Partial EdentulismPEEKWearNCT07708558
Surface Wear of PEEK Clasp Against Zirconia Full-Coverage Restored Abutments in Distal Extension Removable Partial Dentures
A study testing PEEK Removable Partial Denture Framework with Natural Tooth Abutments and PEEK Removable Partial Denture Framework with Zirconia Abutments in people with Partial Edentulism and Partial Edentulism Class 1, run by Mansoura University at 1 site in Egypt.
Trial summary
This prospective clinical comparative study will evaluate the surface wear of BioHPP (modified polyetheretherketone) clasps opposing either natural tooth abutments or zirconia full-coverage abutments in mandibular bilateral distal extension removable partial dentures. Read more about this study
- Who is it for?
- Ages 40 to 50 years
- Conditions the study is for
- Partial Edentulism, Partial Edentulism Class 1
- What is being tested?
- PEEK Removable Partial Denture Framework with Natural Tooth Abutments and PEEK Removable Partial Denture Framework with Zirconia Abutments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 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 40 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 40-50 years. Mandibular Kennedy Class I partial edentulism. Bilateral distal extension edentulous areas. Presence of healthy canines and first premolars suitable as abutment teeth. Adequate oral hygiene and healthy periodontal condition. Adequate interarch space for removable partial denture fabrication. Ability and willingness to attend all scheduled follow-up visits and provide written informed consent.
Who cannot join
- Systemic diseases or medications that could affect bone or soft tissue healing. Active periodontal disease or poor oral hygiene. Severe parafunctional habits (e.g., bruxism or clenching). Smoking. Pregnancy or lactation. Allergy or hypersensitivity to any study materials. Inability to comply with study procedures or follow-up visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of Surface Wear of PEEK Clasps Against Zirconia Full-Coverage Restored Abutments in Distal Extension Removable Partial Dentures
This prospective clinical comparative study will evaluate the surface wear of BioHPP (modified polyetheretherketone) clasps opposing either natural tooth abutments or zirconia full-coverage abutments in mandibular bilateral distal extension removable partial dentures. Ten participants will be randomly assigned to two equal groups. Surface topography changes of the clasp fitting surfaces will be assessed using scanning electron microscopy (SEM) at denture insertion, 6 months, and 12 months. The findings will help determine the influence of abutment material on the wear behavior of BioHPP clasps and provide evidence for selecting appropriate abutment materials in removable partial denture treatment.
- Conditions
- Partial Edentulism, Partial Edentulism Class 1
- Being tested
- PEEK Removable Partial Denture Framework with Natural Tooth Abutments, PEEK Removable Partial Denture Framework with Zirconia Abutments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK Removable Partial Denture Framework with Natural Tooth AbutmentsDevice
BioHPP Removable Partial Denture Framework with Natural Tooth Abutments
PEEK Removable Partial Denture Framework with Zirconia AbutmentsDevice
BioHPP Removable Partial Denture Framework with Zirconia Abutments
| Study group | Role | What they receive |
|---|---|---|
| BioHPP Clasps Opposing Natural Tooth Abutments | Experimental | Participants receive mandibular bilateral distal extension removable partial dentures with BioHPP clasps engaging natural tooth abutments. The surface topography of the clasp fitting surfaces will be evaluated using scanning electron microscopy (SEM) at denture insertion, 6 months, and 12 months to assess surface wear. Receives: Device: PEEK Removable Partial Denture Framework with Natural Tooth Abutments |
| BioHPP Clasps Opposing Zirconia Abutmen | Experimental | Participants receive mandibular bilateral distal extension removable partial dentures with BioHPP clasps engaging zirconia full-coverage abutments. The surface topography of the clasp fitting surfaces will be evaluated using scanning electron microscopy (SEM) at denture insertion, 6 months, and 12 months to assess surface wear. Receives: Device: PEEK Removable Partial Denture Framework with Zirconia Abutments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface topography changes of BioHPP clasp fitting surfaces
Surface wear of BioHPP clasp fitting surfaces assessed by scanning electron microscopy (SEM) and digital morphometric analysis
Measured: Baseline (denture insertion), 6 months, and 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 Jul 2026
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial EdentulismStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708558
- Sponsor's protocol ID
- PROS-PEEK-2025-01
- Acronym
- PEEKWear
- Status last verified
- Jun 2023
- First submitted
- 13 Jul 2026
- Last updated
- 16 Jul 2026
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Surface Wear of PEEK Clasps Against Zirconia Full-Coverage Restored Abutments in Distal Extension Removable Partial Dentures
- ClinicalTrials.gov ID
- NCT07708558
- Acronym / sponsor ID
- PEEKWear / PROS-PEEK-2025-01
- Conditions
- Partial Edentulism, Partial Edentulism Class 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 16 Jul 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.
