Satisfaction, PatientNCT06700733
PEEK Vs Titanium for All-on-4 Prosthesis
A study testing PEEK prosthesis and Titanium prosthesis in people with Satisfaction, Patient and Bite Force, run by Mansoura University at 1 site in Egypt.
Trial summary
This crossover clinical study will examine the impact of the framework material of implant-supported prostheses on patient satisfaction and Oral Health-Related Quality of Life (OHRQoL) with mandibular All-on-4 implant distribution. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Satisfaction, Patient, Bite Force
- What is being tested?
- PEEK prosthesis and Titanium prosthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Feb 2022to 12 Mar 2023
- 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 40 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria include
- healthy male patients free from systemic diseases that may affect bone health, such as uncontrolled diabetes mellitus and osteoporosis.
- implants placed with the All-on-4 concept in the mandible.
Who cannot join
- The exclusion criteria: the patients with a history of parafunctional habits (bruxism and clenching), smoking, and alcoholism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Polyetheretherketone (PEEK) Versus Titanium Frameworks for All-on-4 Implant Full-arch Prosthesis: Within-patient Evaluation of Patient Satisfaction, Oral Health-related Quality of Life (OHRQoL), Chewing Efficiency and Maximum Bite Force
This crossover clinical study will examine the impact of the framework material of implant-supported prostheses on patient satisfaction and Oral Health-Related Quality of Life (OHRQoL) with mandibular All-on-4 implant distribution. The trial will investigate subject satisfaction, OHRQoL as the primary outcome, and chewing efficiency and maximum bite force as secondary outcomes for different framework materials used in implant-supported screw-retained restorations. The first null hypothesis states no significant difference in patient satisfaction and OHRQoL between the tested prostheses. Additionally, the second null hypothesis states no significant difference in chewing efficiency and maximum bite force between the tested prostheses.
Read the detailed description
Prosthetic steps
- For each patient, an abutment-level impression will be made, and the resultant cast will be 3D scanned for CAD/CAM construction of a PEEK superstructure with abutments.
- A verification jig will be constructed to ensure the accuracy of the cast.
- The final prosthesis will be virtually planned by using the Exo-Cad software.
- The final prosthesis will be milled in Duralay polymerized resin disk, and the prosthesis resin pattern will be tried intra-orally for passive fit using a screw test.
- For the PP, The PEEK framework will be constructed, the fit of the PEEK framework will be verified intraorally, and the final screw-retained prosthesis will be constructed of PMMA teeth and a visiolign pink composite estimating the gingival tissue.
- For the TP, the framework will be milled from Ti blocks according to the virtual design of the final prosthesis framework. PMMA teeth then will be cemented, and the final prosthesis will be screwed.
Evaluation
- Patient satisfaction (VAS) Patient satisfaction will be evaluated using a questionnaire based on a visual analog scale (VAS).(21) Patients will be asked to mark their answer (amount of satisfaction) on a 100-mm line (with zero referring to not satisfied at all and 100 referring to completely satisfied). The mean of the answers (length of the lines from zero to the marks in mm) for each question was subjected to statistical analysis.
- Oral health-related quality of life (OHIP-14) The oral health impact profile (OHIP-14) questionnaire was used to measure OHRQoL. The full OHIP questionnaire consisted of 49 items covering seven main domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, and social disability. The OHIP-14 questionnaires were translated into Arabic by linguistic professionals who worked in collaboration with the authors to prepare the final version.
- Evaluation of masticatory efficiency: Chewing efficiency will be evaluated using the color mixing ability test.
- Evaluation of maximum bite force (BF): A digital BF transducer will be used to evaluate maximum BF in Newton (N).
- Conditions
- Satisfaction, Patient, Bite Force
- Being tested
- PEEK prosthesis, Titanium prosthesis
- Keywords
- PEEK, Titanium, All-on-4
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK prosthesisDevice
Also called Titanium prosthesis
For the PP, The PEEK framework will be constructed, the fit of the PEEK framework will be verified intraorally, and the final screw-retained prosthesis will be constructed of PMMA teeth and a visiolign pink composite estimating the gingival tissue.
Titanium prosthesisDevice
For the TP, the framework will be milled from Ti blocks according to the virtual design of the final prosthesis framework. PMMA teeth then will be cemented, and the final prosthesis will be screwed.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | The first 9 patients will receive the PEEK prosthesis (PP) first. After 3 months, chewing efficiency, maximum bite force, patient satisfaction, and OHRQoL will be measured, and PP will be replaced by a Titanium prosthesis (TP). After another 3 months, the measurements will be repeated. Receives: Device: PEEK prosthesis; Device: Titanium prosthesis |
| study group 1 | Experimental | The second 9 patients will receive TP first, and after 3 months, measurements will be made. Then, TP was replaced by PP, and measurements will be repeated after another 3 months. This randomization will be made to reduce the effect of prosthesis type and bias Receives: Device: PEEK prosthesis; Device: Titanium prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Patient satisfaction will be evaluated using a questionnaire based on a visual analog scale
Measured: 3 month
chewing efficiency
Chewing efficiency will be evaluated using the color mixing ability test
Measured: 3 month
Secondary outcomes (2)
Oral health-related quality of life (OHRQoL)
The oral health impact profile (OHIP-14) questionnaire was used to measure OHRQoL.
