Patient SatisfactionNCT05622448
Patient Centered Outcomes and Marginal Bone Changes in CAD/CAM Metallic and (PEEK) Partial Denture Frameworks
A study testing RPD with PEEK framework and RPD with metallic framework in people with Patient Satisfaction, run by Cairo University at 1 site in Egypt.
Trial summary
To compare PEEK to metallic partial denture frameworks in restoring mandibular Kennedy class I regarding patient satisfaction. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- RPD with PEEK framework and RPD with metallic framework
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 30 Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with bilateral free end saddles in the mandible (kennedy class I) with last standing abutment premolar.
- Opposing dentition is fully intact or restored.
- Sufficient inter-arch space.
- Angle's class I maxilla-mandibular relationship.
Who cannot join
- Periodontal affection of the abutment teeth.
- Skeletal mal-relation.
- Unmotivated patients to maintain adequate oral hygiene to follow up.
- Patients with neuromuscular and Psychiatric disorders.
- Systematic disease affecting bone and periodontal health.
- Insufficient inter-arch space.
- Patients with physical reasons that could affect follow up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Centered Outcomes and Marginal Bone Changes in CAD/CAM Metallic and Poly Ether Ether Ketone (PEEK) Partial Denture Frameworks
To compare PEEK to metallic partial denture frameworks in restoring mandibular Kennedy class I regarding patient satisfaction.
Read the detailed description
The traditional RPDs with cobalt chromium frameworks and clasps have been proven to be inexpensive, accurate, durable and resistant to distortion .2 On the other hand, they have; unesthetic display of metallic clasps, increased weight, and may provoke an allergic reaction. Because of those drawbacks new metal-free materials have been reported as a replacement of metal alloys in manufacturing RPDs, including; high performance polymers such as polyethylene glycol, polyetherketonketon (PEKK), polyaryletherketone (PAEK) and Polyetheretherketon (PEEK).
Using PEEK and modified PEEK (BioHPP) frameworks were claimed to reduce the distal torqueing and stresses on the abutments in kennedy class I PPDs which is thought to be beneficial for periodontal health of the abutments.10 One of the factors for the dissatisfaction related to the dentures may be attributed to the level of oral perception of each patient. The satisfaction level of the patient is influenced by several factors, including the dentures quality and the plated area, the quality of interaction in the patient-dentist relationship, past experiences with full dentures, and the psychological personality6. In harmony, such factors may promote the improvement of the mastication, the speech, and the aesthetics of the teeth, besides producing less discomfort and pain sensitivity, favoring the comminution of harder food7. However, there are no clinical trials evaluating the effect of PEEK on patient satisfaction and the marginal bone loss around the abutments.
- Conditions
- Patient Satisfaction
- Being tested
- RPD with PEEK framework, RPD with metallic framework
- Keywords
- peek framework, co-cr framework, removable partial denture
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPD with PEEK frameworkOther
removable partial denture with CAD designed PEEK framework
RPD with metallic frameworkOther
removable partial denture with cobalt chromium framework
| Study group | Role | What they receive |
|---|---|---|
| RPD with metallic framework | Active comparator | removable partial denture with cobalt chromium framework Receives: Other: RPD with PEEK framework; Other: RPD with metallic framework |
| RPD with PEEK framework | Experimental | removable partial denture with poly ether ether ketone framework Receives: Other: RPD with PEEK framework; Other: RPD with metallic framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Patient satisfaction will be measured using a valid and reliable questionnaire which is Patient satisfaction with lower removable denture questionnaire SLRD-Q.
likert scale ranges from very good (1) to good (2), neither good nor bad (3), bad (4), and extremely bad (5)
Measured: From enrollment to the last follow up
Oral Health Related quality of life
Measured: From enrollment to the last follow up
Secondary outcomes (1)
Marginal bone changes.
