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Recruitment centers
#1
Name of recruitment center - English: Tehran University of Medical Sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Prof. Mohammad Bayat
Full name of responsible person - Persian: پرفسور محمد بیات
Street address - English: Shariati Hospital, North Kargar,The main building, Floor 4, Research Center for Oral and CranioMaxillofacial Surgery,Tehran, Iran
Street address - Persian: تهران- کارگر شمالی- انتهای سه راه جلال آل احمد- بیمارستان آموزشی، پژوهشی و درمانی دکتر علی شریعتی، ساختمان اصلی، طبقه 4، مرکز تحقیقات جراحی فک و صورت
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۳۹۹۵۵۹۹۱
Phone: +98 21 8490 2473
Fax: +98 21 8490 2473
Email: bayatm@tums.ac.ir
Web page address: https://cmfrc.tums.ac.ir/site/contact?lang=en
Name of recruitment center - English: Iran University of Medical Sciences
Name of recruitment center - Persian: دانشگاه علوم پزشکی ایران
Full name of responsible person - English: Shima Tavakol
Full name of responsible person - Persian: شیما توکل
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: تهران
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8862 2578
Fax: +98 21 8862 2578
Email: shima.tavakol@yahoo.com
Web page address:
Name of recruitment center - English: TehranIran University of Medical Sciences Name of recruitment center - Persian: دانشگاه علوم پزشکی تهرانایران Full name of responsible person - English: Prof. Mohammad BayatShima Tavakol Full name of responsible person - Persian: پرفسور محمد بیاتشیما توکل Street address - English: Shariati HospitalIran University of Medical Sciences, North Kargar,The main buildingShahid Hemmat Highway, Floor 4Tehran, Research Center for Oral and CranioMaxillofacial Surgery,Tehran, IranIRAN Street address - Persian: تهران- کارگر شمالی- انتهای سه راه جلال آل احمد- بیمارستان آموزشی، پژوهشی و درمانی دکتر علی شریعتیبزرگراه همت جنب برج میلاد، ساختمان اصلی، طبقه 4، مرکز تحقیقات جراحی فک و صورتدانشگاه علوم پزشکی ایران City - English: Tehranتهران City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۳۹۹۵۵۹۹۱1449614535 Phone: +98 21 8490 24738862 2578 Fax: +98 21 8490 24738862 2578 Email: bayatmshima.tavakol@tums.ac.iryahoo.com Web page address: https://cmfrc.tums.ac.ir/site/contact?lang=en
#2
Name of recruitment center - English: Clinic of Dr. Hamidreza Barikani
Name of recruitment center - Persian: مطب دکتر حمیدرضا باریکانی
Full name of responsible person - English: Dr. Hamidreza Barikani
Full name of responsible person - Persian: دکتر حمیدرضا باریکانی
Street address - English: Floor 1, No 4, Sattari BLVD, Jordan St, Tehran
Street address - Persian: خیابان جردن، بلوار ستاری , پلاک ۴ , طبقه اول
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 0000000000
Phone: +98 912 384 4986
Fax:
Email: barikani52@gmail.com
Web page address:
Name of recruitment center - English: Clinic of Dr. Hamidreza Barikani Name of recruitment center - Persian: مطب دکتر حمیدرضا باریکانی Full name of responsible person - English: Dr. Hamidreza Barikani Full name of responsible person - Persian: دکتر حمیدرضا باریکانی Street address - English: Floor 1, No 4, Sattari BLVD, Jordan St, Tehran Street address - Persian: خیابان جردن، بلوار ستاری , پلاک ۴ , طبقه اول City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 0000000000 Phone: +98 912 384 4986 Fax: Email: barikani52@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mohammad Taghi Joghataei
Full name of responsible person - Persian: محمد تقی جغتایی
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8670 4722
Fax:
Email: joghataei.mt@iums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyed Abbas Motevalian
Full name of responsible person - Persian: سیدعباس متولیان
Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1449614535
Phone: +98 21 8862 2552
Fax: +98 21 8862 2703
Email: amotevalian@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Mohammad Taghi JoghataeiSeyed Abbas Motevalian Full name of responsible person - Persian: محمد تقی جغتاییسیدعباس متولیان Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Street address - Persian: تهران، بزرگراه همت جنب برج میلاد، دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1449614535 Phone: +98 21 8670 47228862 2552 Fax: +98 21 8862 2703 Email: joghataei.mtamotevalian@iums.ac.ir Web page address:
Protocol summary
Study aim
Evaluation of the effect of self-assembling peptide nanofibers in sinus cavity repair
Design
This study will be performed in phase 1-2 clinical trial and double-blind. The doctor and statistical specialist will not be aware of the materials and groups.
