ProsthodonticsNCT07475507
Effect of PEEK and Titanium Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles
A study testing Titanium framework reinforced all on four prosthesis and PEEK framework reinforced all on four prosthesis in people with Prosthodontics and Implants, Dental, run by Cairo University at 1 site in Egypt.
Trial summary
A fixed all-on-four prosthesis will be constructed for the lower arch for each patient and the marginal bone loss will be evaluated at baseline, 3,6,9 and 12 months. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Prosthodontics, Implants, Dental, Prosthesis
- What is being tested?
- Titanium framework reinforced all on four prosthesis and PEEK framework reinforced all on four prosthesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to Mar 2027
- 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 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completely edentulous patients requesting a fixed, implant supported restoration.
- Patients aged from 45 to 60, able to sign an informed consent will be considered eligible for this trial.
- Implant sites must allow the placement of four implants.
- Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)
- In case of post-extraction sites, they must have been healed for at least 3 months before being treated in the study.
- Patients with no systemic condition that may interfere with implant placement (e.g., Immunosuppressed or immunocompromised patients, patients under treatment of intravenous amino-bisphosphonates)
- -
Who cannot join
- Patients with poor oral hygiene and motivation.
- Female patients taking any medical treatment for management of osteoporosis.
- Drug abusers.
- Psychiatric problems or unrealistic expectations.
- Patients with active infection or inflammation in the planned implant area at the time of implant placement.
- Immuno-compromised patients (Diabetic with HBA1C > 7 or patients undergoing chemo or radiotherapy or bisphosphonates)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate, 11251
About this study
Official title: Effect of PEEK and Titanium Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles. A Randomized Controlled Clinical Trial
A fixed all-on-four prosthesis will be constructed for the lower arch for each patient and the marginal bone loss will be evaluated at baseline, 3,6,9 and 12 months.
- Conditions
- Prosthodontics, Implants, Dental, Prosthesis, Bone Loss, Alveolar
- Being tested
- Titanium framework reinforced all on four prosthesis, PEEK framework reinforced all on four prosthesis
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium framework reinforced all on four prosthesisOther
Titanium frameworks provided many advantages as their biocompatibility, corrosion resistance, relatively lower weight and high mechanical properties as well as avoiding the casting errors and technique sensitivity
PEEK framework reinforced all on four prosthesisOther
Fabricating a fixed prosthesis for patients with completely edentulous mandibles reinforced with PEEK
| Study group | Role | What they receive |
|---|---|---|
| Titanium framework reinforced all on four prosthesis | Other | Active Comparator: Titanium reinforced fixed all-on-four prosthesis Receives: Other: Titanium framework reinforced all on four prosthesis |
| PEEK framework reinforced all on four prosthesis | Other | Not described Receives: Other: PEEK framework reinforced all on four prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Marginal bone loss
Marginal bone loss around each dental implant using parallel technique in digital periodical radiographs which will be measured in mm from the crestal bone level at the implant platform.
Measured: 12 months at intervals (0,3,6,9and 12 months)
Secondary outcomes (1)
Bone density
Bone density around dental implants will be measured using digora digital radiographs which will be measured in hounsfield units.
Measured: 12 months at intervals (0,3,6,9and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start1 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProsthodonticsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 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
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Hamed Khalaf, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475507
- Sponsor's protocol ID
- AO4-PEEKTi-MBL
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Araujo Nobre M, Moura Guedes C, Almeida R, Silva A, Sereno N. Hybrid Polyetheretherketone (PEEK)-Acrylic Resin Prostheses and the All-on-4 Concept: A Full-Arch Implant-Supported Fixed Solution with 3 Years of Follow-Up. J Clin Med. 2020 Jul 10;9(7):2187. doi: 10.3390/jcm9072187.
PubMed 32664393
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PEEK and Titanium Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07475507
- Acronym / sponsor ID
- AO4-PEEKTi-MBL
- Conditions
- Prosthodontics, Implants, Dental, Prosthesis, Bone Loss, Alveolar
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 16 Mar 2026 (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.
A fixed all-on-four prosthesis will be constructed for the lower arch for each patient and the marginal bone loss will be evaluated at baseline, 3,6,9 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium framework reinforced all on four prosthesis | Other | Other: Titanium framework reinforced all on four prosthesisActive Comparator: Titanium reinforced fixed all-on-four prosthesis |
| PEEK framework reinforced all on four prosthesis | Other | Other: PEEK framework reinforced all on four prosthesis |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Completely edentulous patients requesting a fixed, implant supported restoration.
- Patients aged from 45 to 60, able to sign an informed consent will be considered eligible for this trial.
- Implant sites must allow the placement of four implants.
- Non- heavy Smokers will be included (smoking up to 10 cigarettes/day)
- In case of post-extraction sites, they must have been healed for at least 3 months before being treated in the study.
Key exclusion criteria (6 listed)
- Patients with poor oral hygiene and motivation.
- Female patients taking any medical treatment for management of osteoporosis.
- Drug abusers.
- Psychiatric problems or unrealistic expectations.
- Patients with active infection or inflammation in the planned implant area at the time of implant placement.
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 |
|---|---|---|
| Titanium framework reinforced all on four prosthesisTitanium frameworks provided many advantages as their biocompatibility, corrosion resistance, relatively lower weight and high mechanical properties as well as avoiding the casting errors and technique sensitivity | Other | Titanium framework reinforced all on four prosthesis |
| PEEK framework reinforced all on four prosthesisFabricating a fixed prosthesis for patients with completely edentulous mandibles reinforced with PEEK | Other | PEEK framework reinforced all on four prosthesis |
Primary outcome
Marginal bone loss
Time frame: 12 months at intervals (0,3,6,9and 12 months)
Marginal bone loss around each dental implant using parallel technique in digital periodical radiographs which will be measured in mm from the crestal bone level at the implant platform.
1 secondary outcome
Bone density
Time frame: 12 months at intervals (0,3,6,9and 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 16 Mar 2026.
- Results publication: PubMed 32664393de Araujo Nobre M, Moura Guedes C, Almeida R, Silva A, Sereno N. Hybrid Polyetheretherketone (PEEK)-Acrylic Resin Prostheses and the All-on-4 Concept: A Full-Arch Implant-Supported Fixed Solution with 3 Years of Follow-Up. J Clin Med. 2020 Jul 10;9(7):2187. doi: 10.3390/jcm9072187.
- Individual participant dataSharing planned: No
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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 Titanium framework reinforced all on four prosthesis and PEEK framework reinforced all on four prosthesis in people with Prosthodontics and Implants, Dental, run by Cairo 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 7 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 Mar 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?
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?
Marginal bone loss (time frame: 12 months at intervals (0,3,6,9and 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07475507, which also lists 1 linked publication.
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 Mar 2026.