribution and Denture Retention Using 2 Different Denture Base Materials in Implant Retained Overdenture
A study testing Conventional acrylic resin denture and Flexible resin denture in people with Edentulous Alveolar Ridge In Mandible and Complete Edentulism, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The global increase in the aging population has led to a rise in total edentulism, which remains a major public health concern. two-implant-retained mandibular overdentures have been regarded as the standard of care, offering superior retention, stability, comfort, and masticatory efficiency compared to conventional… 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 In Mandible, Complete Edentulism, Dental Implant
- What is being tested?
- Conventional acrylic resin denture and Flexible resin denture
- 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 Sep 2024to 1 Feb 2026
- 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: Impact of Wearing Two Different Implant Retained Mandibular Overdentures on Occlusal Force Distribution and Denture Retention (Randomized Clinical Trial)
The global increase in the aging population has led to a rise in total edentulism, which remains a major public health concern. two-implant-retained mandibular overdentures have been regarded as the standard of care, offering superior retention, stability, comfort, and masticatory efficiency compared to conventional dentures. Among available attachment systems-bar, ball, stud, and magnet-the Equator attachment has gained popularity due to its low vertical profile, suitability for limited inter-occlusal space, and ease of handling.
Assessment of masticatory performance and occlusal balance can be objectively measured using devices such as bite force analyzers and the computerized T-Scan system, which quantifies occlusion and disocclusion times.
Conventional heat-cured polymethyl methacrylate (PMMA) remains the most widely used denture base material; however, it has mechanical and biological limitations. Flexible denture base materials have been introduced to overcome these drawbacks by enhancing adaptation, distributing occlusal loads more evenly, and improving comfort and retention.
Read the detailed description
24 Patients will be randomly and equally divided into two treatment groups:
- Group 1: Each patient in this group will receive conventional maxillary and mandibular complete dentures made of heat-cured acrylic resin PMMA. In the mandible, two implants were inserted in the symphyseal area and retained by equator attachments.
- Group 2: Patients in this group received the same type of treatment as the patients in group 1, but the mandibular overdentures were made of the flexible acrylic resin "breflex" The present study will be performed to compare the difference in retention, occlusal force distribution, occlusion and disocclusion time, and bite force for implant retained mandibular over denture using PMMA and flexible dentures base materials
- Conditions
- Edentulous Alveolar Ridge In Mandible, Complete Edentulism, Dental Implant, Attachments, Implant Retained Overdenture, Edentulous Mouth
- Being tested
- Conventional acrylic resin denture, Flexible resin denture
- Keywords
- Completely edentulous patients, Dental Implants, Edentulous Ridge
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional acrylic resin dentureProcedure or surgery
Mandibular complete dentures made of heat-cured acrylic resin (PMMA). In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments.
Flexible resin dentureProcedure or surgery
Mandibular overdentures were made of the flexible acrylic resin breflex, In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments
| Study group | Role | What they receive |
|---|---|---|
| Mandibular complete dentures processed into heat cured acrylic resin | Active comparator | Mandibular complete dentures made of heat-cured acrylic resin (PMMA). In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments. Receives: Procedure: Conventional acrylic resin denture |
| Mandibular thermoplastic nylon denture | Experimental | Mandibular overdentures were made of the flexible acrylic resin breflex, In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments. Receives: Procedure: Flexible resin denture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusal force distribution
Occlusal force distribution will be measured by T-Scan, The latest version (T-Scan III) provides a dynamic visual evaluation of a patient's occlusion from initial tooth contact to maximum intercuspation. The system records relative force values and allows objective quantitative evaluation of occlusal balance by recording numerical values for occlusion and disocclusion times
Measured: Follow up visits were scheduled at denture insertion, 6, and 12 months
Secondary outcomes (4)
Retention of lower denture
Retention of lower denture will be measured using digital force gauge, 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: Follow up visits were scheduled at denture insertion, 6, and 12 months
occlusion time
occlusion and disocclusion time will be measured by T-Scan, The latest version (T-Scan III) provides a dynamic visual evaluation of a patient's occlusion from initial tooth contact to maximum intercuspation. The system records relative force values and allows objective quantitative evaluation of occlusal balance by recording numerical values for occlusion times
Measured: Follow up visits were scheduled at denture insertion, 6, and 12 months
Biting force
Biting force will be measured by bite force meter
Measured: Follow up visits were scheduled at denture insertion, 6, and 12 months
Disocclusion time
will be measured by T-Scan, The latest version (T-Scan III) provides a dynamic visual evaluation of a patient's occlusion from initial tooth contact to maximum intercuspation. The system records relative force values and allows objective quantitative evaluation of occlusal balance by recording numerical values for disocclusion times
Measured: Follow up visits were scheduled at denture insertion, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Sep 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
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
- NCT07250503
- Sponsor's protocol ID
- 28.4.24
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- 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 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Wearing Two Different Implant Retained Mandibular Overdentures on Occlusal Force Distribution and Denture Retention (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07250503
- Acronym / sponsor ID
- 28.4.24
- Conditions
- Edentulous Alveolar Ridge In Mandible, Complete Edentulism, Dental Implant, Attachments, Implant Retained Overdenture, Edentulous Mouth
- Keywords
- Completely edentulous patients, Dental Implants, Edentulous Ridge
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 26 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.
