Cleft Palate, Unilateral, CompleteNCT04346173
Palatal Lengthening Using Buccinator Myomucosal Flaps with Furlow Z-plasty Technique for Primary Cleft Palate Repair
A study testing furlow z plasty with buccinator myomucosal flap in people with Cleft Palate, Unilateral, Complete, run by Mahmoud Akram at 1 site in Egypt.
Trial summary
: Cleft palate is a congenital deformity caused by abnormal facial development during intra-uterine life. Worldwide, the prevalence of cleft lip/palate is about 1:1000 live births. Read more about this study
- Who is it for?
- Ages 9 to 18 months
- Conditions the study is for
- Cleft Palate, Unilateral, Complete
- What is being tested?
- furlow z plasty with buccinator myomucosal flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 Mar 2020
- 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 9 to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients in the age frame between 9 months and 18 months.
- Cleft palate alone or cleft lip and palate patients.
- Patients who have not done any previous palatal repair
- Haemoglobin level above 10 grams.
- Weight above 10 pounds.
Who cannot join
- Syndromic patients.
- Medically compromised patients contradicting operation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Palatal Lengthening Using Buccinator Myomucosal Flaps with Furlow Z-plasty Technique for Primary Cleft Palate Repair (A Clinical Study)
: Cleft palate is a congenital deformity caused by abnormal facial development during intra-uterine life. Worldwide, the prevalence of cleft lip/palate is about 1:1000 live births.
The levator vela palatini muscles are malpositioned sagittally, running postero-anteriorly and inserted onto the posterior edge of the hard palate in cleft palate patients . This configuration prevents the muscle from exerting its upward, backward, and lateral pull.
Read more
Various modalities have been described with major refinements over the past 30 years. Gradually, cleft surgeons began to appreciate the importance of dissection and retro-positioning of the levator muscle on improving speech outcomes.
Furlow was the first to describe the palatoplasty technique, in which the levator muscle is dissected and freely released from its abnormal position and retro-positioned in a Z-plasty lengthening technique without dissection on the hard palate. However , among the problems that have been raised concerning the Furlow palatoplasty is the limitation of the procedure in wide clefts. Furthermore, the possibility of higher fistula rate associated with the technique.
These considerations have led to modified palatal lengthening by buccinator myomucosal flaps which is this study working on.
- Conditions
- Cleft Palate, Unilateral, Complete
- Being tested
- furlow z plasty with buccinator myomucosal flap
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
furlow z plasty with buccinator myomucosal flapProcedure or surgery
using furlow palatoplasty technique accompanied with addition of buccinator myomucosal flap for closure of primary unilateral cleft palate
| Study group | Role | What they receive |
|---|---|---|
| furlow z plasty with buccinator myomucosal flap | Experimental | using furlow palatoplasty technique accompanied with addition of buccinator myomucosal flap for closure of primary unilateral cleft palate Receives: Procedure: furlow z plasty with buccinator myomucosal flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
palatal lengthening
measuring the length the palate will gain using this technique
Measured: immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Jul 2018
- Primary completion1 Jan 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Palate, Unilateral, CompleteStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud Akram
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Akram, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346173
- Sponsor's protocol ID
- Furlow with buccinator
- Status last verified
- Apr 2020
- First submitted
- 11 Apr 2020
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palatal Lengthening Using Buccinator Myomucosal Flaps with Furlow Z-plasty Technique for Primary Cleft Palate Repair (A Clinical Study)
- ClinicalTrials.gov ID
- NCT04346173
- Acronym / sponsor ID
- Furlow with buccinator
- Conditions
- Cleft Palate, Unilateral, Complete
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mahmoud AkramUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 15 Apr 2020 (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.
: Cleft palate is a congenital deformity caused by abnormal facial development during intra-uterine life. Worldwide, the prevalence of cleft lip/palate is about 1:1000 live births.
The levator vela palatini muscles are malpositioned sagittally, running postero-anteriorly and inserted onto the posterior edge of the hard palate in cleft palate patients . This configuration prevents the muscle from exerting its upward, backward, and lateral pull.
Various modalities have been described with major refinements over the past 30 years. Gradually, cleft surgeons began to appreciate the importance of dissection and retro-positioning of the levator muscle on improving speech outcomes.
Furlow was the first to describe the palatoplasty technique, in which the levator muscle is dissected and freely released from its abnormal position and retro-positioned in a Z-plasty lengthening technique without dissection on the hard palate. However , among the problems that have been raised concerning the Furlow palatoplasty is the limitation of the procedure in wide clefts. Furthermore, the possibility of higher fistula rate associated with the technique.
These considerations have led to modified palatal lengthening by buccinator myomucosal flaps which is this study working on.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| furlow z plasty with buccinator myomucosal flap | Experimental | Procedure: furlow z plasty with buccinator myomucosal flapusing furlow palatoplasty technique accompanied with addition of buccinator myomucosal flap for closure of primary unilateral cleft palate |
Who may qualify
- Ages
- 9 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Patients in the age frame between 9 months and 18 months.
- Cleft palate alone or cleft lip and palate patients.
- Patients who have not done any previous palatal repair
- Haemoglobin level above 10 grams.
- Weight above 10 pounds.
Key exclusion criteria (2 listed)
- Syndromic patients.
- Medically compromised patients contradicting operation.
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 |
|---|---|---|
| furlow z plasty with buccinator myomucosal flapusing furlow palatoplasty technique accompanied with addition of buccinator myomucosal flap for closure of primary unilateral cleft palate | Procedure or surgery | furlow z plasty with buccinator myomucosal flap |
Primary outcome
palatal lengthening
Time frame: immediately postoperative
measuring the length the palate will gain using this technique
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 26 Oct 2024.
- Individual participant dataSharing planned: No
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MRI Assessment of Velopharyngeal Anatomy After Modified Furlow-Buccinator Flap in Late Primary Palate Repair
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing furlow z plasty with buccinator myomucosal flap in people with Cleft Palate, Unilateral, Complete, run by Mahmoud Akram 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 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 26 Oct 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?
palatal lengthening (time frame: immediately postoperative). 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 26 Oct 2024.