Patient SatisfactionNCT06070727
Polyetherketoneketone and Metal Framework for Management of Maxillectomy Cases: Across Over Study
A study testing Obturator in people with Patient Satisfaction, run by Mansoura University at 1 site in Egypt.
Trial summary
Prosthetic rehabilitation of acquired maxillary defects represents a challenging mission for both the prosthodontist and psychologically traumatized patients. These defects may be due to trauma, pathological conditions, or surgical resection of oral tumors. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction
- What is being tested?
- Obturator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jul 2023to 4 Aug 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient will be selected according to the following criteria:
- Patient with unilateral total maxillectomy.
- Patients will have sufficient number of remaining teeth.
- Free from any signs of inflammation in defect area.
- Patient 3 years after receiving radiation.
- The defect size is small or large.
- Patient with susceptibility of recurrence.
Who cannot join
- Patient is still receiving radiation.
- Defect result from trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework for Management of Maxillectomy Cases: Across Over Study
Prosthetic rehabilitation of acquired maxillary defects represents a challenging mission for both the prosthodontist and psychologically traumatized patients. These defects may be due to trauma, pathological conditions, or surgical resection of oral tumors. The resulting main problem is oronasal communication leading to impairment in mastication, swallowing, speech, and facial esthetics
Read the detailed description
Maxillary obturator prostheses are usually fabricated from polymethyl methacrylate (PMMA) if the patient is completely edentulous, or from PMMA and a cast frame-work if partially edentulous. As the size of the surgical resection increases, the weight of the prosthesis also increases. Traditionally, the weight of the prosthesis has been minimized through the use of hollow bulb obturators and change of manufacturing material.
Polyetherketoneketone (PEKK) has been widely tested in a number of dental applications, such as PEKK dental implants, PEKK obturators, and PEEK RPD frameworks. PEKK has a relatively low Young's modulus of 3 to 4 GPa, which is close to that of human bones, and its tensile properties are similar to those of bone, enamel, and dentin. These properties make it a suitable material for fixed and removable prostheses.(6-8) PEKK is a lightweight material with excellent biocompatibility as it can be used in combination with Computer-aided design/computer-assisted manufacturing (CAD/CAM) in fabrication of maxillofacial prostheses.(9) So the aim of this study will be, evaluation of Patient satisfaction and oral healthy related quality of life of PEKK and metal framework for management of maxillectomy cases. The null hypothesis is that, there would be no significant difference between both frameworks.
- Conditions
- Patient Satisfaction
- Being tested
- Obturator
- Keywords
- Polyetherketoneketone, Metal, Obturator
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObturatorOther
Evaluation of patient satisfaction and oral healthy related quality of life of Polyetherketoneketone(PEKK) and metal framework for management of maxillectomy cases.
| Study group | Role | What they receive |
|---|---|---|
| Metal framework group | Other | group A: Patients will receive metallic framework with obturator for 6 months, then the metallic obturator will be replaced by PEKK obturator for another 6 months. Receives: Other: Obturator |
| PEKK framework group | Other | Group B: Patients will receive PEKK obturator for 6 months, then the same patients will receive metallic framework obturator for another 6 months. Receives: Other: Obturator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Obturator functioning scale (OFS) used for evaluation of patient satisfaction, such as improvement in speech, better swallowing with the obturator, feeling and appearance of the upper lip, general feeling in the mouth, self confidence, and avoidance of social family events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start4 Jul 2023
- Primary completion4 Jul 2024 (estimated)
- Study completion4 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070727
- Sponsor's protocol ID
- M0107023RP
- Status last verified
- Jul 2023
- First submitted
- 20 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Oral Healthy Related Quality of Life of Polyetherketoneketone and Metal Framework for Management of Maxillectomy Cases: Across Over Study
- ClinicalTrials.gov ID
- NCT06070727
- Acronym / sponsor ID
- M0107023RP
- Conditions
- Patient Satisfaction
- Keywords
- Polyetherketoneketone, Metal, Obturator
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 4 Jul 2024 (estimated)
- Study completion
- 4 Aug 2024 (estimated)
- First posted
- 6 Oct 2023 (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.
Prosthetic rehabilitation of acquired maxillary defects represents a challenging mission for both the prosthodontist and psychologically traumatized patients. These defects may be due to trauma, pathological conditions, or surgical resection of oral tumors. The resulting main problem is oronasal communication leading to impairment in mastication, swallowing, speech, and facial esthetics
Detailed description
Maxillary obturator prostheses are usually fabricated from polymethyl methacrylate (PMMA) if the patient is completely edentulous, or from PMMA and a cast frame-work if partially edentulous. As the size of the surgical resection increases, the weight of the prosthesis also increases. Traditionally, the weight of the prosthesis has been minimized through the use of hollow bulb obturators and change of manufacturing material.
Polyetherketoneketone (PEKK) has been widely tested in a number of dental applications, such as PEKK dental implants, PEKK obturators, and PEEK RPD frameworks. PEKK has a relatively low Young's modulus of 3 to 4 GPa, which is close to that of human bones, and its tensile properties are similar to those of bone, enamel, and dentin. These properties make it a suitable material for fixed and removable prostheses.(6-8) PEKK is a lightweight material with excellent biocompatibility as it can be used in combination with Computer-aided design/computer-assisted manufacturing (CAD/CAM) in fabrication of maxillofacial prostheses.(9) So the aim of this study will be, evaluation of Patient satisfaction and oral healthy related quality of life of PEKK and metal framework for management of maxillectomy cases. The null hypothesis is that, there would be no significant difference between both frameworks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metal framework group | Other | Other: Obturatorgroup A: Patients will receive metallic framework with obturator for 6 months, then the metallic obturator will be replaced by PEKK obturator for another 6 months. |
| PEKK framework group | Other | Other: ObturatorGroup B: Patients will receive PEKK obturator for 6 months, then the same patients will receive metallic framework obturator for another 6 months. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with unilateral total maxillectomy.
- Patients will have sufficient number of remaining teeth.
- Free from any signs of inflammation in defect area.
- Patient 3 years after receiving radiation.
- The defect size is small or large.
Key exclusion criteria (2 listed)
- Patient is still receiving radiation.
- Defect result from trauma.
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 |
|---|---|---|
| ObturatorEvaluation of patient satisfaction and oral healthy related quality of life of Polyetherketoneketone(PEKK) and metal framework for management of maxillectomy cases. | Other | Metal framework group, PEKK framework group |
Primary outcome
Patient satisfaction
Time frame: 6 months
Obturator functioning scale (OFS) used for evaluation of patient satisfaction, such as improvement in speech, better swallowing with the obturator, feeling and appearance of the upper lip, general feeling in the mouth, self confidence, and avoidance of social family events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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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 Obturator in people with Patient Satisfaction, run by Mansoura 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 7 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: status not confirmed, as of the sponsor's last update on 6 Oct 2023. 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?
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?
Patient satisfaction (time frame: 6 months). 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 6 Oct 2023.