Partially Edentulous MandiblePEEKNCT05079048
PEEK Retentive Elements Versus Conventional
A study testing PEEK retentive elements in people with Partially Edentulous Mandible, run by Cairo University at 1 site in Egypt.
Trial summary
comparing retention and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Partially Edentulous Mandible
- What is being tested?
- PEEK retentive elements
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 30 Nov 2019
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- edentulous class I or II PDI classification no neuromuscular disordersand temporomandibular joint disorders
Who cannot join
- exposed to radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel PEEK Retentive Elements Versus Conventional Retentive Elements in Mandibular Overdentures: A Randomized Controlled Trial
comparing retention and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings
Read the detailed description
Background. Many patients suffer from lack of retention of conventional mandibular overdentures due to loss of clip retention over time. Computer-aided design-computer-aided manufacturing (CAD-CAM) milled polyetheretherketone PEEK materials may be used for construction of retentive housing and clip for improving retention of implant-supported overdentures.
Objective . To compare retention and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings.
Methods: Twenty-two participants were divided into 2 equal groups (n=11). The conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements, while the PEEK group received implant-supported mandibular overdenture retained by PEEK retentive element and housings.The PEEK retentive elements were made by using computer-aided design and computer-aided manufacturing (CAD-CAM).Evaluation included measuring the retention by applying a gradual pulling up force by forcemeter and patient satisfaction with a 7-point visual analog scale (VAS) at overdenture insertion , 3,6, and 12 months subsequently by research interviewer.
- Conditions
- Partially Edentulous Mandible
- Being tested
- PEEK retentive elements
- Keywords
- Ball attachment, overdenture, patient satisfaction, PEEK, retention measurement.
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK retentive elementsOther
Also called PEEK housing and clip
received implant-supported mandibular overdenture retained by PEEK retentive element and housings
| Study group | Role | What they receive |
|---|---|---|
| conventional retentive element | Active comparator | The conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements, Receives: Other: PEEK retentive elements |
| PEEK retentive element | Experimental | PEEK group received implant-supported mandibular overdentures retained by PEEK housings , Receives: Other: PEEK retentive elements |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention
measuring retention force of retentive elements using The force-meter machine (Eagle: ELT 3000) . Gradual pulling up force was applied. The record appeared at the screen of the force meter was recorded as it's single-blind measurements.
Measured: 3 months to six months
Secondary outcomes (1)
patient satisfaction
measuring patient satisfaction using Visual analog scale (VAS) was used for the evaluation of overall patient satisfaction. All questionnaires were taken by the same research interviewer (assisted interviewer) as he was blind about the type of prosthesis (double-blind) as the research interviewer is from another department
Measured: 3 months to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Jul 2017
- Primary completion1 Apr 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partially Edentulous MandibleStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharaf Mohamed Yahia, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079048
- Sponsor's protocol ID
- 19/5/2020
- Acronym
- PEEK
- Status last verified
- Oct 2021
- First submitted
- 5 Jul 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sharaf MY, Eskander A, Afify MA. Novel PEEK Retentive Elements versus Conventional Retentive Elements in Mandibular Overdentures: A Randomized Controlled Trial. Int J Dent. 2022 Feb 28;2022:6947756. doi: 10.1155/2022/6947756. eCollection 2022.
PubMed 35265135
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel PEEK Retentive Elements Versus Conventional Retentive Elements in Mandibular Overdentures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05079048
- Acronym / sponsor ID
- PEEK / 19/5/2020
- Conditions
- Partially Edentulous Mandible
- Keywords
- Ball attachment, overdenture, patient satisfaction, PEEK, retention measurement.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 15 Oct 2021 (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 and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings
Detailed description
Background. Many patients suffer from lack of retention of conventional mandibular overdentures due to loss of clip retention over time. Computer-aided design-computer-aided manufacturing (CAD-CAM) milled polyetheretherketone PEEK materials may be used for construction of retentive housing and clip for improving retention of implant-supported overdentures.
Objective . To compare retention and patient satisfaction of implant-supported mandibular overdentures retained by conventional nylon clip and metal housings for ball attachments versus PEEK clip and housings.
Methods: Twenty-two participants were divided into 2 equal groups (n=11). The conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements, while the PEEK group received implant-supported mandibular overdenture retained by PEEK retentive element and housings.The PEEK retentive elements were made by using computer-aided design and computer-aided manufacturing (CAD-CAM).Evaluation included measuring the retention by applying a gradual pulling up force by forcemeter and patient satisfaction with a 7-point visual analog scale (VAS) at overdenture insertion , 3,6, and 12 months subsequently by research interviewer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional retentive element | Active comparator | Other: PEEK retentive elementsThe conventional group received implant-supported mandibular overdentures retained by metal housings and nylon retentive elements, |
| PEEK retentive element | Experimental | Other: PEEK retentive elementsPEEK group received implant-supported mandibular overdentures retained by PEEK housings , |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- edentulous class I or II PDI classification no neuromuscular disordersand temporomandibular joint disorders
Key exclusion criteria (1 listed)
- exposed to radiotherapy
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 retentive elementsAlso: PEEK housing and clipreceived implant-supported mandibular overdenture retained by PEEK retentive element and housings | Other | PEEK retentive element, conventional retentive element |
Primary outcome
retention
Time frame: 3 months to six months
measuring retention force of retentive elements using The force-meter machine (Eagle: ELT 3000) . Gradual pulling up force was applied. The record appeared at the screen of the force meter was recorded as it's single-blind measurements.
1 secondary outcome
patient satisfaction
Time frame: 3 months to six months
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 15 Oct 2021.
- Derived from this study: PubMed 35265135Sharaf MY, Eskander A, Afify MA. Novel PEEK Retentive Elements versus Conventional Retentive Elements in Mandibular Overdentures: A Randomized Controlled Trial. Int J Dent. 2022 Feb 28;2022:6947756. doi: 10.1155/2022/6947756. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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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 retentive elements in people with Partially Edentulous Mandible, 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 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 15 Oct 2021. 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?
retention (time frame: 3 months to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05079048, which also lists 1 linked publication.
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 15 Oct 2021.