Maxillary NeoplasmsPEEKNCT04778254
PEEK Versus Metallic Attachment-retained Obturators
A study testing PEEK attachment retained obturator, metalic attachment retained obturator and conventional obturator in people with Maxillary Neoplasms, run by Cairo University at 1 site in Egypt.
Trial summary
Patients' satisfaction evaluation and radiographic evaluation of the terminal abutments of attachment- retained maxillary obturators with metal framework versus milled PEEK framework in the management of maxillectomy cases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Maxillary Neoplasms
- What is being tested?
- PEEK attachment retained obturator, metalic attachment retained obturator and conventional obturator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 30 Aug 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
- patient underwent surgical removal of half of maxilla
- participants with a sufficient number of natural teeth(class I and \or class IV Aramany classification) not less than 5 teeth, mouth opening is not less than 25 mm, intact soft palate,
Who cannot join
- participants are exposed to radiotherapy or chemotherapy during last year.
- participant with congenital defect
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PEEK Versus Metallic Attachment-retained Obturators Regarding Patient Satisfaction: A Randomized Controlled Trial.
Patients' satisfaction evaluation and radiographic evaluation of the terminal abutments of attachment- retained maxillary obturators with metal framework versus milled PEEK framework in the management of maxillectomy cases.
Read the detailed description
Eighteen participants were randomly divided into three parallel groups (n=6). Participants of PEEK group received attachment-retained obturators with milled PEEK framework, metal group received an attachment-retained obturator with metallic framework and conventional group received conventional clasp-retained obturators with metallic framework (Control group). Evaluation included radiographic evaluation and patients' satisfaction where two scales were followed in this study, including "The Obturator Functioning Scale" and "The European Organization for Research and Treatment of Cancer Head and Neck 35" using one way ANOVA test.
- Conditions
- Maxillary Neoplasms
- Being tested
- PEEK attachment retained obturator, metalic attachment retained obturator, conventional obturator
- Medical subject headings
- Maxillary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK attachment retained obturatorOther
Also called milled PEEK obturator
attachment retained obturator for management of hemi maxillectomy
metalic attachment retained obturatorOther
Also called attachment retained obturator
attachment retained obturator for management of hemi maxillectomy
conventional obturatorOther
Also called clasp retained obturator
clasp retained obturator for management of hemi maxillectomy
| Study group | Role | What they receive |
|---|---|---|
| conventional obturator | Active comparator | conventional group received conventional clasp-retained obturators with metallic framework (Control group). Receives: Other: conventional obturator |
| metallic attachment retained obturator | Experimental | metal group received an attachment-retained obturator with metallic framework Receives: Other: metalic attachment retained obturator |
| PEEk attachment retained obturator | Experimental | PEEK group received attachment-retained obturators with milled PEEK framework, Receives: Other: PEEK attachment retained obturator |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction 1(change" is being assessed)
The Obturator Functioning Scale ( minimum value is "1"and maximum value is "5"
Measured: 1 week to 6 months
patient satisfaction 2 (change" is being assessed)
The European Organization for Research and Treatment of Cancer Head and Neck 35 ( minimum value is "1"and maximum value is "5"
Measured: 1 week to 6 months
Secondary outcomes (1)
Radiographic evaluation (change" is being assessed)
evaluation of terminal abutment
Measured: base line,6 months, 9 months,12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Feb 2018
- Primary completion1 Jul 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary NeoplasmsStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharaf Mohamed Yahia, Cairo University
- Investigators
- Mohamed Sharaf, lecturer, Principal investigator, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778254
- Sponsor's protocol ID
- 38/10/2018
- Acronym
- PEEK
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: finished work will be published
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEEK Versus Metallic Attachment-retained Obturators Regarding Patient Satisfaction: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04778254
- Acronym / sponsor ID
- PEEK / 38/10/2018
- Conditions
- Maxillary Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 3 Mar 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.
Patients' satisfaction evaluation and radiographic evaluation of the terminal abutments of attachment- retained maxillary obturators with metal framework versus milled PEEK framework in the management of maxillectomy cases.
Detailed description
Eighteen participants were randomly divided into three parallel groups (n=6). Participants of PEEK group received attachment-retained obturators with milled PEEK framework, metal group received an attachment-retained obturator with metallic framework and conventional group received conventional clasp-retained obturators with metallic framework (Control group). Evaluation included radiographic evaluation and patients' satisfaction where two scales were followed in this study, including "The Obturator Functioning Scale" and "The European Organization for Research and Treatment of Cancer Head and Neck 35" using one way ANOVA test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional obturator | Active comparator | Other: conventional obturatorconventional group received conventional clasp-retained obturators with metallic framework (Control group). |
| metallic attachment retained obturator | Experimental | Other: metalic attachment retained obturatormetal group received an attachment-retained obturator with metallic framework |
| PEEk attachment retained obturator | Experimental | Other: PEEK attachment retained obturatorPEEK group received attachment-retained obturators with milled PEEK framework, |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patient underwent surgical removal of half of maxilla
- participants with a sufficient number of natural teeth(class I and \or class IV Aramany classification) not less than 5 teeth, mouth opening is not less than 25 mm, intact soft palate,
Key exclusion criteria (2 listed)
- participants are exposed to radiotherapy or chemotherapy during last year.
- participant with congenital defect
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 attachment retained obturatorAlso: milled PEEK obturatorattachment retained obturator for management of hemi maxillectomy | Other | PEEk attachment retained obturator |
| metalic attachment retained obturatorAlso: attachment retained obturatorattachment retained obturator for management of hemi maxillectomy | Other | metallic attachment retained obturator |
| conventional obturatorAlso: clasp retained obturatorclasp retained obturator for management of hemi maxillectomy | Other | conventional obturator |
Primary outcome
patient satisfaction 1(change" is being assessed)
Time frame: 1 week to 6 months
The Obturator Functioning Scale ( minimum value is "1"and maximum value is "5"
patient satisfaction 2 (change" is being assessed)
Time frame: 1 week to 6 months
The European Organization for Research and Treatment of Cancer Head and Neck 35 ( minimum value is "1"and maximum value is "5"
1 secondary outcome
Radiographic evaluation (change" is being assessed)
Time frame: base line,6 months, 9 months,12 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 3 Mar 2021.
- Individual participant dataSharing planned: Undecided. finished work will be published
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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.
Mohamed Sharaf, lecturer principal investigator
Beni-Suef University
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 attachment retained obturator, metalic attachment retained obturator and conventional obturator in people with Maxillary Neoplasms, 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 2 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 3 Mar 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?
patient satisfaction 1(change" is being assessed) (time frame: 1 week to 6 months). The study lists 2 primary outcomes in all. 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 3 Mar 2021.