Cleft of Alveolar RidgePhase 1NCT02859025
Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone in Alveolar Cleft Osteoplasty
A Phase 1 study testing anterior iliac crest graft, lateral ramus cortical bone+BFPSC+NBBM and anterior iliac crest graft+BFPSC+NBBM in people with Cleft of Alveolar Ridge, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Our aim was to combine regenerative techniques with bone grafting in human models to increase predictability and survival of reconstructed tissue. The MSCs in this study were derived from an intra oral fat source (BFP) and were cultured over natural bovine bone mineral granules and delivered within the lateral ramus… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cleft of Alveolar Ridge
- What is being tested?
- anterior iliac crest graft, lateral ramus cortical bone+BFPSC+NBBM and anterior iliac crest graft+BFPSC+NBBM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- Jan 2015to Feb 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Unilateral congenital cleft lip and palate
- Previous presurgical orthodontic treatment
Who cannot join
- History of malignancy
- History of radiation
- History of chemotherapy
- Pregnancy
- Systemic diseases contradicting dental and surgical treatments
- Conditions or drugs affecting bone remodeling or bone metabolism and connective tissue
- Allergy to collagen
Trial locations and contacts
1 site in 1 country.
Iran1 site
School of Dentristry at Shahid Beheshti University of Medical Sciences
Tehran, Tehran Province, 19839
About this study
Official title: Lateral Ramus Cortical Bone Plate in Alveolar Cleft Osteoplasty: Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone in a Preliminary Study
Our aim was to combine regenerative techniques with bone grafting in human models to increase predictability and survival of reconstructed tissue. The MSCs in this study were derived from an intra oral fat source (BFP) and were cultured over natural bovine bone mineral granules and delivered within the lateral ramus cortical bone plate (LRCP)to treat human alveolar cleft defects.
Read the detailed description
Patients enrolled in the present study were suffering from alveolar cleft and had previously received orthodontic treatment and only required secondary alveolar grafting. The buccal fat pad derived stem cells (BFPSCs) were harvested from buccal fat pad tissues of the patients. Patients were divided into 3 groups. Group A , the control group, was treated with anterior iliac crest (AIC) spongy bone to fill defects, followed by coverage with collagen membrane. Group B was treated with lateral ramus cortical bone cage (LRCP), used to create a protected healing space by fixing it to adjacent walls of the cleft defect. Group C was treated with (AIC) as in Group 1, but BFP-derived MSCs cultured over NBBM were put over the spongy bone and covered with a collagen membrane.Passage 3 BFPSCs were loaded on the implants ( Cerabone (Botiss, Berlin, Germany) a natural bovine bone mineral (NBBM); a granular biomaterial with a 200- to 850-µm particle size) 3 days prior to transplantation.Cone beam computed tomography (CBCT) was obtained after 6 months.
- Conditions
- Cleft of Alveolar Ridge
- Being tested
- anterior iliac crest graft, lateral ramus cortical bone+BFPSC+NBBM, anterior iliac crest graft+BFPSC+NBBM
- Keywords
- Alveolar cleft, Osteoplasty, Tissue engineering, Stem cells, Regenerative medicine, Bone, Lateral ramus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior iliac crest graftBiological
Anterior iliac crest spongy bone filled the defects followed by coverage with collagen membrane.
lateral ramus cortical bone+BFPSC+NBBMBiological
ramus cortical bone cage created a protected healing space and BFPSCs cultured over NBBM were put over the graft.
anterior iliac crest graft+BFPSC+NBBMBiological
Anterior iliac crest spongy bone filled the defects and BFPSCs cultured over NBBM were put over the spongy bone.
| Study group | Role | What they receive |
|---|---|---|
| A:Iiac | Active comparator | Treated with anterior iliac crest spongy bone to fill defects, followed by coverage with collagen membrane. Receives: Biological: anterior iliac crest graft |
| B:MSCs+LRCP | Experimental | Treated with lateral ramus cortical bone plate (LRCP) to create a protected healing space by fixing it to adjacent walls of the cleft defect. BFPScs were loaded on NBBM and delivered to the defect Receives: Biological: lateral ramus cortical bone+BFPSC+NBBM |
| C:MSCs+liac | Experimental | Treated with anterior iliac crest spongy bone as in Group 1, but BFP-derived mesenchymal stem cells (MSCs ) cultured over NBBM were put over the spongy bone and covered with a collagen membrane. Receives: Biological: anterior iliac crest graft+BFPSC+NBBM |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in bone volume
1-mm coronal sections of the treated region were taken before and after surgery, and new bone formation was assessed by CBCT.
Measured: before the surgery and 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionFeb 2016
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 Cleft of Alveolar RidgeStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arash Khojasteh, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859025
- Sponsor's protocol ID
- sbmu9221
- Status last verified
- Aug 2016
- First submitted
- 30 Jul 2016
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Khojasteh A, Kheiri L, Behnia H, Tehranchi A, Nazeman P, Nadjmi N, Soleimani M. Lateral Ramus Cortical Bone Plate in Alveolar Cleft Osteoplasty with Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone: Phase I Clinical Trial. Biomed Res Int. 2017;2017:6560234. doi: 10.1155/2017/6560234. Epub 2017 Dec 12.
