Cleft PalateNCT06856330
Effect of Furlow Palatoplasty With Buccal Myomucosal Flap on the Speech Development
An observational study of Cleft Palate, run by Fayoum University at 1 site in Egypt.
Trial summary
About 20 patient will be collected according to the eligibility criteria and grouped into Group I : 10 patients were treated with furlow with buccinators flap Group II : 10 patients were treated with 2 flap palatoplasty All patients will be examined by an expert Phoniatrician by Recording of speech samples in Arabic… Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Cleft Palate
- What is being tested?
- furlow with buccal myomucosal flap and two flap palatoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2025to 25 Jul 2025
- Phase
- Observational
- 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 3 to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: 3-5 year old children with treated cleft palate
Who may be able to join
- 3-5 years old childreen with previous treated complete cleft lip and palate, nonsyndromic.
- lip and palate repair performed by one craniofacial surgeon
Who cannot join
- Patients with syndromic cleft lip.
- Redu cases
- Bilateral cleft lip
- Patient older 5years or younger 3 years.
- Associated Cardiac anomalies.
- Any systemic condition
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
Fayoum University
Al Fayyum
shaimaa refahee, phd, 01227407987, smr11@fayoum.edu.eg
About this study
Official title: Efficacy of Two Flap Palatoplasty (TFP) Versus Furlow With Buccinator Flap (FPBF) During Primary Palatoplasty on the Speech Development
About 20 patient will be collected according to the eligibility criteria and grouped into Group I : 10 patients were treated with furlow with buccinators flap Group II : 10 patients were treated with 2 flap palatoplasty All patients will be examined by an expert Phoniatrician by Recording of speech samples in Arabic language for the children in a soundproof room including repeated syllables, sentences with high-pressure sounds and counting from 1 to 10. The records will be analyzed to assess the degree of hypernasality, speech intelligibility and compensatory speech errors
- Conditions
- Cleft Palate
- Being tested
- furlow with buccal myomucosal flap, two flap palatoplasty
- 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 with buccal myomucosal flapProcedure or surgery
patients were treated with furlow with buccal myomucosal flap
two flap palatoplastyProcedure or surgery
patients were treated with two flap palatoplasty
| Study group | Role | What they receive |
|---|---|---|
| two flap palatoplasty group | Not described Receives: Procedure: two flap palatoplasty | |
| furlow with buccal myomucosal flap group | Not described Receives: Procedure: furlow with buccal myomucosal flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasopharyngoscopic examination
this will be done through the nasopharyngoscopic examination of the cleft patients after repair with Furlow with buccinator flap versus two flap palatoplasty. it will assess the grade of velopharyngeal closure during speech
Measured: through study completion, an average one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start25 Mar 2025
- Primary completion1 Jun 2025
- Study completion25 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856330
- Sponsor's protocol ID
- 55
- Status last verified
- Jul 2025
- First submitted
- 22 Feb 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Refahee SM, Aboulhassan MA, Elrouby IM, Abd-El-Ghafour M. Speech outcome following primary furlow palatoplasty with buccal myomucosal flap versus two flap palatoplasty in patients with cleft palate. Clin Oral Investig. 2025 Dec 20;30(1):19. doi: 10.1007/s00784-025-06695-6.
PubMed 41420755
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Flap Palatoplasty (TFP) Versus Furlow With Buccinator Flap (FPBF) During Primary Palatoplasty on the Speech Development
- ClinicalTrials.gov ID
- NCT06856330
- Acronym / sponsor ID
- 55
- Conditions
- Cleft Palate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 25 Jul 2025 (estimated)
- First posted
- 4 Mar 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.
About 20 patient will be collected according to the eligibility criteria and grouped into Group I : 10 patients were treated with furlow with buccinators flap Group II : 10 patients were treated with 2 flap palatoplasty All patients will be examined by an expert Phoniatrician by Recording of speech samples in Arabic language for the children in a soundproof room including repeated syllables, sentences with high-pressure sounds and counting from 1 to 10. The records will be analyzed to assess the degree of hypernasality, speech intelligibility and compensatory speech errors
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| two flap palatoplasty group | – | Procedure: two flap palatoplasty |
| furlow with buccal myomucosal flap group | – | Procedure: furlow with buccal myomucosal flap |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 3-5 year old children with treated cleft palate
Key inclusion criteria (2 listed)
- 3-5 years old childreen with previous treated complete cleft lip and palate, nonsyndromic.
- lip and palate repair performed by one craniofacial surgeon
Key exclusion criteria (6 listed)
- Patients with syndromic cleft lip.
- Redu cases
- Bilateral cleft lip
- Patient older 5years or younger 3 years.
- Associated Cardiac anomalies.
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 with buccal myomucosal flappatients were treated with furlow with buccal myomucosal flap | Procedure or surgery | furlow with buccal myomucosal flap group |
| two flap palatoplastypatients were treated with two flap palatoplasty | Procedure or surgery | two flap palatoplasty group |
Primary outcome
nasopharyngoscopic examination
Time frame: through study completion, an average one week
this will be done through the nasopharyngoscopic examination of the cleft patients after repair with Furlow with buccinator flap versus two flap palatoplasty. it will assess the grade of velopharyngeal closure during speech
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 28 Jul 2025.
- Derived from this study: PubMed 41420755Refahee SM, Aboulhassan MA, Elrouby IM, Abd-El-Ghafour M. Speech outcome following primary furlow palatoplasty with buccal myomucosal flap versus two flap palatoplasty in patients with cleft palate. Clin Oral Investig. 2025 Dec 20;30(1):19. doi: 10.1007/s00784-025-06695-6.
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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?
An observational study of Cleft Palate, run by Fayoum 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 2 inclusion and 6 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 28 Jul 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?
Contact Shaimaa Refahee (01227407987, smr11@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nasopharyngoscopic examination (time frame: through study completion, an average one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06856330, which also lists 1 linked publication.
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 28 Jul 2025.