Patient With Partial MaxillectomyNCT03278041
Effect of the Submental Artery Island Flap Versus Maxillary Obturator Prosthesis
A study testing Submental flap for palatal reconstruction and maxillary obturator in people with Patient With Partial Maxillectomy and Submental Island Flap, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the study is to compare maxillary obturator versus submental artery flap after partial maxillectomy in the aspect of Quality of life outcomes. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Patient With Partial Maxillectomy, Submental Island Flap, Maxillary Obturator
- What is being tested?
- Submental flap for palatal reconstruction and maxillary obturator
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jan 2018to 30 Jan 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects were required:
- All patients suffering from midface defects that involving palatal-maxillary bone are included.
- All ages and both sexes were included in this study.
- Patients with good general condition allowing major surgical procedure under general anesthesia.
- Be physically and psychologically able to tolerate procedures.
- Be cooperative to return for follow-up, examinations and evaluation.
Who cannot join
- Patient who physically and psychologically not able to tolerate procedures. Because they cannot able to tolerate procedures and may discontinue the follow-up visits.
- Be Uncooperative to return for follow-up, examinations and evaluation.
- Patients with any systemic disease (e.g uncontrolled diabetic, bisphosphonates …..ect) because that may affect normal healing.
- Patient with bad oral hygiene.Because poor oral hygiene can cause inflammation which induces pain that effect outcome reading.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry-cairo university
Cairo, 311
omar q aladashi, master, 00201154639509, omraladashi@gmail.com
About this study
Official title: Effect of the Submental Artery Island Flap Versus Maxillary Obturator Prosthesis on the Quality of Life in Patients With Palatal Defects. (Randomized Controlled Clinical Study)
The aim of the study is to compare maxillary obturator versus submental artery flap after partial maxillectomy in the aspect of Quality of life outcomes.
Read the detailed description
The maxillary defects created by surgical removal of tumors result in communication between the oral and nasal cavities that in turn impair speech, swallowing, mastication, and facial esthetics, all of which consequently affect social behavior and quality of life (QoL). Consequently, the QoL need to be evaluated in patients with head and neck cancer because surgical resections and associated problems can affect QoL in significant ways.
University of Washington Head and Neck questionnaire is one of the measuring tools of the Quality of life, this UW-QOL questionnaire tests 12 domains relating to the patient with head and neck cancer. The sum score is calculated by adding together the scores for the 12 domains and dividing by 12 for a score from 0 (for poor health) to 100 (good health).
The maxillary defects reconstruction could be approached with prosthetic obturators rehabilitation or through surgical correction.
The obturator prostheses have many advantages that include; the easy visualization of the defect site, which allows for the detection of cancer recurrence; a reduction in the hospitalization period and costs; the ability to avoid a second operation; and the immediate re-establishment of facial morphology and oral functioning.However, several disadvantages to the maxillary obturator exist, including the discomfort of wearing a prosthesis, the inconvenience of removing and cleaning the prosthesis, the inability to successfully retain a prosthesis when the defect is large or when dentition is lacking, and the frequent need for readjustments by a prosthodontist.
The surgical intervention could be with various approaches that provide the reconstruction of communication and yields good results for the reconstruction of small defects.
The most commonly used surgical technique is the free tissue transfers that associated with increased hospital time and flap donor area morbidity. Nonetheless, Study conducted by Rogers et al., compared obturator prosthesis versus free flap surgical repair of the maxillary defect, the result revealed that there were no statistically significant differences were found between the two groups regarding quality of life measured with UW-QOL, although there was a tendency for obturator patients to indicate more problems with appearance. In this study, the obturator group recorded UW-QOL mean of 74±8.
The drawbacks of previous techniques have led to a search for alternate solutions, the use of a pedicle submental artery island flap is introduced as a new surgical option for head and neck tumor reconstruction. The advantages of this approach coming from its donor site can be performed in very thin section, pliability, and versatility in design. Moreover, the submental flap can be easily raised and involves shorter operative and hospital time compared to the free-flap procedure.
The pedicle submental artery island flap can be an excellent choice in patients with a high American Society of Anesthesiologists (ASA) risk score; moreover, this modality is effective in elderly patients, where the potential complications linked to microsurgical procedures are avoided.
There is no published study until now comparing pedicle submental artery island flap with prosthetic obturators. So that the aim of this study is to answer the following question "After partial maxillectomy in patients with a palatal defect, Does the submental artery flap offer different effect on the improvement of the quality of life when compared to maxillary obturator?"
- Being tested
- Submental flap for palatal reconstruction, maxillary obturator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submental flap for palatal reconstructionProcedure or surgery
Under General Anesthesia the tumor in the maxilla will be resected (partial maxillectomy) with a safety margin, then the defect will be reconstructed immediately by :
Submental artery flap : from submental area with 1 cm distance from inferior mandibular border in paddle shape.
- 1st step will be identify the facial artery and vein,
- 2nd step dissection and extend toward midline in subplatsmal plane. The flap contains submental artery and vein.
- 3rd step creating submucous tunnel between vestibular border of post maxillectomy defect and to extraoral incision .
The flap will be through the oral cavity and will be anchored to the intact remaining hard plate with bone sutures by 2-0 vicryl® suture.
maxillary obturatorDevice
immediate surgical obturator
| Study group | Role | What they receive |
|---|---|---|
| surgical reconstruction with submental flap | Experimental | surgical reconstruction with submental flap Receives: Procedure: Submental flap for palatal reconstruction |
| maxillary obturator | Active comparator | maxillary obturator Receives: Device: maxillary obturator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
measured by University of Washington Head and Neck questionnaire(UW-QOL).