Radiographic follow up will be performed for marginal bone changes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Oct 2019
- Primary completion1 Jun 2022
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa Sedky Abd El-lateef, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622448
- Sponsor's protocol ID
- patient satisfaction and RPD
- Status last verified
- Nov 2022
- First submitted
- 18 Jul 2019
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Outcomes and Marginal Bone Changes in CAD/CAM Metallic and Poly Ether Ether Ketone (PEEK) Partial Denture Frameworks
- ClinicalTrials.gov ID
- NCT05622448
- Acronym / sponsor ID
- patient satisfaction and RPD
- Conditions
- Patient Satisfaction
- Keywords
- peek framework, co-cr framework, removable partial denture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 18 Nov 2022 (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.
To compare PEEK to metallic partial denture frameworks in restoring mandibular Kennedy class I regarding patient satisfaction.
Detailed description
The traditional RPDs with cobalt chromium frameworks and clasps have been proven to be inexpensive, accurate, durable and resistant to distortion .2 On the other hand, they have; unesthetic display of metallic clasps, increased weight, and may provoke an allergic reaction. Because of those drawbacks new metal-free materials have been reported as a replacement of metal alloys in manufacturing RPDs, including; high performance polymers such as polyethylene glycol, polyetherketonketon (PEKK), polyaryletherketone (PAEK) and Polyetheretherketon (PEEK).
Using PEEK and modified PEEK (BioHPP) frameworks were claimed to reduce the distal torqueing and stresses on the abutments in kennedy class I PPDs which is thought to be beneficial for periodontal health of the abutments.10 One of the factors for the dissatisfaction related to the dentures may be attributed to the level of oral perception of each patient. The satisfaction level of the patient is influenced by several factors, including the dentures quality and the plated area, the quality of interaction in the patient-dentist relationship, past experiences with full dentures, and the psychological personality6. In harmony, such factors may promote the improvement of the mastication, the speech, and the aesthetics of the teeth, besides producing less discomfort and pain sensitivity, favoring the comminution of harder food7. However, there are no clinical trials evaluating the effect of PEEK on patient satisfaction and the marginal bone loss around the abutments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPD with metallic framework | Active comparator | Other: RPD with PEEK framework, Other: RPD with metallic frameworkremovable partial denture with cobalt chromium framework |
| RPD with PEEK framework | Experimental | Other: RPD with PEEK framework, Other: RPD with metallic frameworkremovable partial denture with poly ether ether ketone framework |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with bilateral free end saddles in the mandible (kennedy class I) with last standing abutment premolar.
- Opposing dentition is fully intact or restored.
- Sufficient inter-arch space.
- Angle's class I maxilla-mandibular relationship.
Key exclusion criteria (7 listed)
- Periodontal affection of the abutment teeth.
- Skeletal mal-relation.
- Unmotivated patients to maintain adequate oral hygiene to follow up.
- Patients with neuromuscular and Psychiatric disorders.
- Systematic disease affecting bone and periodontal health.
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 |
|---|---|---|
| RPD with PEEK frameworkremovable partial denture with CAD designed PEEK framework | Other | RPD with PEEK framework, RPD with metallic framework |
| RPD with metallic frameworkremovable partial denture with cobalt chromium framework | Other | RPD with PEEK framework, RPD with metallic framework |
Primary outcome
patient satisfaction
Time frame: From enrollment to the last follow up
Patient satisfaction will be measured using a valid and reliable questionnaire which is Patient satisfaction with lower removable denture questionnaire SLRD-Q. likert scale ranges from very good (1) to good (2), neither good nor bad (3), bad (4), and extremely bad (5)
Oral Health Related quality of life
Time frame: From enrollment to the last follow up
1 secondary outcome
Marginal bone changes.
Time frame: 2 years
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 5 Feb 2025.
- 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 RPD with PEEK framework and RPD with metallic framework in people with Patient Satisfaction, 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 4 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: finished, as of the sponsor's last update on 5 Feb 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: From enrollment to the last follow up). 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 5 Feb 2025.