Cleft PalateNCT05196555
Cleft Palate With Intravelar Veloplasty Repair
A study testing Repair of cleft palate with intravelar veloplasty (IVVP) in people with Cleft Palate, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Cleft palate repair is the most important component of cleft surgery, not only in that it determines the outcome as far as speech and communication are concerned, but also in that it potentially has the greatest impact on maxillary growth and the dental arch relationship. Read more about this study
- Who is it for?
- Ages 9 months to 18 years
- Conditions the study is for
- Cleft Palate
- What is being tested?
- Repair of cleft palate with intravelar veloplasty (IVVP)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Aug 2019to 17 Dec 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 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with isolated cleft palate age from 9 months to 18 years.
- Patients with submucous cleft.
- Velopharyngeal incompetence (VPI) for palatal re-repair.
Who cannot join
- Medically unfit patients.
- Syndromic patients with cleft lip and palate.
- Patients with cleft palate associated with multiple congenital anomalies.
- Patients with neurological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microscopic Surgical Repair of Cleft Palate With Inravelar Veloplasty
Cleft palate repair is the most important component of cleft surgery, not only in that it determines the outcome as far as speech and communication are concerned, but also in that it potentially has the greatest impact on maxillary growth and the dental arch relationship. Sommerlad technique has been described as a more physiological approach, aiming to restore the anatomy of the velum. This technique, often described as radical intravelar veloplasty, has the following distinctive components: a radical retroposition of velar musculature (m. levator veli palatini, m. palatoglossus, and m. palatopharyngeus), combined with minimal dissection of the hard palate, a tensor tenotomy, and the repair of the m. levator sling
- Conditions
- Cleft Palate
- Being tested
- Repair of cleft palate with intravelar veloplasty (IVVP)
- Medical subject headings
- Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair of cleft palate with intravelar veloplasty (IVVP)Procedure or surgery
A triangular flap is designed comprising new epithelial tissue which will be turned over to help close the nasal mucosa. Using a single hook, the oral mucosa and gland layer is separated from the muscle layer. Dissection of the greater palatine nerve-vessel bundle. The anterior palatal flap is raised by a curved elevator. The closure of the nasal mucosa and muscle is completed. Dissection of Velo Palatine Levator begins from the posterior rim of muscle and 5 mm from the midline.
| Study group | Role | What they receive |
|---|---|---|
| microscopic surgical repair of cleft palate with intravelar veloplasty (IVVP) | Experimental | Not described Receives: Procedure: Repair of cleft palate with intravelar veloplasty (IVVP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in soft palate elevation
Observing the range of motion of soft palate using videofluoroscopy
Measured: Baseline, immediately after procedure
change in tongue motion assessment
Observing the range of tongue motion using videofluoroscopy
Measured: Baseline, immediately after procedure
change in lips motion assessment
Observing the range of lips motion using videofluoroscopy
Measured: Baseline, immediately after procedure
change in nasal airflow
Using Nasometer II model 6450 to assess the ratio of oral airflow to nasal airflow.
Measured: Baseline, immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start6 Aug 2019
- Primary completion17 Dec 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196555
- Sponsor's protocol ID
- Maxillo_2021
- Status last verified
- Jan 2022
- First submitted
- 17 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microscopic Surgical Repair of Cleft Palate With Inravelar Veloplasty
- ClinicalTrials.gov ID
- NCT05196555
- Acronym / sponsor ID
- Maxillo_2021
- Conditions
- Cleft Palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 19 Jan 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.
Cleft palate repair is the most important component of cleft surgery, not only in that it determines the outcome as far as speech and communication are concerned, but also in that it potentially has the greatest impact on maxillary growth and the dental arch relationship. Sommerlad technique has been described as a more physiological approach, aiming to restore the anatomy of the velum. This technique, often described as radical intravelar veloplasty, has the following distinctive components: a radical retroposition of velar musculature (m. levator veli palatini, m. palatoglossus, and m. palatopharyngeus), combined with minimal dissection of the hard palate, a tensor tenotomy, and the repair of the m. levator sling
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| microscopic surgical repair of cleft palate with intravelar veloplasty (IVVP) | Experimental | Procedure: Repair of cleft palate with intravelar veloplasty (IVVP) |
Who may qualify
- Ages
- 9 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with isolated cleft palate age from 9 months to 18 years.
- Patients with submucous cleft.
- Velopharyngeal incompetence (VPI) for palatal re-repair.
Key exclusion criteria (4 listed)
- Medically unfit patients.
- Syndromic patients with cleft lip and palate.
- Patients with cleft palate associated with multiple congenital anomalies.
- Patients with neurological disorders.
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 |
|---|---|---|
| Repair of cleft palate with intravelar veloplasty (IVVP)A triangular flap is designed comprising new epithelial tissue which will be turned over to help close the nasal mucosa. Using a single hook, the oral mucosa and gland layer is separated from the muscle layer. Dissection of the greater palatine nerve-vessel bundle. The anterior palatal flap is raised by a curved elevator. The closure of the nasal mucosa and muscle is completed. Dissection of Velo Palatine Levator begins from the posterior rim of muscle and 5 mm from the midline. | Procedure or surgery | microscopic surgical repair of cleft palate with intravelar veloplasty (IVVP) |
Primary outcome
change in soft palate elevation
Time frame: Baseline, immediately after procedure
Observing the range of motion of soft palate using videofluoroscopy
change in tongue motion assessment
Time frame: Baseline, immediately after procedure
Observing the range of tongue motion using videofluoroscopy
change in lips motion assessment
Time frame: Baseline, immediately after procedure
Observing the range of lips motion using videofluoroscopy
change in nasal airflow
Time frame: Baseline, immediately after procedure
Using Nasometer II model 6450 to assess the ratio of oral airflow to nasal airflow.
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 19 Jan 2022.
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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 Repair of cleft palate with intravelar veloplasty (IVVP) in people with Cleft Palate, run by Hams Hamed Abdelrahman 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 3 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: finished, as of the sponsor's last update on 19 Jan 2022. 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?
change in soft palate elevation (time frame: Baseline, immediately after procedure). The study lists 4 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 19 Jan 2022.