PubMed 29379800
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Ramus Cortical Bone Plate in Alveolar Cleft Osteoplasty: Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone in a Preliminary Study
- ClinicalTrials.gov ID
- NCT02859025
- Acronym / sponsor ID
- sbmu9221
- Conditions
- Cleft of Alveolar Ridge
- Keywords
- Alveolar cleft, Osteoplasty, Tissue engineering, Stem cells, Regenerative medicine, Bone, Lateral ramus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Aug 2016 (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.
Our aim was to combine regenerative techniques with bone grafting in human models to increase predictability and survival of reconstructed tissue. The MSCs in this study were derived from an intra oral fat source (BFP) and were cultured over natural bovine bone mineral granules and delivered within the lateral ramus cortical bone plate (LRCP)to treat human alveolar cleft defects.
Detailed description
Patients enrolled in the present study were suffering from alveolar cleft and had previously received orthodontic treatment and only required secondary alveolar grafting. The buccal fat pad derived stem cells (BFPSCs) were harvested from buccal fat pad tissues of the patients. Patients were divided into 3 groups. Group A , the control group, was treated with anterior iliac crest (AIC) spongy bone to fill defects, followed by coverage with collagen membrane. Group B was treated with lateral ramus cortical bone cage (LRCP), used to create a protected healing space by fixing it to adjacent walls of the cleft defect. Group C was treated with (AIC) as in Group 1, but BFP-derived MSCs cultured over NBBM were put over the spongy bone and covered with a collagen membrane.Passage 3 BFPSCs were loaded on the implants ( Cerabone (Botiss, Berlin, Germany) a natural bovine bone mineral (NBBM); a granular biomaterial with a 200- to 850-µm particle size) 3 days prior to transplantation.Cone beam computed tomography (CBCT) was obtained after 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A:Iiac | Active comparator | Biological: anterior iliac crest graftTreated with anterior iliac crest spongy bone to fill defects, followed by coverage with collagen membrane. |
| B:MSCs+LRCP | Experimental | Biological: lateral ramus cortical bone+BFPSC+NBBMTreated with lateral ramus cortical bone plate (LRCP) to create a protected healing space by fixing it to adjacent walls of the cleft defect. BFPScs were loaded on NBBM and delivered to the defect |
| C:MSCs+liac | Experimental | Biological: anterior iliac crest graft+BFPSC+NBBMTreated with anterior iliac crest spongy bone as in Group 1, but BFP-derived mesenchymal stem cells (MSCs ) cultured over NBBM were put over the spongy bone and covered with a collagen membrane. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral congenital cleft lip and palate
- Previous presurgical orthodontic treatment
Key exclusion criteria (7 listed)
- History of malignancy
- History of radiation
- History of chemotherapy
- Pregnancy
- Systemic diseases contradicting dental and surgical treatments
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 |
|---|---|---|
| anterior iliac crest graftAnterior iliac crest spongy bone filled the defects followed by coverage with collagen membrane. | Biological | A:Iiac |
| lateral ramus cortical bone+BFPSC+NBBMramus cortical bone cage created a protected healing space and BFPSCs cultured over NBBM were put over the graft. | Biological | B:MSCs+LRCP |
| anterior iliac crest graft+BFPSC+NBBMAnterior iliac crest spongy bone filled the defects and BFPSCs cultured over NBBM were put over the spongy bone. | Biological | C:MSCs+liac |
Primary outcome
change in bone volume
Time frame: before the surgery and 6 months after the surgery
1-mm coronal sections of the treated region were taken before and after surgery, and new bone formation was assessed by CBCT.
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 8 Aug 2016.
- Derived from this study: PubMed 29379800Khojasteh A, Kheiri L, Behnia H, Tehranchi A, Nazeman P, Nadjmi N, Soleimani M. Lateral Ramus Cortical Bone Plate in Alveolar Cleft Osteoplasty with Concomitant Use of Buccal Fat Pad Derived Cells and Autogenous Bone: Phase I Clinical Trial. Biomed Res Int. 2017;2017:6560234. doi: 10.1155/2017/6560234. Epub 2017 Dec 12.
Related trials for Cleft of Alveolar Ridge
Not yet recruitingPhase 3
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
Cleft Lip Palate
Active, not recruiting
Assessment of Bone Volume Using Patient Specific Autogenous Bone Plug Versus Particulate Autogenous Bone for Unilateral Alveolar Ridge Reconstruction
Alveolar Cleft Grafting
Recruiting
Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery
Orofacial Clefts, Cleft Lip and Palate
Active, not recruiting
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.
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 Phase 1 study testing anterior iliac crest graft, lateral ramus cortical bone+BFPSC+NBBM and anterior iliac crest graft+BFPSC+NBBM in people with Cleft of Alveolar Ridge, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 7 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 8 Aug 2016. 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 Iran. 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?
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 bone volume (time frame: before the surgery and 6 months after the surgery). 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 NCT02859025, 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 8 Aug 2016.