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Investigation of the effect of a 3D printed biocompatible composite scaffold customized for the patient with the use of buccal fat pad micrograft on regeneration of bone defects in the patients with palatal and alveolar bone cleft

Protocol summary

Study aim
The aim of the current study is to fabricate a customized biocompatible 3D printed scaffold and use in combination with BFP- SVF for human alveolar cleft reconstruction.
Design
Phase 1 of clinical trial with control group and one-sided blind with no randomization on 10 patients
Settings and conduct
Patients referred to Ayatollah Taleghani Hospital (Tehran, Iran) are selected according to the inclusion and exclusion criteria. By an experienced oral and maxillofacial surgeon and under general anesthesia the test patients are treated by the 3D printed customized scaffold with buccal fat pad micro graft, and the control patients by autogenous iliac bone graft. CBCT images obtained 6 months after the surgery are evaluated by an experienced blind radiologist.
Participants/Inclusion and exclusion criteria
The inclusion criteria include: 1. patient with alveolar or palatal cleft, 2. Defect size more than 2 cm3, 3. Soft tissue deficiency is not seen, 4. Maxillary sinus is not involved, 5. Dental dehiscence or fenestration is not seen. The exclusion criteria include: 1. Autoimmune or metabolic or systemic diseases 2. Peripheral vascular diseases, 3. Marble bone disease or osteoporosis, 4. Smoking or alcohol consumption, 5. Conditions which compromise wound healing process, 6. Being in breastfeeding or pregnancy.
Intervention groups
1. Alveolar cleft treated by the 3D printed composite scaffold with buccal fat pad micrograft 2. Alveolar cleft treated by autogenous iliac bone graft
Main outcome variables
In the previous cleft region, height, width, and length of the alveolar ridge, newly formed bone density, bone to construct contact are evaluated. In histologic analysis, the rate of new bone formation, the rate of fibrosis or necrosis (if seen), foreign body reaction (if seen), and the rate of remained scaffold are evaluated.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191002044949N1
Registration date: 2022-01-11, 1400/10/21
Registration timing: registered_while_recruiting

Last update: 2022-01-11, 1400/10/21
Update count: 0
Registration date
2022-01-11, 1400/10/21
Registrant information
Name
Farshid Bastami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2217 5350
Email address
farshidbst@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-20, 1400/01/31
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of a 3D printed biocompatible composite scaffold customized for the patient with the use of buccal fat pad micrograft on regeneration of bone defects in the patients with palatal and alveolar bone cleft
Public title
Reconstruction of palatal cleft using 3D printer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with alveolar or palatal cleft Defect size more than 2 cm3 soft tissue deficiency is not seen maxillary sinus is not involved Dental dehiscence or fenestration is not seen
Exclusion criteria:
autoimmune or metabolic or systemic diseases peripheral vascular diseases marble bone disease or osteoporosis smoking or alcohol consuption conditions which compromise wound healing process being in breastfeeding or pregnancy
Age
From 10 years old
Gender
Both
Phase
1
Groups that have been masked
  • Investigator
Sample size
Target sample size: 10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The investigators has not been informed about the patients' code. Investigators include a radiologist for obtaining CBCT and a person who evaluate informations by Materialise Mimics (3D Medical Image Processing Software).
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee, School of Dentistry, Shahid Beheshti Univerisity of Medical Sciences
Street address
Evin, Daneshju boulevard
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2019-06-17, 1398/03/27
Ethics committee reference number
IR.SBMU.DRC.REC.1398.123

Health conditions studied

1

Description of health condition studied
Maxillary alveolar cleft
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Height, width and length of the ridge at the alveolar defect site in test group in comparison with the control group
Timepoint
6 month after surgery
Method of measurement
CBCT scan

2

Description
New formed bone density at the alveolar defect site in test group in comparison with the control group
Timepoint
6 month after surgery
Method of measurement
Radio morphometry using CBCT scan

3

Description
Native bone and scaffold contact at the alveolar defect site in test group in comparison with the control group
Timepoint
6 month after surgery
Method of measurement
CBCT scan

4

Description
The rate of new bone formation at the alveolar defect site in test group in comparison with the control group
Timepoint
6 month after surgery
Method of measurement
Histologic assessment by H&E staining

5

Description
The rate of fibrosis or necrosis if exists at the alveolar defect site in test group in comparison with the control group
Timepoint
6 month after surgery
Method of measurement
Histologic assessment by H&E staining

6

Description
Foreign body reaction if exists at the alveolar defect site in test group in comparison with the control group
Timepoint
6 month after surgery
Method of measurement
Histologic assessment by H&E staining

7

Description
The rate of scaffold remnants if exists at the alveolar defect site in test group in comparison with the control group
Timepoint
6 month after surgery
Method of measurement
Histologic assessment by H&E staining

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Gelatin (5-20 wt%)/ alginate (1-4 wt%)/ allograft (10-40 wt%) in combination with buccal fat pad micrograft. Gelatin with medical grade is purchased from Nitta Gelatin Co, China, Alginate with medical grade from KIMICA co, Japan, and allograft bone powder from Iranian Tissue Product company (RegenTM). Buccal fat pad micrograft is obtain by using a novel mechanical device, called Minceolip, was patented by our team in the Intellectual Property Office of Real Estate Registration Organization of Iran (Application Number 13985040003006638). Safety of Buccal fat pad micrograft was performed clinically according to a study approved by the Ethical Committee of the Shahid Beheshti University of Medical Sciences (Approval number IR.SBMU.REC.1398.061), and Iranian Registry of Clinical Trials (IRCT) with IRCT code 20181205041860N1 on September 26, 2019.
Category
Rehabilitation

2

Description
Control group: Autogenous bone graft harvested from anterior crest of iliac bone which is the gold standard treatment of alveolar bone defects reconstruction.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Arash Khojasteh
Street address
Shahid Aarabi street, Evin
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Fax
+98 21 2243 2570
Email
taleghanihospital@sbmu.ac.ir
Web page address
https://taleghani.sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Evin, Shahid Aarabi street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farshid Bastami
Position
Oral and Maxillofacial Surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo st, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Fax
Email
farshidbst@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farshid Bastami
Position
Oral and Maxillofacial Surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo st, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Fax
Email
farshidbst@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
َArash Khojasteh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Shahid Beheshti University, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2242 7752
Email
arashkhojasteh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only demographic factors information such as age and gender, and CBCT images and clinical views of surgery can be shared by a scientific article when the patient is unidentifiable.
When the data will become available and for how long
The data will become available 6 months after publication.
To whom data/document is available
All researchers can apply to receive the data.
Under which criteria data/document could be used
It is possible for researchers to use our data or documentation to conduct research and clinical studies while maintaining ethical conditions.
From where data/document is obtainable
Applicants can contact Dr. Farshid Bastami with the following information and express their application: Email: farshidbst@gmail.com Tel: 00989126704434
What processes are involved for a request to access data/document
Applicants must submit a clear length of the email and submit their application. After evaluating the applicant and his/her request, he/she will be given an appropriate response at the earliest time (at least after a week).
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