Maxillary DiseasesNCT06934551
Patient Satisfaction & Abutment Teeth Health in Maxillectomy Patients
A study testing obturator in people with Maxillary Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
randomized controlled trial in maxillectomy patients with two types of obturators with different manufacturing techniques Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Maxillary Diseases
- What is being tested?
- obturator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with hemi maxillectomy
- Sufficient number of natural teeth not less than 5 teeth
- Age between 30 and 60 years
- Intact soft palate
Who cannot join
- Cognitive impairment
- Heavy smokers
- Patients exposed to radiotherapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 02
nehal elsherif, 01001982995, nehal.elsherif@dentistry.cu.edu.eg
About this study
Official title: Patient Satisfaction & Abutment Teeth Health in Maxillectomy Patients Rehabilitated With Laser CAD CAM & Conventionally Constructed Obturators
randomized controlled trial in maxillectomy patients with two types of obturators with different manufacturing techniques
Read the detailed description
randomized controlled trial measuring patient satisfaction and abutment teeth health in maxillectomy patients rehabilitated with laser polished CAD CAM obturators versus conventionally constructed obturators
- Conditions
- Maxillary Diseases
- Being tested
- obturator
- Medical subject headings
- Maxillary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obturatorDevice
Also called conventionally constructed obturator
conventionally constructed and polished obturator
| Study group | Role | What they receive |
|---|---|---|
| CAD CA laser polished obturator | Experimental | the intervention obturator is to be made digitally with CAD CAM technology then laser polished Receives: Device: obturator |
| conventionally constructed obturator | Active comparator | the control group will receive conventionally constructed obturator Receives: Device: obturator |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
will be assessed by 5-point Likert scale capturing various degrees of opinion from strongly disagree, disagree, neutral agree, to strongly agree. data will be collected and sent to statistician for the analysis required in mean difference and standard deviation.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start10 Dec 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary DiseasesStudies 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
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nehal Abdelrahim Amin Elsherif, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934551
- Sponsor's protocol ID
- 1224
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 18 Apr 2025
- 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction & Abutment Teeth Health in Maxillectomy Patients Rehabilitated With Laser CAD CAM & Conventionally Constructed Obturators
- ClinicalTrials.gov ID
- NCT06934551
- Acronym / sponsor ID
- 1224
- Conditions
- Maxillary Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Apr 2025 (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.
randomized controlled trial in maxillectomy patients with two types of obturators with different manufacturing techniques
Detailed description
randomized controlled trial measuring patient satisfaction and abutment teeth health in maxillectomy patients rehabilitated with laser polished CAD CAM obturators versus conventionally constructed obturators
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD CA laser polished obturator | Experimental | Device: obturatorthe intervention obturator is to be made digitally with CAD CAM technology then laser polished |
| conventionally constructed obturator | Active comparator | Device: obturatorthe control group will receive conventionally constructed obturator |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with hemi maxillectomy
- Sufficient number of natural teeth not less than 5 teeth
- Age between 30 and 60 years
- Intact soft palate
Key exclusion criteria (3 listed)
- Cognitive impairment
- Heavy smokers
- Patients exposed to radiotherapy
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 |
|---|---|---|
| obturatorAlso: conventionally constructed obturatorconventionally constructed and polished obturator | Device | CAD CA laser polished obturator, conventionally constructed obturator |
Primary outcome
patient satisfaction
Time frame: 3 months
will be assessed by 5-point Likert scale capturing various degrees of opinion from strongly disagree, disagree, neutral agree, to strongly agree. data will be collected and sent to statistician for the analysis required in mean difference and standard deviation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- 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.
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 Maxillary Diseases, 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: 3 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 18 Apr 2025.