Partial EdentulismNCT06789627
Oral Health Related Quality of Life in Cad Metallic and Poly Ether Ether Ketone (Peek) Partial Denture Frameworks in Mandibular Kennedy Class I Cases
A study testing RPD with PEEK framework and RPD with metallic framework in people with Partial Edentulism and Oral Health-Related Quality of Life, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study was to compare CAD Poly ether ether ketone (PEEK) RPD to CAD metallic RPD in treating partial edentulism in terms of Oral health related quality of life Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Partial Edentulism, Oral Health-Related Quality of Life
- 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
- 10 Oct 2021to 1 Apr 2024
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with bilateral free end saddles in the mandible (Kennedy class I) with the last standing abutment second premolar
- Opposing dentition is fully intact or restored to be intact
- Adequate inter-arch space of at least 7mm
- Angle's class I maxilla-mandibular relationship
- Patients with no periodontal disease and good oral hygiene
- Cooperative patients showing motivation to follow-up
Who cannot join
- Periodontal affection of the abutment teeth
- Skeletal mal-relationship
- Unmotivated patients to maintain adequate oral hygiene and to follow up---- ---- Patients with neuro-mascular disorders
- Systemic disease affecting periodontal health like uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Indirect CAD/CAM Removable Partial Denture Frameworks: a Comparative Study
The aim of this study was to compare CAD Poly ether ether ketone (PEEK) RPD to CAD metallic RPD in treating partial edentulism in terms of Oral health related quality of life
- Being tested
- RPD with PEEK framework, RPD with metallic framework
- Keywords
- CAD/CAM, Digital metallic RPD, patient centered outcomes, 3D printing, PEEK, OHIP-14
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPD with PEEK frameworkOther
Indirectly CAD/CAM produced PEEK framework
RPD with metallic frameworkOther
Indirectly CAD/CAM produced metallic RPD
| Study group | Role | What they receive |
|---|---|---|
| RPD with metallic framework | Active comparator | Indirectly CAD/CAM produced Metallic framework Receives: Other: RPD with metallic framework |
| RPD with PEEK framework | Experimental | Indirectly CAD/CAM produced PEEK framework Receives: Other: RPD with PEEK framework |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Health Related Quality of Life (OHRQoL)
measured by Oral Health Impact Profile- 14 Minimum score 0 , Maximum score 56 higher scores indicate worse OHRQoL
Measured: 2 years
Secondary outcomes (1)
Cost effectiveness
measured from OHRQoL as effect of treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start10 Oct 2021
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
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 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, Hend Mahmoud Mohamed Hegazi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789627
- Sponsor's protocol ID
- HendHegazi
- Status last verified
- Mar 2021
- First submitted
- 17 Jan 2025
- Last updated
- 29 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indirect CAD/CAM Removable Partial Denture Frameworks: a Comparative Study
- ClinicalTrials.gov ID
- NCT06789627
- Acronym / sponsor ID
- HendHegazi
- Keywords
- CAD/CAM, Digital metallic RPD, patient centered outcomes, 3D printing, PEEK, OHIP-14
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 23 Jan 2025 (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.
The aim of this study was to compare CAD Poly ether ether ketone (PEEK) RPD to CAD metallic RPD in treating partial edentulism in terms of Oral health related quality of life
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 metallic frameworkIndirectly CAD/CAM produced Metallic framework |
| RPD with PEEK framework | Experimental | Other: RPD with PEEK frameworkIndirectly CAD/CAM produced PEEK framework |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with bilateral free end saddles in the mandible (Kennedy class I) with the last standing abutment second premolar
- Opposing dentition is fully intact or restored to be intact
- Adequate inter-arch space of at least 7mm
- Angle's class I maxilla-mandibular relationship
- Patients with no periodontal disease and good oral hygiene
Key exclusion criteria (4 listed)
- Periodontal affection of the abutment teeth
- Skeletal mal-relationship
- Unmotivated patients to maintain adequate oral hygiene and to follow up---- ---- Patients with neuro-mascular disorders
- Systemic disease affecting periodontal health like uncontrolled diabetes
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 frameworkIndirectly CAD/CAM produced PEEK framework | Other | RPD with PEEK framework |
| RPD with metallic frameworkIndirectly CAD/CAM produced metallic RPD | Other | RPD with metallic framework |
Primary outcome
Oral Health Related Quality of Life (OHRQoL)
Time frame: 2 years
measured by Oral Health Impact Profile- 14 Minimum score 0 , Maximum score 56 higher scores indicate worse OHRQoL
1 secondary outcome
Cost effectiveness
Time frame: 1 year
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 29 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 RPD with PEEK framework and RPD with metallic framework in people with Partial Edentulism and Oral Health-Related Quality of Life, 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 6 inclusion and 4 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 29 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?
Oral Health Related Quality of Life (OHRQoL) (time frame: 2 years). 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 29 Jul 2026.