Measured: one months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start30 Jan 2018 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion30 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient With Partial MaxillectomyStudies 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OMAR ALADASH, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03278041
- Sponsor's protocol ID
- 454
- Status last verified
- Sep 2017
- First submitted
- 7 Sep 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Submental Artery Island Flap Versus Maxillary Obturator Prosthesis on the Quality of Life in Patients With Palatal Defects. (Randomized Controlled Clinical Study)
- ClinicalTrials.gov ID
- NCT03278041
- Acronym / sponsor ID
- 454
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jan 2018 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 11 Sep 2017 (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 aim of the study is to compare maxillary obturator versus submental artery flap after partial maxillectomy in the aspect of Quality of life outcomes.
Detailed description
The maxillary defects created by surgical removal of tumors result in communication between the oral and nasal cavities that in turn impair speech, swallowing, mastication, and facial esthetics, all of which consequently affect social behavior and quality of life (QoL). Consequently, the QoL need to be evaluated in patients with head and neck cancer because surgical resections and associated problems can affect QoL in significant ways.
University of Washington Head and Neck questionnaire is one of the measuring tools of the Quality of life, this UW-QOL questionnaire tests 12 domains relating to the patient with head and neck cancer. The sum score is calculated by adding together the scores for the 12 domains and dividing by 12 for a score from 0 (for poor health) to 100 (good health).
The maxillary defects reconstruction could be approached with prosthetic obturators rehabilitation or through surgical correction.
The obturator prostheses have many advantages that include; the easy visualization of the defect site, which allows for the detection of cancer recurrence; a reduction in the hospitalization period and costs; the ability to avoid a second operation; and the immediate re-establishment of facial morphology and oral functioning.However, several disadvantages to the maxillary obturator exist, including the discomfort of wearing a prosthesis, the inconvenience of removing and cleaning the prosthesis, the inability to successfully retain a prosthesis when the defect is large or when dentition is lacking, and the frequent need for readjustments by a prosthodontist.
The surgical intervention could be with various approaches that provide the reconstruction of communication and yields good results for the reconstruction of small defects.
The most commonly used surgical technique is the free tissue transfers that associated with increased hospital time and flap donor area morbidity. Nonetheless, Study conducted by Rogers et al., compared obturator prosthesis versus free flap surgical repair of the maxillary defect, the result revealed that there were no statistically significant differences were found between the two groups regarding quality of life measured with UW-QOL, although there was a tendency for obturator patients to indicate more problems with appearance. In this study, the obturator group recorded UW-QOL mean of 74±8.
The drawbacks of previous techniques have led to a search for alternate solutions, the use of a pedicle submental artery island flap is introduced as a new surgical option for head and neck tumor reconstruction. The advantages of this approach coming from its donor site can be performed in very thin section, pliability, and versatility in design. Moreover, the submental flap can be easily raised and involves shorter operative and hospital time compared to the free-flap procedure.
The pedicle submental artery island flap can be an excellent choice in patients with a high American Society of Anesthesiologists (ASA) risk score; moreover, this modality is effective in elderly patients, where the potential complications linked to microsurgical procedures are avoided.
There is no published study until now comparing pedicle submental artery island flap with prosthetic obturators. So that the aim of this study is to answer the following question "After partial maxillectomy in patients with a palatal defect, Does the submental artery flap offer different effect on the improvement of the quality of life when compared to maxillary obturator?"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical reconstruction with submental flap | Experimental | Procedure: Submental flap for palatal reconstructionsurgical reconstruction with submental flap |
| maxillary obturator | Active comparator | Device: maxillary obturatormaxillary obturator |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients suffering from midface defects that involving palatal-maxillary bone are included.
- All ages and both sexes were included in this study.
- Patients with good general condition allowing major surgical procedure under general anesthesia.
- Be physically and psychologically able to tolerate procedures.
- Be cooperative to return for follow-up, examinations and evaluation.
Key exclusion criteria (4 listed)
- Patient who physically and psychologically not able to tolerate procedures. Because they cannot able to tolerate procedures and may discontinue the follow-up visits.
- Be Uncooperative to return for follow-up, examinations and evaluation.
- Patients with any systemic disease (e.g uncontrolled diabetic, bisphosphonates …..ect) because that may affect normal healing.
- Patient with bad oral hygiene.Because poor oral hygiene can cause inflammation which induces pain that effect outcome reading.
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 |
|---|---|---|
| Submental flap for palatal reconstructionUnder General Anesthesia the tumor in the maxilla will be resected (partial maxillectomy) with a safety margin, then the defect will be reconstructed immediately by : Submental artery flap : from submental area with 1 cm distance from inferior mandibular border in paddle shape. * 1st step will be identify the facial artery and vein, * 2nd step dissection and extend toward midline in subplatsmal plane. The flap contains submental artery and vein. * 3rd step creating submucous tunnel between vestibular border of post maxillectomy defect and to extraoral incision . The flap will be through the oral cavity and will be anchored to the intact remaining hard plate with bone sutures by 2-0 vicryl® suture. | Procedure or surgery | surgical reconstruction with submental flap |
| maxillary obturatorimmediate surgical obturator | Device | maxillary obturator |
Primary outcome
Quality of life
Time frame: one months post operative
measured by University of Washington Head and Neck questionnaire(UW-QOL).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submental flap for palatal reconstruction and maxillary obturator in people with Patient With Partial Maxillectomy and Submental Island Flap, 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 6 inclusion and 4 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 11 Sep 2017. 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?
Contact omar Q Aladashi, Master (00201154639509, omraladashi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: one months post operative). 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 Sep 2017; AzTrials last refreshed its copy on 7 Nov 2026.