Horizontal Ridge DeficiencyVIP-CTNCT05813340
Vascularized Inter-positional Periosteal Connective-tissue Flap Versus Collagen Membrane in Guided Bone Regeneration
A study testing Vascularized inter-positional periosteal connective tissue flap in people with Horizontal Ridge Deficiency, run by Cairo University at 1 site in Egypt.
Trial summary
this study compares 2 techniques in guided bone regeneration for horizontal ridge augmentation in aesthetic zone Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Horizontal Ridge Deficiency
- What is being tested?
- Vascularized inter-positional periosteal connective tissue flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Dec 2023
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with a horizontal defect in anterior and premolar areas of the maxilla (aesthetic zone).
Who cannot join
- poor oral hygiene
- radiation therapy of head and neck cancer
- intraoral soft and hard tissue lesions
- Heavy smoking
- Bone pathology
Trial locations and contacts
1 site in 1 country.
Rofaida Atef, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry Cairo university
Cairo, 12311
Faculty of Dentistry, 0223646375
About this study
Official title: Vascularized Inter-positional Periosteal Connective-tissue Flap Versus Collagen Membrane in Guided Bone Regeneration in Horizontal Ridge Augmentation in Aesthetic Zone
this study compares 2 techniques in guided bone regeneration for horizontal ridge augmentation in aesthetic zone
Read the detailed description
Guided bone regeneration is a technique for ridge augmentation using membranes The membrane of GBR is an essential component of treatment as it has some important characteristics manageability, space-making ability, and adequate mechanical, physical properties, and biocompatibility Collagen membranes are the most commonly used and can inhibit soft tissue growth in bone defects and achieve better wound healing and bone regeneration.
on the other hand, a Vascularized inter-positional periosteal connective tissue flap is a flap that has been used as a substitute for the collagen membrane with promising results. Vascularized inter-positional periosteal connective tissue flap (VIPCTF) may have many advantages over traditional collagen membranes such as; high vascularity, decreased cost (as it may substitute membrane), providing an increase in soft tissue thickness, and reusability.
So Evaluation of effect of vascularized interpositional periosteal connective tissue flap on horizontal ridge augmentation grafting of the anterior maxilla in comaprison with the collagen membranes
- Conditions
- Horizontal Ridge Deficiency
- Being tested
- Vascularized inter-positional periosteal connective tissue flap
- Keywords
- VIPCTF, GBR, Horizontal ridge augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascularized inter-positional periosteal connective tissue flapProcedure or surgery
It is a vascularized pedicled flap derived from the hard palate that can be used as a barrier to prevent in growth of soft tissue in guided bone regeneration and to increase soft tissue quantity
| Study group | Role | What they receive |
|---|---|---|
| vascularized interpositional periosteal connective tissue flap | Experimental | Vascularized inter-positional periosteal connective tissue flap (VIPCTF) may have many advantages over traditional collagen membranes such as; high vascularity, decreased cost (as it may substitute membrane), providing an increase in soft tissue thickness, and reusability. Receives: Procedure: Vascularized inter-positional periosteal connective tissue flap |
| collagen membrane | Active comparator | Collagen membranes are the most commonly used and can inhibit soft tissue growth in bone defects, They achieve better wound healing and bone regeneration. Receives: Procedure: Vascularized inter-positional periosteal connective tissue flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of bone width gain (horizontal augmentation)
bone width gain is measured in millimeters by Cone beam computed tomography
Measured: 6 months
Secondary outcomes (1)
Percentage of bone formation in the bone biopsy
Area percentage of newly formed bone is measured through histomorphometric analysis
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 posted14 Apr 2023
- Study start1 Jan 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (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 Horizontal Ridge DeficiencyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Abdel Hady Ismail, Cairo University
- Investigators
- Esraa Ismail, Maters, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813340
- Sponsor's protocol ID
- 111111
- Acronym
- VIP-CT
- Status last verified
- Apr 2023
- First submitted
- 2 Apr 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khajehahmadi, S., & Rahpeyma, A. (2014). Vascularized interpositional periosteal connective tissue flap in implant dentistry. Journal of Dental Implants, 4(1), 29. https://doi.org/10.4103/0974-6781.130952
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascularized Inter-positional Periosteal Connective-tissue Flap Versus Collagen Membrane in Guided Bone Regeneration in Horizontal Ridge Augmentation in Aesthetic Zone
- ClinicalTrials.gov ID
- NCT05813340
- Acronym / sponsor ID
- VIP-CT / 111111
- Conditions
- Horizontal Ridge Deficiency
- Keywords
- VIPCTF, GBR, Horizontal ridge augmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 14 Apr 2023 (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.
