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
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