The global increase in the aging population has led to a rise in total edentulism, which remains a major public health concern. two-implant-retained mandibular overdentures have been regarded as the standard of care, offering superior retention, stability, comfort, and masticatory efficiency compared to conventional dentures. Among available attachment systems-bar, ball, stud, and magnet-the Equator attachment has gained popularity due to its low vertical profile, suitability for limited inter-occlusal space, and ease of handling.
Assessment of masticatory performance and occlusal balance can be objectively measured using devices such as bite force analyzers and the computerized T-Scan system, which quantifies occlusion and disocclusion times.
Conventional heat-cured polymethyl methacrylate (PMMA) remains the most widely used denture base material; however, it has mechanical and biological limitations. Flexible denture base materials have been introduced to overcome these drawbacks by enhancing adaptation, distributing occlusal loads more evenly, and improving comfort and retention.
Detailed description
24 Patients will be randomly and equally divided into two treatment groups:
- Group 1: Each patient in this group will receive conventional maxillary and mandibular complete dentures made of heat-cured acrylic resin PMMA. In the mandible, two implants were inserted in the symphyseal area and retained by equator attachments.
- Group 2: Patients in this group received the same type of treatment as the patients in group 1, but the mandibular overdentures were made of the flexible acrylic resin "breflex" The present study will be performed to compare the difference in retention, occlusal force distribution, occlusion and disocclusion time, and bite force for implant retained mandibular over denture using PMMA and flexible dentures base materials
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mandibular complete dentures processed into heat cured acrylic resin | Active comparator | Procedure: Conventional acrylic resin dentureMandibular complete dentures made of heat-cured acrylic resin (PMMA). In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments. |
| Mandibular thermoplastic nylon denture | Experimental | Procedure: Flexible resin dentureMandibular overdentures were made of the flexible acrylic resin breflex, In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments. |
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 |
|---|---|---|
| Conventional acrylic resin dentureMandibular complete dentures made of heat-cured acrylic resin (PMMA). In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments. | Procedure or surgery | Mandibular complete dentures processed into heat cured acrylic resin |
| Flexible resin dentureMandibular overdentures were made of the flexible acrylic resin breflex, In the mandible, two implants were inserted in the symphyseal area and retained by Equator attachments | Procedure or surgery | Mandibular thermoplastic nylon denture |
Primary outcome
Occlusal force distribution
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
Occlusal force distribution will be measured by T-Scan, The latest version (T-Scan III) provides a dynamic visual evaluation of a patient's occlusion from initial tooth contact to maximum intercuspation. The system records relative force values and allows objective quantitative evaluation of occlusal balance by recording numerical values for occlusion and disocclusion times
4 secondary outcomes
Retention of lower denture
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
occlusion time
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
Biting force
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
Disocclusion time
Time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months
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 26 Nov 2025.
- Individual participant dataSharing planned: Yes. Study Protocol and Clinical Study Report
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Clinical Effects of Keratinized Mucosa Augmentation Around Dental Implant With Free Gingival Graft in Different Surgical Timing at Mandibular Posterior Sites
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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 Conventional acrylic resin denture and Flexible resin denture 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: under way, not looking for participants, as of the sponsor's last update on 26 Nov 2025. 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?
Occlusal force distribution (time frame: Follow up visits were scheduled at denture insertion, 6, and 12 months). 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 26 Nov 2025.