All on Four, Marginal Bone Loss, PEEKNCT06591611
Effect of PEEK and Co-Cr Framework Reinforcement on Marginal Bone Loss Around Implants Supporting a Fixed All-on-four Prosthesis in Completely Edentulous Mandibles. A Randomized Controlled Clinial Trial
A study testing PEEK reinforced fixed all-on-four prosthesis in people with All on Four, Marginal Bone Loss, PEEK, run by Cairo University at 1 site in Egypt.
Trial summary
A fixed all-on-four prosthesis will be fabricated for the mandibular 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?
- Any age
- Conditions the study is for
- All on Four, Marginal Bone Loss, PEEK
- What is being tested?
- PEEK reinforced fixed 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 Jan 2024to 30 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Completely edentulous patient with old satisfactory maxillary and mandibular dentures requiring an implant supported restoration
- Implant sites must allow for implant placement
- Patients with no systemic conditions that may interfere with implant placement
Who cannot join
- General contraindications for implant surgery( Poor oral hygiene- diabetes- pregnancy or nursing- drug abusers)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of PEEK and Co-Cr 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 fabricated for the mandibular arch for each patient and the marginal bone loss will be evaluated at baseline, 3,6,9 and 12 months
- Conditions
- All on Four, Marginal Bone Loss, PEEK
- Being tested
- PEEK reinforced fixed all-on-four prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK reinforced fixed all-on-four prosthesisOther
Also called Dental Prosthesis
Fabricating a fixed prosthesis for patients with completely edentulous mandibles reinforced with PEEK
| Study group | Role | What they receive |
|---|---|---|
| Co-Cr reinforced fixed all-on-four prosthesis | Active comparator | Not described Receives: Other: PEEK reinforced fixed all-on-four prosthesis |
| PEEK reinforced fixed all-on-four prosthesis | Experimental | Not described Receives: Other: PEEK reinforced fixed 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 implant
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All on Four, Marginal Bone Loss, PEEKStudies 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, shereen ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591611
- Sponsor's protocol ID
- 21223
- Status last verified
- Sep 2024
- First submitted
- 8 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PEEK and Co-Cr 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
- NCT06591611
- Acronym / sponsor ID
- 21223
- Conditions
- All on Four, Marginal Bone Loss, PEEK
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 19 Sep 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.
A fixed all-on-four prosthesis will be fabricated for the mandibular 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 |
|---|---|---|
| Co-Cr reinforced fixed all-on-four prosthesis | Active comparator | Other: PEEK reinforced fixed all-on-four prosthesis |
| PEEK reinforced fixed all-on-four prosthesis | Experimental | Other: PEEK reinforced fixed all-on-four prosthesis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Completely edentulous patient with old satisfactory maxillary and mandibular dentures requiring an implant supported restoration
- Implant sites must allow for implant placement
- Patients with no systemic conditions that may interfere with implant placement
Key exclusion criteria (1 listed)
- General contraindications for implant surgery( Poor oral hygiene- diabetes- pregnancy or nursing- drug abusers)
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 |
|---|---|---|
| PEEK reinforced fixed all-on-four prosthesisAlso: Dental ProsthesisFabricating a fixed prosthesis for patients with completely edentulous mandibles reinforced with PEEK | Other | Co-Cr reinforced fixed all-on-four prosthesis, PEEK reinforced fixed all-on-four prosthesis |
Primary outcome
Marginal bone loss
Time frame: 12 months
marginal bone loss around each implant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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 PEEK reinforced fixed all-on-four prosthesis in people with All on Four, Marginal Bone Loss, PEEK, 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Sep 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?
Results are not available in the source record.
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). 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 19 Sep 2024.