Alveolar CleftNCT06294522
Reconstruction of Nasal Floor for Three-dimensional Repair of Alveolar Cleft
A study testing reconstruction of alveolar cleft in people with Alveolar Cleft, run by Tanta University at 1 site in Egypt.
Trial summary
reconstruction of alveolar cleft with autogenous bone after elevation of mucoperiosteal flap and suturing of nasal floor and palatal flap Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Cleft
- What is being tested?
- reconstruction of alveolar cleft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2023to 16 Feb 2024
- 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 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients had alveolar cleft adequate and healthy soft tissue
- -
Who cannot join
- age less than 9 very wide cleft scared soft tissue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lecturer of Oral and Maxillofacial Surgery
reconstruction of alveolar cleft with autogenous bone after elevation of mucoperiosteal flap and suturing of nasal floor and palatal flap
Read the detailed description
gingival mucoperiosteal flaps are designed along the cleft margins and elevated medial and lateral mucoperiosteal flaps are generated from the cleft and the gingival sulcus of the teeth. To obtain adequate mobility of the posterior flap, the flap must be extended to the first or the second molar and back-cut up to the buccal sulcus while taking care not to injure the alveolar bone covering the roots of the teeth. These flaps are raised up to and around the piriform aperture, and then are separated from the nasal mucosa the palatal mucoperiosteal flaps along the cleft margins are then elevated from the palate. After complete exposure of all the bony clefts, the nasal lining of the nostril floor is approximated and sutured, and the palatal flaps are then turned back and sutured to make a soft-tissue pocket. Grafting of the defect is accomplished with cortical bone only from the chin the cortical shelf is prepared to be two layers perpendicular to each other the first one is parallel to the nasal floor and second one is continuous with buccal cortex of alveolar ridge then cancellous bone will be packed under these shelves and be compressed into the cleft defect to maximize the number of osteo-competent cells and the osteoid material per unit graft volume. When packing bone particles, it is better to create the maxilla and alveolar ridges and elevate the depressed nostril by appropriately supporting the nasal base and aligning the symmetry. The rest can then be covered with gingival mucoperiosteal flaps through tension-free transposition
- Conditions
- Alveolar Cleft
- Being tested
- reconstruction of alveolar cleft
- Keywords
- alveolar cleft, nasal floor support, autogenous bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reconstruction of alveolar cleftProcedure or surgery
after elevation of mucoperiosteal flap related to cleft side. suturing of nasal floor and palatal tissue. harvesting of autogenous graft and reconstruction of nasal floor and labial plate of cleft then suturing of flap labially without tension
| Study group | Role | What they receive |
|---|---|---|
| reconstruction of alveolar cleft | Experimental | gingival mucoperiosteal flaps are designed along the cleft margins and elevated. These flaps are raised up and then are separated from the nasal mucosa the palatal mucoperiosteal flaps along the cleft margins are then elevated from the palate. After complete exposure of all the bony clefts, the nasal lining of the nostril floor is approximated and sutured, and the palatal flaps are then turned back and sutured to make a soft-tissue pocket. Grafting of the defect is accomplished with cortical bone only from the chin the cortical shelf is prepared to be two layers perpendicular to each other the first one is parallel to the nasal floor and second one is continuous with buccal cortex of alveolar ridge then cancellous bone will be packed under these shelves and be compressed into the cleft defects. Receives: Procedure: reconstruction of alveolar cleft |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of oronasal fistula
using valsalva test
Measured: one month
volume of alveolar cleft after reconstruction
using cone beam ct (cbct) to measure volumetric changes
Measured: immediate and after 6 months
density of bone
using cbct with housenfield units D1 (>1250), D2(850-1250),D3(350-850),D4(150-350)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start20 Jul 2023
- Primary completion6 Jan 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar CleftStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mona samy sheta, Tanta University
- Investigators
- mona s sheta, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294522
- Sponsor's protocol ID
- 1984
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lecturer of Oral and Maxillofacial Surgery
- ClinicalTrials.gov ID
- NCT06294522
- Acronym / sponsor ID
- 1984
- Conditions
- Alveolar Cleft
- Keywords
- alveolar cleft, nasal floor support, autogenous bone graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 6 Jan 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 5 Mar 2024 (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.
reconstruction of alveolar cleft with autogenous bone after elevation of mucoperiosteal flap and suturing of nasal floor and palatal flap
Detailed description
gingival mucoperiosteal flaps are designed along the cleft margins and elevated medial and lateral mucoperiosteal flaps are generated from the cleft and the gingival sulcus of the teeth. To obtain adequate mobility of the posterior flap, the flap must be extended to the first or the second molar and back-cut up to the buccal sulcus while taking care not to injure the alveolar bone covering the roots of the teeth. These flaps are raised up to and around the piriform aperture, and then are separated from the nasal mucosa the palatal mucoperiosteal flaps along the cleft margins are then elevated from the palate. After complete exposure of all the bony clefts, the nasal lining of the nostril floor is approximated and sutured, and the palatal flaps are then turned back and sutured to make a soft-tissue pocket. Grafting of the defect is accomplished with cortical bone only from the chin the cortical shelf is prepared to be two layers perpendicular to each other the first one is parallel to the nasal floor and second one is continuous with buccal cortex of alveolar ridge then cancellous bone will be packed under these shelves and be compressed into the cleft defect to maximize the number of osteo-competent cells and the osteoid material per unit graft volume. When packing bone particles, it is better to create the maxilla and alveolar ridges and elevate the depressed nostril by appropriately supporting the nasal base and aligning the symmetry. The rest can then be covered with gingival mucoperiosteal flaps through tension-free transposition
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| reconstruction of alveolar cleft | Experimental | Procedure: reconstruction of alveolar cleftgingival mucoperiosteal flaps are designed along the cleft margins and elevated. These flaps are raised up and then are separated from the nasal mucosa the palatal mucoperiosteal flaps along the cleft margins are then elevated from the palate. After complete exposure of all the bony clefts, the nasal lining of the nostril floor is approximated and sutured, and the palatal flaps are then turned back and sutured to make a soft-tissue pocket. Grafting of the defect is accomplished with cortical bone only from the chin the cortical shelf is prepared to be two layers perpendicular to each other the first one is parallel to the nasal floor and second one is continuous with buccal cortex of alveolar ridge then cancellous bone will be packed under these shelves and be compressed into the cleft defects. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients had alveolar cleft adequate and healthy soft tissue
- -
Key exclusion criteria (1 listed)
- age less than 9 very wide cleft scared soft tissue
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 |
|---|---|---|
| reconstruction of alveolar cleftafter elevation of mucoperiosteal flap related to cleft side. suturing of nasal floor and palatal tissue. harvesting of autogenous graft and reconstruction of nasal floor and labial plate of cleft then suturing of flap labially without tension | Procedure or surgery | reconstruction of alveolar cleft |
Primary outcome
recurrence of oronasal fistula
Time frame: one month
using valsalva test
volume of alveolar cleft after reconstruction
Time frame: immediate and after 6 months
using cone beam ct (cbct) to measure volumetric changes
density of bone
Time frame: Six months
using cbct with housenfield units D1 (>1250), D2(850-1250),D3(350-850),D4(150-350)
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 Mar 2024.
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Facial Artery Musculomucosal Flap and Bone Volume Gain in Alveolar Cleft 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.
mona s sheta principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reconstruction of alveolar cleft in people with Alveolar Cleft, run by Tanta 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 1 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 Mar 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?
recurrence of oronasal fistula (time frame: one month). The study lists 3 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 Mar 2024.