Maxilla--CancerobturatorNCT04881669
The Effect of Obturator Thickness on the Function
A study testing obturator in people with Maxilla--Cancer, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
the effect of obturator bulb thickness on masticatory function has been verified. Read more about this study
- Who is it for?
- Ages 16 to 71 years
- Conditions the study is for
- Maxilla--Cancer
- What is being tested?
- obturator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Mar 2019to 12 Sep 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 16 to 71 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- having maxillectomy operation
Who cannot join
- having radiation therapy before the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul university,Faculty of Dentistry
Fatih, 34452
About this study
Official title: The Effect of the Wall Thickness of Obturator Bulbs on Masticatory Function in Patients With Maxillectomy
the effect of obturator bulb thickness on masticatory function has been verified.
- Conditions
- Maxilla--Cancer
- Being tested
- obturator
- Keywords
- obturator, bulb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obturatorDevice
Also called bulb
variable bulbs
| Study group | Role | What they receive |
|---|---|---|
| low group | Experimental | low thickness group Receives: Device: obturator |
| moderate group | Experimental | moderate thickness group Receives: Device: obturator |
| high group | Experimental | high thickness group Receives: Device: obturator |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of bulb thickness
measuring the efficacy of masticatory function with chewing test
Measured: 3 weeks
the effect of weight reduction
measuring the weight differences of prostheses
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start6 Mar 2019
- Primary completion22 Jul 2019
- Study completion12 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxilla--CancerStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Merve Benli, Istanbul University
- Investigators
- merve benli, phd, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881669
- Sponsor's protocol ID
- 1297
- Acronym
- obturator
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Wall Thickness of Obturator Bulbs on Masticatory Function in Patients With Maxillectomy
- ClinicalTrials.gov ID
- NCT04881669
- Acronym / sponsor ID
- obturator / 1297
- Conditions
- Maxilla--Cancer
- Keywords
- obturator, bulb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 11 May 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.
the effect of obturator bulb thickness on masticatory function has been verified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low group | Experimental | Device: obturatorlow thickness group |
| moderate group | Experimental | Device: obturatormoderate thickness group |
| high group | Experimental | Device: obturatorhigh thickness group |
Who may qualify
- Ages
- 16 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- having maxillectomy operation
Key exclusion criteria (1 listed)
- having radiation therapy before the study
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: bulbvariable bulbs | Device | high group, low group, moderate group |
Primary outcome
the effect of bulb thickness
Time frame: 3 weeks
measuring the efficacy of masticatory function with chewing test
the effect of weight reduction
Time frame: 3 weeks
measuring the weight differences of prostheses
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 11 May 2021.
- Individual participant dataSharing planned: Yes
Related trials for Maxilla--Cancer
Active, not recruitingPhase 2
Customized 3D Printed Oral Stents During Head and Neck Radiotherapy
Head and Neck Carcinoma, Malignant Parotid Gland Neoplasm
RecruitingPhase 1
Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Active, not recruiting
3D-Printed Patient-Specific Surgical Plates Versus Conventional Surgical Plates in Jaw Reconstruction
Mandibular Neoplasms, Maxillary Neoplasms
Enrolling by invitation
Results of Different Modalities of Palatomaxillary Reconstruction
Cancer Maxilla
Not yet recruitingPhase 3
Using of Bone Marrow Stem Cell Concentrate with Platelet Rich Fibrin and Bone Graft in Bone Reconstruction of Upper Jaw Bony Cystic Defects, Comparing with Platelet Rich Fibrin with Bone Graft
Maxillary Cyst
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.
merve benli, phd study director
Istanbul 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 Maxilla--Cancer, run by Istanbul University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 11 May 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 Turkey (Türkiye). 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?
the effect of bulb thickness (time frame: 3 weeks). 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 11 May 2021.