Device MalfunctionNCT06527053
Digital Obturators in Maxillectomy Cases
A study testing obturator in people with Device Malfunction, run by Tanta University at 1 site in Egypt.
Trial summary
Using Digital approach to treat patients with maxillofacial defects without surgical intervention Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Device Malfunction
- What is being tested?
- obturator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Dec 2021to 7 Jan 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
- All participants in this study will be selected according to the following criteria:
- Patients with maxillary defects Class I and class II Aramany Classification with completely healed tissues.
- Patients' age ranging from 20 to 70 years old.
- Nearly intact mandibular arch.
Who cannot join
- -
- Participants with the following criteria will be excluded from the study:
- Physical or mental instability.
- Completely edentulous patients.
- Patients presenting allergy to materials being used.
- Patients lacking compliance to maintain acceptable oral hygiene.
- Patients taking radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Digital Versus Conventional Roofless Obturators in Partial Maxillectomy Cases
Using Digital approach to treat patients with maxillofacial defects without surgical intervention
Read the detailed description
Evaluating digital dental and maxillofacial obturators to artifitially close maxillofacial defects in paients with oral cancer and patients with mucormycosis fungal post covid infection.
Craeting Digitized database for all patients included in the study.
Recording casses with post covid infection in specific period.
- Conditions
- Device Malfunction
- Being tested
- obturator
- Keywords
- digital obturators-roofless design-maxillectomy-mucorycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obturatorDevice
special maxillofacial device to close hollow defects
| Study group | Role | What they receive |
|---|---|---|
| digital obturator | Experimental | new approach to create device Receives: Device: obturator |
| conventional obturator | Experimental | old approach to create device Receives: Device: obturator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of hypernasality in speech
physiologic parameter
Measured: one month
Evaluation of masseter muscle muscle
physiologic parameter
Measured: three months
Evaluation of Patient Quality of Life
questionnaire
Measured: six months
Evaluation of retention
descriptive by KP scale
Measured: 1 day (at time of device insertion)
Obturator misfit
descriptive by Digital software
Measured: 1 day (at time of device delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start21 Dec 2021
- Primary completion1 May 2022
- Study completion7 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device MalfunctionStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients with maxillary defects had received two types of obturators
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Nasr, Tanta University
- Investigators
- ali al shaikh, professor, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527053
- Sponsor's protocol ID
- RP08-21\4
- Status last verified
- Jul 2024
- First submitted
- 15 Apr 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Digital Versus Conventional Roofless Obturators in Partial Maxillectomy Cases
- ClinicalTrials.gov ID
- NCT06527053
- Acronym / sponsor ID
- RP08-21\4
- Conditions
- Device Malfunction
- Keywords
- digital obturators-roofless design-maxillectomy-mucorycosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 21 Dec 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 7 Jan 2024 (actual)
- First posted
- 30 Jul 2024 (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.
Using Digital approach to treat patients with maxillofacial defects without surgical intervention
Detailed description
Evaluating digital dental and maxillofacial obturators to artifitially close maxillofacial defects in paients with oral cancer and patients with mucormycosis fungal post covid infection.
Craeting Digitized database for all patients included in the study.
Recording casses with post covid infection in specific period.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- patients with maxillary defects had received two types of obturators
| Arm | Type | Receives |
|---|---|---|
| digital obturator | Experimental | Device: obturatornew approach to create device |
| conventional obturator | Experimental | Device: obturatorold approach to create device |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -
- Patients with maxillary defects Class I and class II Aramany Classification with completely healed tissues.
- Patients' age ranging from 20 to 70 years old.
- Nearly intact mandibular arch.
Key exclusion criteria (7 listed)
- -
- Physical or mental instability.
- Completely edentulous patients.
- Patients presenting allergy to materials being used.
- Patients lacking compliance to maintain acceptable oral hygiene.
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 |
|---|---|---|
| obturatorspecial maxillofacial device to close hollow defects | Device | conventional obturator, digital obturator |
Primary outcome
Evaluation of hypernasality in speech
Time frame: one month
physiologic parameter
Evaluation of masseter muscle muscle
Time frame: three months
physiologic parameter
Evaluation of Patient Quality of Life
Time frame: six months
questionnaire
Evaluation of retention
Time frame: 1 day (at time of device insertion)
descriptive by KP scale
Obturator misfit
Time frame: 1 day (at time of device delivery)
descriptive by Digital software
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 30 Jul 2024.
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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.
ali al shaikh, professor 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 obturator in people with Device Malfunction, 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 5 inclusion and 7 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 30 Jul 2024. 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?
Evaluation of hypernasality in speech (time frame: one month). The study lists 5 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 30 Jul 2024.