Cleft of Alveolar RidgePhase 1NCT03010345
The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft
A Phase 1 study testing Osmed self inflating tissue expanders and Iliac bone graft in people with Cleft of Alveolar Ridge, run by Cairo University at 1 site in Egypt.
Trial summary
patient receiving treatment using the osmed expander will have enough soft tissue coverage securing the bone graft which will be placed in a later stage to close the alveolar cleft. Read more about this study
- Who is it for?
- Ages 7 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft of Alveolar Ridge
- What is being tested?
- Osmed self inflating tissue expanders and Iliac bone graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2016to Dec 2017
- Phase
- Phase 1
- 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 7 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Medically free patients.
- Patients suffering from alveolar cleft with anterior fistulas.
- Age Between 7 and 13 Years
- Both sexes.
- Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene.
- Highly motivated patients.
Who cannot join
- non motivated patients
Trial locations and contacts
1 site in 1 country.
About this study
patient receiving treatment using the osmed expander will have enough soft tissue coverage securing the bone graft which will be placed in a later stage to close the alveolar cleft.
Read the detailed description
to prove that the group treated with osmed expanders will suffer no soft tissue dehiscence and will have a higher volume of soft tissue at the stage of bone grafting.
- Conditions
- Cleft of Alveolar Ridge
- Being tested
- Osmed self inflating tissue expanders, Iliac bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osmed self inflating tissue expandersDevice
Osmed self inflating tissue expanders will be placed 21 days before bone grafting the cleft to gain soft tissue coverage
Iliac bone graftOther
Bone grafting the cleft without the use of osmed self inflating tissue expander
| Study group | Role | What they receive |
|---|---|---|
| Osmed self inflating tissue expanders | Experimental | All patients will undergo a two-stage procedure ,second stage under General endotracheal anesthesia. The first stage will be placement of the expanders. The second stage will be 21 days later, with removal of the expanders, palatal revision, and closure of the oronasal fistula Receives: Device: Osmed self inflating tissue expanders |
| Iliac bone graft | Experimental | Placement of bone graft without the use of self inflating expanders Receives: Other: Iliac bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No)
Measured: 21 days
Secondary outcomes (1)
Secondary Outcome : absence of soft tissue Dehiscence and preservation of bone graft volume , volume per cubic meter(Measured by cbct)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft of Alveolar RidgeStudies of the same condition, open and under way.
- More trials run by Cairo 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Hany shams, Cairo University
- Investigators
- Galal El Behiry, Phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03010345
- Sponsor's protocol ID
- Cairo university kasr el ainy
- Status last verified
- Jan 2017
- First submitted
- 27 Dec 2016
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Self Inflating Tissue Expanders In The Treatment Of Alveolar Cleft
- ClinicalTrials.gov ID
- NCT03010345
- Acronym / sponsor ID
- Cairo university kasr el ainy
- Conditions
- Cleft of Alveolar Ridge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 5 Jan 2017 (estimated)
- 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.
patient receiving treatment using the osmed expander will have enough soft tissue coverage securing the bone graft which will be placed in a later stage to close the alveolar cleft.
Detailed description
to prove that the group treated with osmed expanders will suffer no soft tissue dehiscence and will have a higher volume of soft tissue at the stage of bone grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osmed self inflating tissue expanders | Experimental | Device: Osmed self inflating tissue expandersAll patients will undergo a two-stage procedure ,second stage under General endotracheal anesthesia. The first stage will be placement of the expanders. The second stage will be 21 days later, with removal of the expanders, palatal revision, and closure of the oronasal fistula |
| Iliac bone graft | Experimental | Other: Iliac bone graftPlacement of bone graft without the use of self inflating expanders |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Medically free patients.
- Patients suffering from alveolar cleft with anterior fistulas.
- Age Between 7 and 13 Years
- Both sexes.
- Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene.
Key exclusion criteria (1 listed)
- non motivated patients
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 |
|---|---|---|
| Osmed self inflating tissue expandersOsmed self inflating tissue expanders will be placed 21 days before bone grafting the cleft to gain soft tissue coverage | Device | Osmed self inflating tissue expanders |
| Iliac bone graftBone grafting the cleft without the use of osmed self inflating tissue expander | Other | Iliac bone graft |
Primary outcome
Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No)
Time frame: 21 days
1 secondary outcome
Secondary Outcome : absence of soft tissue Dehiscence and preservation of bone graft volume , volume per cubic meter(Measured by cbct)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Cleft of Alveolar Ridge
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Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
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Assessment of Bone Volume Using Patient Specific Autogenous Bone Plug Versus Particulate Autogenous Bone for Unilateral Alveolar Ridge Reconstruction
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Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery
Orofacial Clefts, Cleft Lip and Palate
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Evaluation of Using Iliac Crest With and Without Platelet-Rich Fibrin in Repair of Congenital Alveolar Cleft
Alveolar Clefts, Alveolar Bone Grafting
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.
Galal El Behiry, Phd study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Osmed self inflating tissue expanders and Iliac bone graft in people with Cleft of Alveolar Ridge, run by Cairo 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 6 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: status not confirmed, as of the sponsor's last update on 5 Jan 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Primary Outcome : Absence of nasal regurgitation. Binary (Yes/No) (time frame: 21 days). 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 5 Jan 2017.