Edentulism in Lower JawEvaluationNCT07262307
Evaluation of PEEK Versus Titanium Bar Attachments With Implant Assisted Mandibular Complete Overdenture Fabricated by CAD/CAM Technology
A study testing implant overdenture in people with Edentulism in Lower Jaw, run by Tanta University at 1 site in Egypt.
Trial summary
Evaluation of PEEK versus Titanium Bar Attachments with Implant Assisted Mandibular Complete Overdenture fabricated by CAD/CAM Technology measuring retention of the overdenture and implant evaluation for 6 months and one year Read more about this study
- Who is it for?
- Ages 45 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Edentulism in Lower Jaw
- What is being tested?
- implant overdenture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2024to 28 Apr 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 45 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Completely edentulous patients free from systemic diseases that may affect soft or hard tissue healing.
- Patient's age ranges from 40 to 60 years old.
- The bone quality and quantity of the mandibular alveolar ridge must fulfill the criteria for implant placement.
- They have normal class Ӏ maxilla-mandibular relationship and sufficient inter-arch space with at least 25mm for bar attachment.
- They have good oral hygiene.
Who cannot join
- Systemic disorders that may influence soft or hard tissue healing as oral diseases.
- Patients with history of radiation therapy in the head and neck region.
- Patients with neurological or psychological problems that may impair good oral hygiene.
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of PEEK versus Titanium Bar Attachments with Implant Assisted Mandibular Complete Overdenture fabricated by CAD/CAM Technology measuring retention of the overdenture and implant evaluation for 6 months and one year
- Conditions
- Edentulism in Lower Jaw
- Being tested
- implant overdenture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implant overdentureDevice
using of CAD/CAM with new material and digital fabrication techniques
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of PEEK material | Experimental | digital fabrications techniques Receives: Device: implant overdenture |
| Group Ӏ (control group): Six patients will receive digital mandibular implant overdenture assisted b | Active comparator | • Clinical evaluation Receives: Device: implant overdenture |
| PEEK group new material | Experimental | Not described Receives: Device: implant overdenture |
| PEEK material study group | Experimental | Not described Receives: Device: implant overdenture |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention of mandibular overdenture
Retention of the mandibular implant-assisted complete overdenture will be measured using a digital force meter. Measurements will be taken at 6 months and 12 months after denture insertion.
Measured: 6 months and 12 months post-insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start30 May 2024
- Primary completion23 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulism in Lower JawStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nour Elhouda, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262307
- Sponsor's protocol ID
- 2140
- Acronym
- Evaluation
- Status last verified
- Oct 2026
- First submitted
- 7 Sep 2025
- Last updated
- 7 Oct 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PEEK Versus Titanium Bar Attachments With Implant Assisted Mandibular Complete Overdenture Fabricated by CAD/CAM Technology
- ClinicalTrials.gov ID
- NCT07262307
- Acronym / sponsor ID
- Evaluation / 2140
- Conditions
- Edentulism in Lower Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 3 Dec 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.
Evaluation of PEEK versus Titanium Bar Attachments with Implant Assisted Mandibular Complete Overdenture fabricated by CAD/CAM Technology measuring retention of the overdenture and implant evaluation for 6 months and one year
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Evaluation of PEEK material | Experimental | Device: implant overdenturedigital fabrications techniques |
| Group Ӏ (control group): Six patients will receive digital mandibular implant overdenture assisted b | Active comparator | Device: implant overdenture• Clinical evaluation |
| PEEK group new material | Experimental | Device: implant overdenture |
| PEEK material study group | Experimental | Device: implant overdenture |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Completely edentulous patients free from systemic diseases that may affect soft or hard tissue healing.
Key exclusion criteria (3 listed)
- Systemic disorders that may influence soft or hard tissue healing as oral diseases.
- Patients with history of radiation therapy in the head and neck region.
- Patients with neurological or psychological problems that may impair good oral hygiene.
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 |
|---|---|---|
| implant overdentureusing of CAD/CAM with new material and digital fabrication techniques | Device | Evaluation of PEEK material, Group Ӏ (control group): Six patients will receive digital mandibular implant overdenture assisted b, PEEK group new material, PEEK material study group |
Primary outcome
retention of mandibular overdenture
Time frame: 6 months and 12 months post-insertion
Retention of the mandibular implant-assisted complete overdenture will be measured using a digital force meter. Measurements will be taken at 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 7 Oct 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 implant overdenture in people with Edentulism in Lower Jaw, run by Tanta 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 3 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 7 Oct 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?
retention of mandibular overdenture (time frame: 6 months and 12 months post-insertion). 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 7 Oct 2026.