Alveolar Bone GraftingperiosteumNCT06795919
Use of Particulate Cortico- Cancellous Anterior Iliac Graft with Periosteum Membrane in Unilateral Alveolar Cleft Grafting Versus Particulate Cortico-cancellous Anterior Iliac Grafting Alone.
A study testing : delayed surgical repair of alveolar cleft using particulate cortico-cancellous anterior iliac bon in people with Alveolar Bone Grafting, run by Nesma Mattar at 1 site in Egypt.
Trial summary
In the past few years, periosteal membrane has been used in orthopedic surgery as well as periodontal surgery as a mechanism to promote bone healing without the ingrowth of fibrous tissues. It has shown its efficiency in maintaining the bone volume and density in postoperative follow up. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Grafting
- What is being tested?
- : delayed surgical repair of alveolar cleft using particulate cortico-cancellous anterior iliac bon
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 9 -12 years, depending on dental age not chronological.
- systemically healthy patients (American Society of Anesthesiologists -ASA I and II)
- Patients secondary alveolar cleft patient.
Who cannot join
- Patients with recurrent palatal fistula.
- Existence of syndromic cleft palate.
- Patient with uncontrolled systematic disease.
- Patients undergoing radiotherapy or chemotherapy for malignancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nesma Mo Ibrahim, Lecturer Assistant of OMFS contact
Egypt1 site
School of Dentistry, Cairo.
Cairo, Giza Governorate, 12345
Wael Wael M Abd El-Samea, Secretariat of Oral surgery, 00201006344582, waelmohamed@dentistry.cu.edu.eg
m2shindy@hotmail.com
About this study
Official title: Use of Particulate Cortico- Cancellous Anterior Iliac Graft with Periosteal Membrane in Treatment of Unilateral Alveolar Cleft Grafting Versus Particulate Cortico-cancellous Anterior Iliac Grafting Alone a Randomized Clinical Trial
In the past few years, periosteal membrane has been used in orthopedic surgery as well as periodontal surgery as a mechanism to promote bone healing without the ingrowth of fibrous tissues. It has shown its efficiency in maintaining the bone volume and density in postoperative follow up. This can in turn solve the problem of potential bone loss in patients of alveolar cleft.
The study aims to see if fixing the periosteum of the anterior ilium with tacks after bone graft application in the donor site will help maintain the graft and promote healing for the alveolar cleft patients
Read the detailed description
Cleft lip and palate are the most common congenital deformity affecting craniofacial structures. Delayed alveolar cleft defect presents a challenge for reconstruction to achieve functional and esthetic results. Many sources of bone graft have been shown in the literature: cortical or cancellous bone, iliac crest, cranial bone, mandibular symphysis, tibia, and rib. The main complication is graft loss partial or complete and/or fistula formation postoperative.
Periosteal membrane was reported to be used in a comparative study in rabbits versus that of resorbable collagen membrane to assess iliac bone graft resorption. The results seem promising. Periosteum as a membrane shows superior reparative powers.
In the past few years, periosteal membrane has been used in orthopedic surgery as well as periodontal surgery as a mechanism to promote bone healing without the ingrowth of fibrous tissues. It has shown its efficiency in maintaining the bone volume and density in postoperative follow up. This can in turn solve the problem of potential bone loss in patients of alveolar cleft.
The study aims to see if fixing the periosteum of the anterior ilium with tacks after bone graft application in the donor site will help maintain the graft and promote healing for the alveolar cleft patients.
The most common cause of poor lifestyle, speech and feeding for secondary alveolar cleft patient is the communication of the oral cavity with the nasal cavity. Radiation, teratogenic drugs, nutritional deficiency, chemical exposure, and maternal hypoxia are all predisposing factor to the incidence an infant developing cleft.
The main aims in reconstruction surgery are to achieve complete anatomical and functional seal to obtain normal speech, without regurgitation of fluids or food into the nasal cavity. Another goal is to allow for normal maxillary growth. Fistula occurring has high incidence in appearing postoperative to the reconstruction surgery. This leads to future difficult management. Another possible complication is wound dehiscence and graft exposure.
Several studies attempted to resolve the complications with different bone graft sources whether autogenous, xenograft or allograft. The literature shows the use of different membranes to preserve the graft such as: PRF, collagen membrane and pericardium or completely without.
