Patient SatisfactionNCT06111391
Patient Satisfaction , Prosthetic Complications and Clinical Outcomes of PEEK Composite Versus Titanium Zirconium
A study testing Osstell® device (Integration Diagnostics Ltd.). in people with Patient Satisfaction and Prosthetic Complication, run by Mansoura University at 1 site in Egypt.
Trial summary
This study aimed to evaluate patient satisfaction (VAS) , prosthetic outcomes and clinical outcomes of polyether ether ketone (PEEK) Versus Titanium Zirconium fixed prostheses supported by six maxillary implants and opposed by distal extension removable partial denture. Read more about this study
- Who is it for?
- Ages 58 to 68 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Prosthetic Complication, Clinical Outcomes
- What is being tested?
- Osstell® device (Integration Diagnostics Ltd.).
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2022to 2 Apr 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 58 to 68 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal jaw relation Good oral hygiene Patient with class I or class II inter-rach space in order to have sufficient restoration space to construct FP3 prosthesis.
Who cannot join
- Patients with TMJ disorder and heavy smokers for more than 10 cigarettes per day.
- Uncooperative patient. Unfavorable occlusion. Limited restoration space (less than 12 mm).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction , Prosthetic Complication and Clinical Outcomes of PEEK Composite Versus Titanium Zirconium Maxillary Fixed Full Arch Prosthetic Opposing Mandibular Distal Extension Partial Denture
This study aimed to evaluate patient satisfaction (VAS) , prosthetic outcomes and clinical outcomes of polyether ether ketone (PEEK) Versus Titanium Zirconium fixed prostheses supported by six maxillary implants and opposed by distal extension removable partial denture.
Read the detailed description
thirty patients were selected for this study from a previous study who have already received previous implants in the maxillary arch. The patients were divided into two groups: Group1 received maxillary titanium zirconium full arch fixed prosthesis and mandibular distal extension partial denture, Group 2 received maxillary PEEK composite full arch fixed prosthesis and mandibular distal extension partial denture Patient satisfaction was evaluated using visual analogue scale (VAS) after one year months , Prosthetic complications were measured on the patient and implant levels after one year
- Being tested
- Osstell® device (Integration Diagnostics Ltd.).
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osstell® device (Integration Diagnostics Ltd.).Device
After trans-mucosal abutments were removed and the smart pegs were attached to the fixtures, resonance frequency analysis was done to assess implant stability.The implant stability quotient (ISQ) was used to quantify stability via the Osstell® device (Integration Diagnostics Ltd.).
| Study group | Role | What they receive |
|---|---|---|
| maxillary titanium zirconium full arch fixed prosthesis | Active comparator | maxillary titanium zirconium full arch fixed prosthesis and mandibular distal extension partial denture. Receives: Device: Osstell® device (Integration Diagnostics Ltd.). |
| maxillary peek composite full arch fixed prosthesis | Active comparator | maxillary peek composite full arch fixed prosthesis and mandibular distal extension partial denture. Receives: Device: Osstell® device (Integration Diagnostics Ltd.). |
What is being measured
The primary outcome is the main question the study is designed to answer.
implant stability
After transmucosal abutments were removed and the smart pegs were attached to the fixtures, resonance frequency analysis was done to assess implant stability.The implant stability quotient (ISQ) was used to quantify stability via the Osstell® device (Integration Diagnostics Ltd.).
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 posted1 Nov 2023
- Study start15 Apr 2022
- Primary completion12 Mar 2023
- Study completion2 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marwa Aboelez, Phd, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111391
- Sponsor's protocol ID
- A27080622
- Status last verified
- Feb 2022
- First submitted
- 20 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang J, Wu P, Liu HL, Zhang L, Liu LP, Ma CF, Chen JH. Polyetheretherketone versus titanium CAD-CAM framework for implant-supported fixed complete dentures: a retrospective study with up to 5-year follow-up. J Prosthodont Res. 2022 Apr 27;66(2):279-287. doi: 10.2186/jpr.JPR_D_20_00142. Epub 2021 Sep 30.
PubMed 34588401Aboelez MA, Gad RSA, Sapri AMS, Elsyad MA. Clinical and Prosthetic Outcomes of Titanium Zirconium Versus PEEK Composite Maxillary Fixed Prostheses Opposing Distal Extension Partial Dentures: Comparative Clinical Study. J Esthet Restor Dent. 2026 Aug;38(8):1534-1544. doi: 10.1111/jerd.70166. Epub 2026 Apr 20.
