PolyetheretherketonesplitmouthNCT03008317
Microbial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture
A study testing PEEK in people with Polyetheretherketone, run by Cairo University.
Trial summary
a split mouth randomized clinical trial that compares quantity and quality of bacterial adhesion under both PEEK versus cobalt chromium alloy denture base. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Polyetheretherketone
- What is being tested?
- PEEK
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Dec 2017
- 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 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients are medically free
Who cannot join
- patients with badly broken abutments
About this study
a split mouth randomized clinical trial that compares quantity and quality of bacterial adhesion under both PEEK versus cobalt chromium alloy denture base.
Read the detailed description
this study aimed to compare the adhesion of microorganisms to the non metallic denture base of PEEK and metallic denture base of cobalt chromium alloy in patients with class III modification 1
- Conditions
- Polyetheretherketone
- Being tested
- PEEK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEKDevice
Also called polyetheretherketone denture base, cobalt chromium alloy denture base
a metallic denture base
| Study group | Role | What they receive |
|---|---|---|
| non metallic | Active comparator | PEEK denture base, Receives: Device: PEEK |
| metallic denture base | Placebo comparator | cobalt chromium alloy denture base Receives: Device: PEEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbial culture using number of clonies after insertion by 3 months
microbial adhesion will be measured using continous cultures to assess number of colonies
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolyetheretherketoneStudies 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
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager essam el azizi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008317
- Sponsor's protocol ID
- CEBC-CU-2016-12-164
- Acronym
- splitmouth
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2016
- Last updated
- 2 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Adhesion to Metallic Versus Non Metallic Surfaces of Bounded Removable Partial Denture
- ClinicalTrials.gov ID
- NCT03008317
- Acronym / sponsor ID
- splitmouth / CEBC-CU-2016-12-164
- Conditions
- Polyetheretherketone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Jan 2017 (estimated)
- 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.
a split mouth randomized clinical trial that compares quantity and quality of bacterial adhesion under both PEEK versus cobalt chromium alloy denture base.
Detailed description
this study aimed to compare the adhesion of microorganisms to the non metallic denture base of PEEK and metallic denture base of cobalt chromium alloy in patients with class III modification 1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non metallic | Active comparator | Device: PEEKPEEK denture base, |
| metallic denture base | Placebo comparator | Device: PEEKcobalt chromium alloy denture base |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients are medically free
Key exclusion criteria (1 listed)
- patients with badly broken abutments
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 |
|---|---|---|
| PEEKAlso: polyetheretherketone denture base, cobalt chromium alloy denture basea metallic denture base | Device | metallic denture base, non metallic |
Primary outcome
microbial culture using number of clonies after insertion by 3 months
Time frame: one year
microbial adhesion will be measured using continous cultures to assess number of colonies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Polyetheretherketone
Active, not recruiting
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RecruitingObservational study
A Prospective Observational Study of Transcranial Doppler Ultrasound in the Assessment of Cerebral Blood Flow After Polyetheretherketone Cranioplasty
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RecruitingObservational study
Prospective Observational Study on Comprehensive Effects of PEEK Cranioplasty and Titanium Cranioplasty After DC（RECEPT-DC）
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Enrolling by invitation
Clinical Performance of All-on-4 PEEK and Conventional Prostheses
Failure, Prosthesis, Dental Prosthesis, Implant-Supported
Recruiting
Removable Partial Dentures Made of PEEK
Tooth Loss
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.
Questions about this trial
What is this clinical trial studying?
A study testing PEEK in people with Polyetheretherketone, run by Cairo University.
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: status not confirmed, as of the sponsor's last update on 2 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
microbial culture using number of clonies after insertion by 3 months (time frame: one year). 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 2 Jan 2017.