Measured: 3 month
maximum bite force (BF)
A digital BF transducer will be used to evaluate maximum BF in Newton (N)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start23 Feb 2022
- Primary completion1 Mar 2023
- Study completion12 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satisfaction, PatientStudies 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
- Crossover
- Model description
- All selected patients will receive maxillary complete dentures and mandibular screw-retained prosthesis either from PEEK or Titanium framework in a crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khloud Ezzat, Mansoura University
- Investigators
- Khloud Ezzat, PhD, Principal investigator, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700733
- Sponsor's protocol ID
- A0508024RP
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyetheretherketone (PEEK) Versus Titanium Frameworks for All-on-4 Implant Full-arch Prosthesis: Within-patient Evaluation of Patient Satisfaction, Oral Health-related Quality of Life (OHRQoL), Chewing Efficiency and Maximum Bite Force
- ClinicalTrials.gov ID
- NCT06700733
- Acronym / sponsor ID
- A0508024RP
- Conditions
- Satisfaction, Patient, Bite Force
- Keywords
- PEEK, Titanium, All-on-4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 22 Nov 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.
This crossover clinical study will examine the impact of the framework material of implant-supported prostheses on patient satisfaction and Oral Health-Related Quality of Life (OHRQoL) with mandibular All-on-4 implant distribution. The trial will investigate subject satisfaction, OHRQoL as the primary outcome, and chewing efficiency and maximum bite force as secondary outcomes for different framework materials used in implant-supported screw-retained restorations. The first null hypothesis states no significant difference in patient satisfaction and OHRQoL between the tested prostheses. Additionally, the second null hypothesis states no significant difference in chewing efficiency and maximum bite force between the tested prostheses.
Detailed description
Prosthetic steps
- For each patient, an abutment-level impression will be made, and the resultant cast will be 3D scanned for CAD/CAM construction of a PEEK superstructure with abutments.
- A verification jig will be constructed to ensure the accuracy of the cast.
- The final prosthesis will be virtually planned by using the Exo-Cad software.
- The final prosthesis will be milled in Duralay polymerized resin disk, and the prosthesis resin pattern will be tried intra-orally for passive fit using a screw test.
- For the PP, The PEEK framework will be constructed, the fit of the PEEK framework will be verified intraorally, and the final screw-retained prosthesis will be constructed of PMMA teeth and a visiolign pink composite estimating the gingival tissue.
- For the TP, the framework will be milled from Ti blocks according to the virtual design of the final prosthesis framework. PMMA teeth then will be cemented, and the final prosthesis will be screwed.
Evaluation
- Patient satisfaction (VAS) Patient satisfaction will be evaluated using a questionnaire based on a visual analog scale (VAS).(21) Patients will be asked to mark their answer (amount of satisfaction) on a 100-mm line (with zero referring to not satisfied at all and 100 referring to completely satisfied). The mean of the answers (length of the lines from zero to the marks in mm) for each question was subjected to statistical analysis.
- Oral health-related quality of life (OHIP-14) The oral health impact profile (OHIP-14) questionnaire was used to measure OHRQoL. The full OHIP questionnaire consisted of 49 items covering seven main domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, and social disability. The OHIP-14 questionnaires were translated into Arabic by linguistic professionals who worked in collaboration with the authors to prepare the final version.
- Evaluation of masticatory efficiency: Chewing efficiency will be evaluated using the color mixing ability test.
- Evaluation of maximum bite force (BF): A digital BF transducer will be used to evaluate maximum BF in Newton (N).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All selected patients will receive maxillary complete dentures and mandibular screw-retained prosthesis either from PEEK or Titanium framework in a crossover design.
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: PEEK prosthesis, Device: Titanium prosthesisThe first 9 patients will receive the PEEK prosthesis (PP) first. After 3 months, chewing efficiency, maximum bite force, patient satisfaction, and OHRQoL will be measured, and PP will be replaced by a Titanium prosthesis (TP). After another 3 months, the measurements will be repeated. |
| study group 1 | Experimental | Device: PEEK prosthesis, Device: Titanium prosthesisThe second 9 patients will receive TP first, and after 3 months, measurements will be made. Then, TP was replaced by PP, and measurements will be repeated after another 3 months. This randomization will be made to reduce the effect of prosthesis type and bias |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The inclusion criteria include
- healthy male patients free from systemic diseases that may affect bone health, such as uncontrolled diabetes mellitus and osteoporosis.
- implants placed with the All-on-4 concept in the mandible.
Key exclusion criteria (1 listed)
- The exclusion criteria: the patients with a history of parafunctional habits (bruxism and clenching), smoking, and alcoholism
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 prosthesisAlso: Titanium prosthesisFor the PP, The PEEK framework will be constructed, the fit of the PEEK framework will be verified intraorally, and the final screw-retained prosthesis will be constructed of PMMA teeth and a visiolign pink composite estimating the gingival tissue. | Device | study group, study group 1 |
| Titanium prosthesisFor the TP, the framework will be milled from Ti blocks according to the virtual design of the final prosthesis framework. PMMA teeth then will be cemented, and the final prosthesis will be screwed. | Device | study group, study group 1 |
Primary outcome
patient satisfaction
Time frame: 3 month
Patient satisfaction will be evaluated using a questionnaire based on a visual analog scale
chewing efficiency
Time frame: 3 month
Chewing efficiency will be evaluated using the color mixing ability test
2 secondary outcomes
Oral health-related quality of life (OHRQoL)
Time frame: 3 month
maximum bite force (BF)
Time frame: 3 month
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 Jan 2025.
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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.
Khloud Ezzat, PhD principal investigator
Lecturer
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 prosthesis and Titanium prosthesis in people with Satisfaction, Patient and Bite Force, run by Mansoura 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: finished, as of the sponsor's last update on 7 Jan 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?
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?
patient satisfaction (time frame: 3 month). The study lists 2 primary outcomes in all. 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 Jan 2025; AzTrials last refreshed its copy on 28 Oct 2026.