RetentionNCT05670899
Retention of CAD Metallic and Poly Ether Ether Ketone (PEEK) Frameworks
A study testing CAD PEEK frame-work in people with Retention, run by Cairo University at 1 site in Egypt.
Trial summary
comparing retention of CAD CAM metallic and Poly Ether Ether Ketone (PEEK) partial dentures in Kennedy class I casses Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Retention
- What is being tested?
- CAD PEEK frame-work
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 20 Aug 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- 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.
- 2- Opposing dentition is fully intact or restored. 3- Sufficient inter-arch space. 4- 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: Retention of CAD Metallic and Poly Ether Ether Ketone (PEEK) Frameworks in Mandibular Kennedy Class I Cases: a Randomized Clinical Trial
comparing retention of CAD CAM metallic and Poly Ether Ether Ketone (PEEK) partial dentures in Kennedy class I casses
Read the detailed description
partially edentulous patients with Kennedy class I classification will be recruited for the trial and then randomly distributed on two groups; experimental group will receive CAD CAM PEEK partial denture and control group will receive CAD CAM metallic partial denture. then primary impressions will be made and then mouth preparation followed by secondary impression then scanning of the master cast using extra-oral scanner then designing the partial denture using blender for dental then the frame work will be printed.
then frame work will be processed into either PEEK or Metal according to randomization.
retention will be measured at zero and 3 months.
- Conditions
- Retention
- Being tested
- CAD PEEK frame-work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAD PEEK frame-workProcedure or surgery
Construction of PEEK framework will be done conventionally by lost wax technique using a vacuum press device. The wax pattern will be invested in a mold using special investment. Then it will be heated and melted to produce a mold into which PEEK will be vacuum pressed. The framework will be fitted on the master cast
| Study group | Role | What they receive |
|---|---|---|
| CAD PEEK frame-work | Experimental | Construction of PEEK framework will be done conventionally by lost wax technique using a vacuum press device. The wax pattern will be invested in a mold using special investment. Then it will be heated and melted to produce a mold into which PEEK will be vacuum pressed. The framework will be fitted on the master cast Receives: Procedure: CAD PEEK frame-work |
| CAD metallic frame-work | Active comparator | A metallic framework will be obtained using the conventional lost wax technique and casting. After de-investing, finishing and polishing, the framework will be fitted on the master cast. Intraoral try in of the framework will be done followed by bite registration record. The next step will be teeth setting and try in. Heat cured acrylic resin denture base will be processed, finished and polished conventionally. The finished removable partial denture will then be checked intraorally for any needed modifications and finally delivered. Receives: Procedure: CAD PEEK frame-work |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention
Measurements are performed for each RPD at the time of denture insertion, after one month and three months later. Measurements were carried out using digital force gauge which is an advanced type of force meter device, used to measure tension or compression up to 20 Kg
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start20 Mar 2023 (estimated)
- Primary completion20 Apr 2023 (estimated)
- Study completion20 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RetentionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Magdy Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670899
- Sponsor's protocol ID
- 91122
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 4 Jan 2023
- 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention of CAD Metallic and Poly Ether Ether Ketone (PEEK) Frameworks in Mandibular Kennedy Class I Cases: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05670899
- Acronym / sponsor ID
- 91122
- Conditions
- Retention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (estimated)
- Primary completion
- 20 Apr 2023 (estimated)
- Study completion
- 20 Aug 2023 (estimated)
- First posted
- 4 Jan 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.
comparing retention of CAD CAM metallic and Poly Ether Ether Ketone (PEEK) partial dentures in Kennedy class I casses
Detailed description
partially edentulous patients with Kennedy class I classification will be recruited for the trial and then randomly distributed on two groups; experimental group will receive CAD CAM PEEK partial denture and control group will receive CAD CAM metallic partial denture. then primary impressions will be made and then mouth preparation followed by secondary impression then scanning of the master cast using extra-oral scanner then designing the partial denture using blender for dental then the frame work will be printed.
then frame work will be processed into either PEEK or Metal according to randomization.
retention will be measured at zero and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD PEEK frame-work | Experimental | Procedure: CAD PEEK frame-workConstruction of PEEK framework will be done conventionally by lost wax technique using a vacuum press device. The wax pattern will be invested in a mold using special investment. Then it will be heated and melted to produce a mold into which PEEK will be vacuum pressed. The framework will be fitted on the master cast |
| CAD metallic frame-work | Active comparator | Procedure: CAD PEEK frame-workA metallic framework will be obtained using the conventional lost wax technique and casting. After de-investing, finishing and polishing, the framework will be fitted on the master cast. Intraoral try in of the framework will be done followed by bite registration record. The next step will be teeth setting and try in. Heat cured acrylic resin denture base will be processed, finished and polished conventionally. The finished removable partial denture will then be checked intraorally for any needed modifications and finally delivered. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with bilateral free end saddles in the mandible (kennedy class I) with last standing abutment premolar.
- 2- Opposing dentition is fully intact or restored. 3- Sufficient inter-arch space. 4- 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 |
|---|---|---|
| CAD PEEK frame-workConstruction of PEEK framework will be done conventionally by lost wax technique using a vacuum press device. The wax pattern will be invested in a mold using special investment. Then it will be heated and melted to produce a mold into which PEEK will be vacuum pressed. The framework will be fitted on the master cast | Procedure or surgery | CAD PEEK frame-work, CAD metallic frame-work |
Primary outcome
retention
Time frame: 3 months
Measurements are performed for each RPD at the time of denture insertion, after one month and three months later. Measurements were carried out using digital force gauge which is an advanced type of force meter device, used to measure tension or compression up to 20 Kg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
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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 CAD PEEK frame-work in people with Retention, 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 2 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 4 Jan 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?
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?
retention (time frame: 3 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 4 Jan 2023.