Cleft PalateNCT05405738
Cleft Palate Technique and Maxillary Growth
An observational study of Cleft Palate and Growth, run by Fayoum University at 1 site in Egypt.
Trial summary
comparison of the maxillary growth between cleft palate patients that underwent to repair by 2 flap palatoplasty versus Furlow with buccinator technique Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Cleft Palate, Growth
- What is being tested?
- 2 flap palatoplasty technique, normal group and Furlow with buccinator technique
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 6 May 2022to 1 Mar 2023
- Phase
- Observational
- 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 5 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: 5-6ys old child with treated cleft palate
Who may be able to join
- 5-6 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 6years or younger 5 years.
- Associated Cardiac anomalies.
- Any systemic condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of 2 Flap Palatoplasty Versus Furlow With Buccinators Flap During Palatal Cleft Repair on the Maxillary Development Patterns in Comparison to Non-cleft Children at 5-6years of Age
comparison of the maxillary growth between cleft palate patients that underwent to repair by 2 flap palatoplasty versus Furlow with buccinator technique
- Conditions
- Cleft Palate, Growth
- Being tested
- 2 flap palatoplasty technique, normal group, Furlow with buccinator technique
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 flap palatoplasty techniqueProcedure or surgery
cleft palate repair by 2 flap palatoplasty technique
normal groupOther
control normal group
Furlow with buccinator techniqueProcedure or surgery
cleft palate repair by Furlow with buccinator technique
| Study group | Role | What they receive |
|---|---|---|
| normal group | Not described Receives: Other: normal group | |
| 2flap palatoplasty group | Not described Receives: Procedure: 2 flap palatoplasty technique | |
| Furlow with buccinator group | Not described Receives: Procedure: Furlow with buccinator technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
maxillar growth
evaluation of the maxillary growth through Inter-canine width (ICW) measurement by mm
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 posted6 Jun 2022
- Study start6 May 2022
- Primary completion28 Feb 2023
- Study completion1 Mar 2023
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.
- 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
- 28 participants (actual)
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
- NCT05405738
- Sponsor's protocol ID
- 2
- Status last verified
- Sep 2023
- First submitted
- 22 May 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aboulhassan MA, Refahee SM, Sabry S, Abd-El-Ghafour M. Effects of two flap palatoplasty versus furlow palatoplasty with buccal myomucosal flap on maxillary arch dimensions in patients with cleft palate at the primary dentition stage: a cohort study. Clin Oral Investig. 2023 Sep;27(9):5605-5613. doi: 10.1007/s00784-023-05182-0. Epub 2023 Aug 2.
PubMed 37530892
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 2 Flap Palatoplasty Versus Furlow With Buccinators Flap During Palatal Cleft Repair on the Maxillary Development Patterns in Comparison to Non-cleft Children at 5-6years of Age
- ClinicalTrials.gov ID
- NCT05405738
- Acronym / sponsor ID
- 2
- Conditions
- Cleft Palate, Growth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 6 Jun 2022 (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.
comparison of the maxillary growth between cleft palate patients that underwent to repair by 2 flap palatoplasty versus Furlow with buccinator technique
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal group | – | Other: normal group |
| 2flap palatoplasty group | – | Procedure: 2 flap palatoplasty technique |
| Furlow with buccinator group | – | Procedure: Furlow with buccinator technique |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 5-6ys old child with treated cleft palate
Key inclusion criteria (2 listed)
- 5-6 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 6years or younger 5 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 |
|---|---|---|
| 2 flap palatoplasty techniquecleft palate repair by 2 flap palatoplasty technique | Procedure or surgery | 2flap palatoplasty group |
| normal groupcontrol normal group | Other | normal group |
| Furlow with buccinator techniquecleft palate repair by Furlow with buccinator technique | Procedure or surgery | Furlow with buccinator group |
Primary outcome
maxillar growth
Time frame: through study completion, an average one week
evaluation of the maxillary growth through Inter-canine width (ICW) measurement by mm
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 28 Sep 2023.
- Derived from this study: PubMed 37530892Aboulhassan MA, Refahee SM, Sabry S, Abd-El-Ghafour M. Effects of two flap palatoplasty versus furlow palatoplasty with buccal myomucosal flap on maxillary arch dimensions in patients with cleft palate at the primary dentition stage: a cohort study. Clin Oral Investig. 2023 Sep;27(9):5605-5613. doi: 10.1007/s00784-023-05182-0. Epub 2023 Aug 2.
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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?
An observational study of Cleft Palate and Growth, 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: finished, as of the sponsor's last update on 28 Sep 2023. 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?
maxillar growth (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 NCT05405738, 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 Sep 2023.