The main objective for conducting this research is to check if the usage of periosteum of the same donor site of the anterior ilium will in fact preserve the bone graft volume and density of the known gold standard graft and prevent possible complications.
The Periosteal flap stretch with fixation using tacks overlying the bone graft in cleft patients. It will be compared to using the gold standard corticocancellous graft without use of periosteal membrane.
Periosteum is a specialized connective tissue forming a thin and fibrous membrane firmly anchored to bone. In children, it is thicker, more vascular, and more loosely attached. It has high bone forming potential. Many studies show that periosteum regenerates both bone and cartilage.
The periosteum consists of two layers; the outer layer containing fibroblasts, vessels and sharpey's fibers. The inner layer contains undifferentiated mesenchymal cells, capillaries, and osteoblasts. This induces hematoma followed by callus formation during healing as it triggers sequences of cellular and biochemical events.
- Conditions
- Alveolar Bone Grafting
- Being tested
- : delayed surgical repair of alveolar cleft using particulate cortico-cancellous anterior iliac bon
- Keywords
- alveolar cleft, alveolar cleft bone graft, periosteum membrane, anterior ilium bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
: delayed surgical repair of alveolar cleft using particulate cortico-cancellous anterior iliac bonProcedure or surgery
skin incision was marked 2-4 cm from the crest to anterior iliac spine height. This is done to avoid pain at the beltline if the incision is made directly over the anterior ilium. As well as avoid injury to the lateral femoral cutaneous nerve. After the anatomical marking are drawn using betadine solution, the site is injected with local anesthesia at the subcutaneous level. The skin incision line is made parallel to the iliac crest and posterior to the anterior iliac spine. Scalpel blade number 10 is used. The incision of the skin and subcutaneous fat was performed. Blunt dissection is carried out at the level of subcutaneous tissues to separate the fascia from fat. Cautery is used to control any hemorrhage. Using a number 15 blade, fascia was incised which covers the iliac spine. A hypo vascular plane was identified. It is located over the anterior iliac spine, as well as between the insertions of tensor fascia laterally and the external and the transverse abdominal muscles medially
| Study group | Role | What they receive |
|---|---|---|
| secondary surgical repair of alveolar cleft with cortico-cancellous anterior iliac bone graft. | Experimental | The cleft area is infiltrated with 1% xylocaine with epinephrine on the palatal and buccal side of the anterior maxilla. Two full thickness mucoperiosteal flaps are created by incising the anterior surface of the alveolar process, alongside the cleft ridge. The nasal mucosa is separated by an incision from the gingiva on both sides of maxilla. Flaps are lifted cautiously with a periosteal elevator along the labial surface of alveolar process to the piriform aperture. The nasal mucosa is reflected into the nose and the periosteum out of the cleft so that new bone can be grafted. The autogenic bone fills the cleft fissure, and it is covered with lifted flaps. The incision of mucous flap for covering clefts can be moved from the lateral sides of the alveolar process. It is advised to place the bone graft in the region of the piriform aperture to provide elevation and support for the base of ala nasi on the cleft. The skin incision line is made parallel to the iliac crest. Receives: Procedure: : delayed surgical repair of alveolar cleft using particulate cortico-cancellous anterior iliac bon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone gain
CBCT , measured in cm
Measured: 0-6 months
Bone Density
CBCT , measured in Hounsfield units.
Measured: Preoperative, 1week postoperative & sixth months.
Secondary outcomes (5)
Pain at Donor site
Visual Analogue scale from 0 to 10.
Measured: Immediate postoperative. 6 months
Pain at Recipient site
Visual Analogue scale from 0 to 10.
Measured: Immediate postoperative. 6 months
Infection
Yes/no
Measured: Immediate postoperative
Patient satisfaction
Yes/NO
Measured: Immediate postoperative and 6months.
Wound healing at donor and recipient site
Clinical photos
Measured: Immediate postoperative. 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (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 Alveolar Bone GraftingStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nesma Mattar
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Nesma Mattar, Cairo University
- Investigators
- Tarek El faramawi, Lecturer of OMFS, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795919
- Sponsor's protocol ID
- Bone graft in alveolar cleft
- Acronym
- periosteum
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abu-Shahba AG, Wilkman T, Kornilov R, Adam M, Salla KM, Linden J, Lappalainen AK, Bjorkstrand R, Seppanen-Kaijansinkko R, Mannerstrom B. Periosteal Flaps Enhance Prefabricated Engineered Bone Reparative Potential. J Dent Res. 2022 Feb;101(2):166-176. doi: 10.1177/00220345211037247. Epub 2021 Sep 11.
