Maxillofacial Prosthesis UserNCT05920811
Patient Satisfaction for Digital Versus Conventional Maxillary Obturator
A study testing conventional obturator and 3 d printed obturator in people with Maxillofacial Prosthesis User, run by Tanta University at 1 site in Egypt.
Trial summary
Evidence regarding the performance of digital obturators totally fabricated using 3D printing is insufficient. This prospective randomized crossover study aimed to evaluate patient satisfaction with conventional maxillary obturator and totally full digitally fabricated obturator. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillofacial Prosthesis User
- What is being tested?
- conventional obturator and 3 d printed obturator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 15 Jun 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with hemimaxillectomy defect (Aramany class 1)
- almost edentulous mandible with healthy remaining teeth,
- mouth opening is not less than 25 mm, intact soft palate
- participants were not exposed to radiotherapy or chemotherapy in the previous year
Who cannot join
- patients with physical or mental disorders.
- patients still receiving radio or chemotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Satisfaction With Conventional Maxillary Obturator Versus Fully Digital Fabricated With 3D Printing: a Randomized Crossover Trial
Evidence regarding the performance of digital obturators totally fabricated using 3D printing is insufficient. This prospective randomized crossover study aimed to evaluate patient satisfaction with conventional maxillary obturator and totally full digitally fabricated obturator. Patient satisfaction was evaluated using two scales: The Obturator Functioning Scale" and "The Patient and operator-centered outcomes were assessed through two visual analog scale (VAS) questionnaires.
Read the detailed description
The use of digital technologies in the fabrication of maxillofacial prostheses has been described. Additive manufacturing offers a more convenient and more efficient process with reduced material waste compared with traditional subtractive technique. Although Prosthetic rehabilitation with Conventional maxillary obturator prosthesis fabricated with a casted metal framework using, heat-cured acrylic resin can restore oral function and facial esthetics following maxillectomy. But it is time-consuming and labor-intensive. Multiple sources of errors can accumulate during the laboratory steps, resulting in a misfit of the framework. In this study All patients received a conventional obturator for 6 months, after a washout period of one week, they use the digital one. The Obturator Functioning Scale" and "The Patient and operator-centered outcomes were assessed through two visual analog scale (VAS) questionnaires.
- Conditions
- Maxillofacial Prosthesis User
- Being tested
- conventional obturator, 3 d printed obturator
- Keywords
- maxillary obturator, selective laser melting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional obturatorOther
restoration of midline maxillary defect with obturator made of cast metal , heat cure acrylic resin
3 d printed obturatorOther
restoration of midline maxillary defect with obturator made of SLM metal , 3 d printed resin
| Study group | Role | What they receive |
|---|---|---|
| conventional obturator | Active comparator | maxillary obturator fabricated from cast metal framework, heat-cured acrylic resin Receives: Other: conventional obturator |
| 3 d printed obturator | Experimental | 3d printed obturator with full digital workflow ( intraoral scanning, made of selective laser melting, 3d printed resin Receives: Other: 3 d printed obturator |
What is being measured
The primary outcome is the main question the study is designed to answer.
obturator functioning scale
The Obturator Functioning Scale ( minimum value is "1"and maximum value is "5"
Measured: 6 months
patient outcome the treatment time, on the self-perception of the applied impression protocol in terms of general convenience, anxiety, taste, nausea sensation and possible pain sensation.
questions focused on general convenience, anxiety, taste, nausea sensation and possible pain sensation, assessed through visual analogue scale (VAS)
Measured: 6 months
operator outcome
Questions focused on the treatment time, on the self-perception of the applied impression
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 posted27 Jun 2023
- Study start1 Apr 2022
- Primary completion1 May 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillofacial Prosthesis UserStudies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohammed Amer, Tanta University
- Investigators
- marwa M Amer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920811
- Sponsor's protocol ID
- prosth 6/23
- Status last verified
- Jun 2023
- First submitted
- 17 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction With Conventional Maxillary Obturator Versus Fully Digital Fabricated With 3D Printing: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05920811
- Acronym / sponsor ID
- prosth 6/23
- Conditions
- Maxillofacial Prosthesis User
- Keywords
- maxillary obturator, selective laser melting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 27 Jun 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.
Evidence regarding the performance of digital obturators totally fabricated using 3D printing is insufficient. This prospective randomized crossover study aimed to evaluate patient satisfaction with conventional maxillary obturator and totally full digitally fabricated obturator. Patient satisfaction was evaluated using two scales: The Obturator Functioning Scale" and "The Patient and operator-centered outcomes were assessed through two visual analog scale (VAS) questionnaires.
Detailed description
The use of digital technologies in the fabrication of maxillofacial prostheses has been described. Additive manufacturing offers a more convenient and more efficient process with reduced material waste compared with traditional subtractive technique. Although Prosthetic rehabilitation with Conventional maxillary obturator prosthesis fabricated with a casted metal framework using, heat-cured acrylic resin can restore oral function and facial esthetics following maxillectomy. But it is time-consuming and labor-intensive. Multiple sources of errors can accumulate during the laboratory steps, resulting in a misfit of the framework. In this study All patients received a conventional obturator for 6 months, after a washout period of one week, they use the digital one. The Obturator Functioning Scale" and "The Patient and operator-centered outcomes were assessed through two visual analog scale (VAS) questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional obturator | Active comparator | Other: conventional obturatormaxillary obturator fabricated from cast metal framework, heat-cured acrylic resin |
| 3 d printed obturator | Experimental | Other: 3 d printed obturator3d printed obturator with full digital workflow ( intraoral scanning, made of selective laser melting, 3d printed resin |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- patients with hemimaxillectomy defect (Aramany class 1)
- almost edentulous mandible with healthy remaining teeth,
- mouth opening is not less than 25 mm, intact soft palate
- participants were not exposed to radiotherapy or chemotherapy in the previous year
Key exclusion criteria (2 listed)
- patients with physical or mental disorders.
- patients still receiving radio or chemotherapy
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 |
|---|---|---|
| conventional obturatorrestoration of midline maxillary defect with obturator made of cast metal , heat cure acrylic resin | Other | conventional obturator |
| 3 d printed obturatorrestoration of midline maxillary defect with obturator made of SLM metal , 3 d printed resin | Other | 3 d printed obturator |
Primary outcome
obturator functioning scale
Time frame: 6 months
The Obturator Functioning Scale ( minimum value is "1"and maximum value is "5"
patient outcome the treatment time, on the self-perception of the applied impression protocol in terms of general convenience, anxiety, taste, nausea sensation and possible pain sensation.
Time frame: 6 months
questions focused on general convenience, anxiety, taste, nausea sensation and possible pain sensation, assessed through visual analogue scale (VAS)
operator outcome
Time frame: 6 months
Questions focused on the treatment time, on the self-perception of the applied impression
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 27 Jun 2023.
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.
marwa M Amer principal investigator
Tanta 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 conventional obturator and 3 d printed obturator in people with Maxillofacial Prosthesis User, run by Tanta 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 4 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 27 Jun 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?
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?
obturator functioning scale (time frame: 6 months). The study lists 3 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 27 Jun 2023.