this study compares 2 techniques in guided bone regeneration for horizontal ridge augmentation in aesthetic zone
Detailed description
Guided bone regeneration is a technique for ridge augmentation using membranes The membrane of GBR is an essential component of treatment as it has some important characteristics manageability, space-making ability, and adequate mechanical, physical properties, and biocompatibility Collagen membranes are the most commonly used and can inhibit soft tissue growth in bone defects and achieve better wound healing and bone regeneration.
on the other hand, a Vascularized inter-positional periosteal connective tissue flap is a flap that has been used as a substitute for the collagen membrane with promising results. Vascularized inter-positional periosteal connective tissue flap (VIPCTF) may have many advantages over traditional collagen membranes such as; high vascularity, decreased cost (as it may substitute membrane), providing an increase in soft tissue thickness, and reusability.
So Evaluation of effect of vascularized interpositional periosteal connective tissue flap on horizontal ridge augmentation grafting of the anterior maxilla in comaprison with the collagen membranes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vascularized interpositional periosteal connective tissue flap | Experimental | Procedure: Vascularized inter-positional periosteal connective tissue flapVascularized inter-positional periosteal connective tissue flap (VIPCTF) may have many advantages over traditional collagen membranes such as; high vascularity, decreased cost (as it may substitute membrane), providing an increase in soft tissue thickness, and reusability. |
| collagen membrane | Active comparator | Procedure: Vascularized inter-positional periosteal connective tissue flapCollagen membranes are the most commonly used and can inhibit soft tissue growth in bone defects, They achieve better wound healing and bone regeneration. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with a horizontal defect in anterior and premolar areas of the maxilla (aesthetic zone).
Key exclusion criteria (5 listed)
- poor oral hygiene
- radiation therapy of head and neck cancer
- intraoral soft and hard tissue lesions
- Heavy smoking
- Bone pathology
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 |
|---|---|---|
| Vascularized inter-positional periosteal connective tissue flapIt is a vascularized pedicled flap derived from the hard palate that can be used as a barrier to prevent in growth of soft tissue in guided bone regeneration and to increase soft tissue quantity | Procedure or surgery | collagen membrane, vascularized interpositional periosteal connective tissue flap |
Primary outcome
Amount of bone width gain (horizontal augmentation)
Time frame: 6 months
bone width gain is measured in millimeters by Cone beam computed tomography
1 secondary outcome
Percentage of bone formation in the bone biopsy
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 14 Apr 2023.
- BackgroundKhajehahmadi, S., & Rahpeyma, A. (2014). Vascularized interpositional periosteal connective tissue flap in implant dentistry. Journal of Dental Implants, 4(1), 29. https://doi.org/10.4103/0974-6781.130952
- Individual participant dataSharing planned: No
Related trials for Horizontal Ridge Deficiency
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Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
Horizontal Alveolar Ridge Deficiency
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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Shell Technique for Implant Site Development
Ridge Augmentation, Ridge Deficiency
Recruiting
Histological and Histomorphometric Assessment With Inflammatory Profile Analysis of Bone Tissue After Horizontal Ridge Augmentation Using Customized Porous Zirconia Shell
Alveolar Bone Loss, Alveolar Ridge Deficiency
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.
Rofaida Atef, PhD contact
Esraa Ismail, Maters principal investigator
Cairo 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 Vascularized inter-positional periosteal connective tissue flap in people with Horizontal Ridge Deficiency, 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 1 inclusion and 5 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 14 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Ismail, Masters (01155400246 ext. +2, esera.hady@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of bone width gain (horizontal augmentation) (time frame: 6 months). 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 NCT05813340, 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 14 Apr 2023.