PubMed 34514892
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Particulate Cortico- Cancellous Anterior Iliac Graft with Periosteal Membrane in Treatment of Unilateral Alveolar Cleft Grafting Versus Particulate Cortico-cancellous Anterior Iliac Grafting Alone a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06795919
- Acronym / sponsor ID
- periosteum / Bone graft in alveolar cleft
- Conditions
- Alveolar Bone Grafting
- Keywords
- alveolar cleft, alveolar cleft bone graft, periosteum membrane, anterior ilium bone graft
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nesma MattarUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Mar 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jan 2025 (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.
In the past few years, periosteal membrane has been used in orthopedic surgery as well as periodontal surgery as a mechanism to promote bone healing without the ingrowth of fibrous tissues. It has shown its efficiency in maintaining the bone volume and density in postoperative follow up. This can in turn solve the problem of potential bone loss in patients of alveolar cleft.
The study aims to see if fixing the periosteum of the anterior ilium with tacks after bone graft application in the donor site will help maintain the graft and promote healing for the alveolar cleft patients
Detailed description
Cleft lip and palate are the most common congenital deformity affecting craniofacial structures. Delayed alveolar cleft defect presents a challenge for reconstruction to achieve functional and esthetic results. Many sources of bone graft have been shown in the literature: cortical or cancellous bone, iliac crest, cranial bone, mandibular symphysis, tibia, and rib. The main complication is graft loss partial or complete and/or fistula formation postoperative.
Periosteal membrane was reported to be used in a comparative study in rabbits versus that of resorbable collagen membrane to assess iliac bone graft resorption. The results seem promising. Periosteum as a membrane shows superior reparative powers.
In the past few years, periosteal membrane has been used in orthopedic surgery as well as periodontal surgery as a mechanism to promote bone healing without the ingrowth of fibrous tissues. It has shown its efficiency in maintaining the bone volume and density in postoperative follow up. This can in turn solve the problem of potential bone loss in patients of alveolar cleft.
The study aims to see if fixing the periosteum of the anterior ilium with tacks after bone graft application in the donor site will help maintain the graft and promote healing for the alveolar cleft patients.
The most common cause of poor lifestyle, speech and feeding for secondary alveolar cleft patient is the communication of the oral cavity with the nasal cavity. Radiation, teratogenic drugs, nutritional deficiency, chemical exposure, and maternal hypoxia are all predisposing factor to the incidence an infant developing cleft.
The main aims in reconstruction surgery are to achieve complete anatomical and functional seal to obtain normal speech, without regurgitation of fluids or food into the nasal cavity. Another goal is to allow for normal maxillary growth. Fistula occurring has high incidence in appearing postoperative to the reconstruction surgery. This leads to future difficult management. Another possible complication is wound dehiscence and graft exposure.
Several studies attempted to resolve the complications with different bone graft sources whether autogenous, xenograft or allograft. The literature shows the use of different membranes to preserve the graft such as: PRF, collagen membrane and pericardium or completely without.
The main objective for conducting this research is to check if the usage of periosteum of the same donor site of the anterior ilium will in fact preserve the bone graft volume and density of the known gold standard graft and prevent possible complications.
The Periosteal flap stretch with fixation using tacks overlying the bone graft in cleft patients. It will be compared to using the gold standard corticocancellous graft without use of periosteal membrane.
Periosteum is a specialized connective tissue forming a thin and fibrous membrane firmly anchored to bone. In children, it is thicker, more vascular, and more loosely attached. It has high bone forming potential. Many studies show that periosteum regenerates both bone and cartilage.