This prospective clinical comparative study will evaluate the surface wear of BioHPP (modified polyetheretherketone) clasps opposing either natural tooth abutments or zirconia full-coverage abutments in mandibular bilateral distal extension removable partial dentures. Ten participants will be randomly assigned to two equal groups. Surface topography changes of the clasp fitting surfaces will be assessed using scanning electron microscopy (SEM) at denture insertion, 6 months, and 12 months. The findings will help determine the influence of abutment material on the wear behavior of BioHPP clasps and provide evidence for selecting appropriate abutment materials in removable partial denture treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BioHPP Clasps Opposing Natural Tooth Abutments | Experimental | Device: PEEK Removable Partial Denture Framework with Natural Tooth AbutmentsParticipants receive mandibular bilateral distal extension removable partial dentures with BioHPP clasps engaging natural tooth abutments. The surface topography of the clasp fitting surfaces will be evaluated using scanning electron microscopy (SEM) at denture insertion, 6 months, and 12 months to assess surface wear. |
| BioHPP Clasps Opposing Zirconia Abutmen | Experimental | Device: PEEK Removable Partial Denture Framework with Zirconia AbutmentsParticipants receive mandibular bilateral distal extension removable partial dentures with BioHPP clasps engaging zirconia full-coverage abutments. The surface topography of the clasp fitting surfaces will be evaluated using scanning electron microscopy (SEM) at denture insertion, 6 months, and 12 months to assess surface wear. |
Who may qualify
- Ages
- 40 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults aged 40-50 years. Mandibular Kennedy Class I partial edentulism. Bilateral distal extension edentulous areas. Presence of healthy canines and first premolars suitable as abutment teeth. Adequate oral hygiene and healthy periodontal condition. Adequate interarch space for removable partial denture fabrication. Ability and willingness to attend all scheduled follow-up visits and provide written informed consent.
Key exclusion criteria (1 listed)
- Systemic diseases or medications that could affect bone or soft tissue healing. Active periodontal disease or poor oral hygiene. Severe parafunctional habits (e.g., bruxism or clenching). Smoking. Pregnancy or lactation. Allergy or hypersensitivity to any study materials. Inability to comply with study procedures or follow-up visits.
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 Removable Partial Denture Framework with Natural Tooth AbutmentsBioHPP Removable Partial Denture Framework with Natural Tooth Abutments | Device | BioHPP Clasps Opposing Natural Tooth Abutments |
| PEEK Removable Partial Denture Framework with Zirconia AbutmentsBioHPP Removable Partial Denture Framework with Zirconia Abutments | Device | BioHPP Clasps Opposing Zirconia Abutmen |
Primary outcome
Surface topography changes of BioHPP clasp fitting surfaces
Time frame: Baseline (denture insertion), 6 months, and 12 months
Surface wear of BioHPP clasp fitting surfaces assessed by scanning electron microscopy (SEM) and digital morphometric analysis
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 16 Jul 2026.
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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 Removable Partial Denture Framework with Natural Tooth Abutments and PEEK Removable Partial Denture Framework with Zirconia Abutments in people with Partial Edentulism and Partial Edentulism Class 1, 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 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 16 Jul 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?
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?
Surface topography changes of BioHPP clasp fitting surfaces (time frame: Baseline (denture insertion), 6 months, and 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 16 Jul 2026.