PubMed 42010974
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction , Prosthetic Complication and Clinical Outcomes of PEEK Composite Versus Titanium Zirconium Maxillary Fixed Full Arch Prosthetic Opposing Mandibular Distal Extension Partial Denture
- ClinicalTrials.gov ID
- NCT06111391
- Acronym / sponsor ID
- A27080622
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 12 Mar 2023 (actual)
- Study completion
- 2 Apr 2023 (actual)
- First posted
- 1 Nov 2023 (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 study aimed to evaluate patient satisfaction (VAS) , prosthetic outcomes and clinical outcomes of polyether ether ketone (PEEK) Versus Titanium Zirconium fixed prostheses supported by six maxillary implants and opposed by distal extension removable partial denture.
Detailed description
thirty patients were selected for this study from a previous study who have already received previous implants in the maxillary arch. The patients were divided into two groups: Group1 received maxillary titanium zirconium full arch fixed prosthesis and mandibular distal extension partial denture, Group 2 received maxillary PEEK composite full arch fixed prosthesis and mandibular distal extension partial denture Patient satisfaction was evaluated using visual analogue scale (VAS) after one year months , Prosthetic complications were measured on the patient and implant levels after one year
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maxillary titanium zirconium full arch fixed prosthesis | Active comparator | Device: Osstell® device (Integration Diagnostics Ltd.).maxillary titanium zirconium full arch fixed prosthesis and mandibular distal extension partial denture. |
| maxillary peek composite full arch fixed prosthesis | Active comparator | Device: Osstell® device (Integration Diagnostics Ltd.).maxillary peek composite full arch fixed prosthesis and mandibular distal extension partial denture. |
Who may qualify
- Ages
- 58 to 68 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal jaw relation Good oral hygiene Patient with class I or class II inter-rach space in order to have sufficient restoration space to construct FP3 prosthesis.
Key exclusion criteria (2 listed)
- Patients with TMJ disorder and heavy smokers for more than 10 cigarettes per day.
- Uncooperative patient. Unfavorable occlusion. Limited restoration space (less than 12 mm).
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 |
|---|---|---|
| Osstell® device (Integration Diagnostics Ltd.).After trans-mucosal abutments were removed and the smart pegs were attached to the fixtures, resonance frequency analysis was done to assess implant stability.The implant stability quotient (ISQ) was used to quantify stability via the Osstell® device (Integration Diagnostics Ltd.). | Device | maxillary peek composite full arch fixed prosthesis, maxillary titanium zirconium full arch fixed prosthesis |
Primary outcome
implant stability
Time frame: 12 months
After transmucosal abutments were removed and the smart pegs were attached to the fixtures, resonance frequency analysis was done to assess implant stability.The implant stability quotient (ISQ) was used to quantify stability via the Osstell® device (Integration Diagnostics Ltd.).
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 1 Nov 2023.
- Background: PubMed 34588401Wang J, Wu P, Liu HL, Zhang L, Liu LP, Ma CF, Chen JH. Polyetheretherketone versus titanium CAD-CAM framework for implant-supported fixed complete dentures: a retrospective study with up to 5-year follow-up. J Prosthodont Res. 2022 Apr 27;66(2):279-287. doi: 10.2186/jpr.JPR_D_20_00142. Epub 2021 Sep 30.
- Derived from this study: PubMed 42010974Aboelez MA, Gad RSA, Sapri AMS, Elsyad MA. Clinical and Prosthetic Outcomes of Titanium Zirconium Versus PEEK Composite Maxillary Fixed Prostheses Opposing Distal Extension Partial Dentures: Comparative Clinical Study. J Esthet Restor Dent. 2026 Aug;38(8):1534-1544. doi: 10.1111/jerd.70166. Epub 2026 Apr 20.
- 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.
Marwa Aboelez, Phd study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osstell® device (Integration Diagnostics Ltd.). in people with Patient Satisfaction and Prosthetic Complication, 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 1 inclusion and 2 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 1 Nov 2023. 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?
implant stability (time frame: 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 NCT06111391, which also lists 2 linked publications.
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 1 Nov 2023.