The periosteum consists of two layers; the outer layer containing fibroblasts, vessels and sharpey's fibers. The inner layer contains undifferentiated mesenchymal cells, capillaries, and osteoblasts. This induces hematoma followed by callus formation during healing as it triggers sequences of cellular and biochemical events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| secondary surgical repair of alveolar cleft with cortico-cancellous anterior iliac bone graft. | Experimental | Procedure: : delayed surgical repair of alveolar cleft using particulate cortico-cancellous anterior iliac bonThe cleft area is infiltrated with 1% xylocaine with epinephrine on the palatal and buccal side of the anterior maxilla. Two full thickness mucoperiosteal flaps are created by incising the anterior surface of the alveolar process, alongside the cleft ridge. The nasal mucosa is separated by an incision from the gingiva on both sides of maxilla. Flaps are lifted cautiously with a periosteal elevator along the labial surface of alveolar process to the piriform aperture. The nasal mucosa is reflected into the nose and the periosteum out of the cleft so that new bone can be grafted. The autogenic bone fills the cleft fissure, and it is covered with lifted flaps. The incision of mucous flap for covering clefts can be moved from the lateral sides of the alveolar process. It is advised to place the bone graft in the region of the piriform aperture to provide elevation and support for the base of ala nasi on the cleft. The skin incision line is made parallel to the iliac crest. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 9 -12 years, depending on dental age not chronological.
- systemically healthy patients (American Society of Anesthesiologists -ASA I and II)
- Patients secondary alveolar cleft patient.
Key exclusion criteria (4 listed)
- Patients with recurrent palatal fistula.
- Existence of syndromic cleft palate.
- Patient with uncontrolled systematic disease.
- Patients undergoing radiotherapy or chemotherapy for malignancy.
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 |
|---|---|---|
| : delayed surgical repair of alveolar cleft using particulate cortico-cancellous anterior iliac bonskin incision was marked 2-4 cm from the crest to anterior iliac spine height. This is done to avoid pain at the beltline if the incision is made directly over the anterior ilium. As well as avoid injury to the lateral femoral cutaneous nerve. After the anatomical marking are drawn using betadine solution, the site is injected with local anesthesia at the subcutaneous level. The skin incision line is made parallel to the iliac crest and posterior to the anterior iliac spine. Scalpel blade number 10 is used. The incision of the skin and subcutaneous fat was performed. Blunt dissection is carried out at the level of subcutaneous tissues to separate the fascia from fat. Cautery is used to control any hemorrhage. Using a number 15 blade, fascia was incised which covers the iliac spine. A hypo vascular plane was identified. It is located over the anterior iliac spine, as well as between the insertions of tensor fascia laterally and the external and the transverse abdominal muscles medially | Procedure or surgery | secondary surgical repair of alveolar cleft with cortico-cancellous anterior iliac bone graft. |
Primary outcome
Bone gain
Time frame: 0-6 months
CBCT , measured in cm
Bone Density
Time frame: Preoperative, 1week postoperative & sixth months.
CBCT , measured in Hounsfield units.
5 secondary outcomes
Pain at Donor site
Time frame: Immediate postoperative. 6 months
Pain at Recipient site
Time frame: Immediate postoperative. 6 months
Infection
Time frame: Immediate postoperative
Patient satisfaction
Time frame: Immediate postoperative and 6months.
Wound healing at donor and recipient site
Time frame: Immediate postoperative. 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Background: PubMed 34514892Abu-Shahba AG, Wilkman T, Kornilov R, Adam M, Salla KM, Linden J, Lappalainen AK, Bjorkstrand R, Seppanen-Kaijansinkko R, Mannerstrom B. Periosteal Flaps Enhance Prefabricated Engineered Bone Reparative Potential. J Dent Res. 2022 Feb;101(2):166-176. doi: 10.1177/00220345211037247. Epub 2021 Sep 11.
- Individual participant dataSharing planned: No
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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.
Nesma Mo Ibrahim, Lecturer Assistant of OMFS contact
Tarek El faramawi, Lecturer of OMFS study chair
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 : delayed surgical repair of alveolar cleft using particulate cortico-cancellous anterior iliac bon in people with Alveolar Bone Grafting, run by Nesma Mattar 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: opening soon, as of the sponsor's last update on 28 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nesma Mo Ibrahim, Lecturer Assistant of OMFS (nesmamattar@outlook.com ext. 00201000750518, nesmamattar@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone gain (time frame: 0-6 months). The study lists 2 primary outcomes in all. 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 NCT06795919, 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 Jan 2025.