Complete EdentulismNCT06631573
Prosthetic Complications in Fixed All-On-Four Prosthesis Reinforced with Poly Ether Ether Ketone (PEEK) Versus Cobalt Chromium (Co-Cr) Framework
A study testing fixed all-on-four prosthesis reinforced with PEEK framework. and Fixed all-on-four prosthesis reinforced with Co-Cr framework in people with Complete Edentulism, run by Cairo University at 1 site in Egypt.
Trial summary
Prosthetic complication will be measured for all-on-four fixed prosthesis in the mandibular arch in completely edentulous patients. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Complete Edentulism
- What is being tested?
- fixed all-on-four prosthesis reinforced with PEEK framework. and Fixed all-on-four prosthesis reinforced with Co-Cr framework
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2024to 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration.
- Patients aged from 50 to 70, 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-extractive sites, they must have been healed for at least 3-month 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.
- Pregnancy or nursing.
- Drug abusers.
- Psychiatric problems or unrealistic expectations.
- Patients with infection and or inflammation in the area intended for implant placement.
- Patients participating in other studies, if the present protocol cannot be properly adhered to.
- Patients with signs of hyperactive muscles.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prosthetic Complications in Fixed All-On-Four Prosthesis Reinforced with Poly Ether Ether Ketone (PEEK) Versus Cobalt Chromium (Co-Cr) Framework in Completely Edentulous Mandibular Arches. (Randomized Controlled Clinical Trial)
Prosthetic complication will be measured for all-on-four fixed prosthesis in the mandibular arch in completely edentulous patients.
Read the detailed description
Four implants will be placed in the edentulous mandible following all on four surgical protocol. After 3 months as a healing phase, a definitive prosthesis will be fabricated after ensuring the complete osseointegration of all implants. Provisional restorations will be removed, and final impressions will be taken for each patient using addition silicon impression materials. Framework will be constructed using either Cobalt Chromium (Co-Cr) or Poly Ether Ether Ketone (PEEK) according to the randomization process. Jaw relation and try-in will be done to ensure the correct centric relation. Final prosthesis is then screwed to the abutments and the screw hole channels are closed with composite resin restorations. Occlusal adjustments will be done after the delivery and in the subsequent follow up visit. Prosthetic complications (primary outcome) and biological considerations (secondary outcome) will be measured every 3 months along the follow up period which is one year.
- Conditions
- Complete Edentulism
- Being tested
- fixed all-on-four prosthesis reinforced with PEEK framework., Fixed all-on-four prosthesis reinforced with Co-Cr framework
- Keywords
- all on four , PEEK, Co-Cr, Cobalt Chromium, hybrid prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixed all-on-four prosthesis reinforced with PEEK framework.Other
Prosthetic rehabilitation of mandibular edentulous arches with fixed all-on-four prosthesis reinforced with PEEK framework.
Fixed all-on-four prosthesis reinforced with Co-Cr frameworkOther
Prosthetic rehabilitation of mandibular edentulous arches with fixed all-on-four prosthesis reinforced with Co-Cr framework
| Study group | Role | What they receive |
|---|---|---|
| Fixed all-on-four prosthesis reinforced with PEEK framework. | Experimental | Not described Receives: Other: fixed all-on-four prosthesis reinforced with PEEK framework. |
| Fixed all-on-four prosthesis reinforced with Co-Cr framework | Active comparator | Not described Receives: Other: Fixed all-on-four prosthesis reinforced with Co-Cr framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic complications
record any prosthetic problem that occurs during the follow up period (such as screw loosening, screw fracture, prosthesis fracture, ....etc.)
Measured: one year
Secondary outcomes (1)
Biological considerations
measure any biological problem in soft tissue around the implants (bleeding on probing, suppuration, .... etc.)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start18 Jan 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complete EdentulismStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohannad Alaa Eldin Samy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631573
- Sponsor's protocol ID
- 11223
- Status last verified
- Dec 2023
- First submitted
- 16 Sep 2024
- Last updated
- 8 Oct 2024
- 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 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Complications in Fixed All-On-Four Prosthesis Reinforced with Poly Ether Ether Ketone (PEEK) Versus Cobalt Chromium (Co-Cr) Framework in Completely Edentulous Mandibular Arches. (Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06631573
- Acronym / sponsor ID
- 11223
- Conditions
- Complete Edentulism
- Keywords
- all on four , PEEK, Co-Cr, Cobalt Chromium, hybrid prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 8 Oct 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.
Prosthetic complication will be measured for all-on-four fixed prosthesis in the mandibular arch in completely edentulous patients.
Detailed description
Four implants will be placed in the edentulous mandible following all on four surgical protocol. After 3 months as a healing phase, a definitive prosthesis will be fabricated after ensuring the complete osseointegration of all implants. Provisional restorations will be removed, and final impressions will be taken for each patient using addition silicon impression materials. Framework will be constructed using either Cobalt Chromium (Co-Cr) or Poly Ether Ether Ketone (PEEK) according to the randomization process. Jaw relation and try-in will be done to ensure the correct centric relation. Final prosthesis is then screwed to the abutments and the screw hole channels are closed with composite resin restorations. Occlusal adjustments will be done after the delivery and in the subsequent follow up visit. Prosthetic complications (primary outcome) and biological considerations (secondary outcome) will be measured every 3 months along the follow up period which is one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed all-on-four prosthesis reinforced with PEEK framework. | Experimental | Other: fixed all-on-four prosthesis reinforced with PEEK framework. |
| Fixed all-on-four prosthesis reinforced with Co-Cr framework | Active comparator | Other: Fixed all-on-four prosthesis reinforced with Co-Cr framework |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Any completely edentulous patient (mandible) with an old satisfactory denture requiring an implant-supported restoration.
- Patients aged from 50 to 70, 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-extractive sites, they must have been healed for at least 3-month before being treated in the study.
Key exclusion criteria (7 listed)
- Patients with poor oral hygiene and motivation.
- Pregnancy or nursing.
- Drug abusers.
- Psychiatric problems or unrealistic expectations.
- Patients with infection and or inflammation in the area intended for 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 |
|---|---|---|
| fixed all-on-four prosthesis reinforced with PEEK framework.Prosthetic rehabilitation of mandibular edentulous arches with fixed all-on-four prosthesis reinforced with PEEK framework. | Other | Fixed all-on-four prosthesis reinforced with PEEK framework. |
| Fixed all-on-four prosthesis reinforced with Co-Cr frameworkProsthetic rehabilitation of mandibular edentulous arches with fixed all-on-four prosthesis reinforced with Co-Cr framework | Other | Fixed all-on-four prosthesis reinforced with Co-Cr framework |
Primary outcome
Prosthetic complications
Time frame: one year
record any prosthetic problem that occurs during the follow up period (such as screw loosening, screw fracture, prosthesis fracture, ....etc.)
1 secondary outcome
Biological considerations
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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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 fixed all-on-four prosthesis reinforced with PEEK framework. and Fixed all-on-four prosthesis reinforced with Co-Cr framework in people with Complete Edentulism, 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 6 inclusion and 7 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 8 Oct 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?
Prosthetic complications (time frame: one year). 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 8 Oct 2024.