The sample size will be 18 people. According to calculations at Sealedenvelop.com, the selected rendering will be done in 6 groups of 3.
Parallel in groups include:
1- Bone powder
2- Self-assembled nanofiber peptide group
3- Combined group of bone powder and nanofiber peptide in proportion to ½
Settings and conduct
Sampling and surgeries will be performed at Tehran University of Medical Sciences.
After surgery and implantation of biomaterials, after 2 weeks and 6 months, the following examinations will be performed:
1- Evaluation of pain and wound healing after 2 weeks
2- Evaluation of changes in vertical bone height, implant stability and monitoring of osteointegration after 6 months
3- Qualitative histomorphometric analysis after implantation
Physicians and statisticians will not be aware of the materials and groups.
Participants/Inclusion and exclusion criteria
Inclusion factors:
1. Age 18 years to 70 years
2. Gender: male and female
3. Need sinus augmentation
4. The height between the maxillary sinus and the alveolar crown should be less than 8 mm
5. The patient has oral health
6. Do not have maxillary sinus diseases
Exclusion factors
1. Smoking and tobacco
2. Pregnancy and lactation
3. Uncontrolled diabetes
4. Immune diseases
5. Cancer and undergoing chemotherapy
Intervention groups
1- Bone powder
2- Self- assembling peptide nanofiber
3- combination of bone powder and self- assembling peptide nanofiber
Main outcome variables
1- Pain 2- Wound healing 3- Stability of the implant 4- Quality of bone tissue 5- Amount of vertical height
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210526051407N1
Registration date:2021-06-27, 1400/04/06
Registration timing:prospective
Last update:2022-12-01, 1401/09/10
Update count:1
Registration date
2021-06-27, 1400/04/06
Registrant information
Name
Shima Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4722
Email address
tavakol.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-06, 1400/04/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical trial of self-assembling peptide nanofiber in sinus cavity repair
Public title
Evaluation of clinical trial of self-assembling peptide nanofiber in sinus cavity repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient will require sinus augmentation
bone height between alveolar crest and maxillary sinus less than 8 millimetres.
Patient has good oral and dental hygiene
Do not have maxillary sinus diseases
Exclusion criteria:
Smoking
Pregnancy and lactation
Uncontrolled diabetes
Alcohol consumption
Autoimmune diseases
Cancer and undergoing chemotherapy
Age
From 18 years old to 70 years old
Gender
Both
Phase
1-2
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
18
Randomization (investigator's opinion)
Randomized
Randomization description
Selective randomization will be performed based on calculations at Sealedenvelop.com. Randomization will be done in 6 groups of 3 blocks in the form of A, B and C, according to which patients will receive medication interventions.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is two-way.
1- The doctor who places the material in the sinus cavity does not know the type of implanted material as a clinical caregiver.
2- The statistical expert who analyzes the results does not know about the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sceinces
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-06-07, 1400/03/17
Ethics committee reference number
IR.IUMS.REC.1400.218
Health conditions studied
1
Description of health condition studied
Bone resorption in the maxilla
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
The fourteenth day
Method of measurement
McGill Pain Questionnaire (MPQ)
2
Description
Wound healing
Timepoint
The fourteenth day
Method of measurement
Using dental tweezers by examining alveolar osteitis based on BLUM'S criteria
3
Description
The amount of vertical height
Timepoint
Baseline and after 6 months
Method of measurement
CBCT
4
Description
Implant stability
Timepoint
After 6 months
Method of measurement
OSTELL
5
Description
Bone tissue quality
Timepoint
Post-implantation
Method of measurement
Tissue staining
Secondary outcomes
empty
Intervention groups
1
Description
Second Intervention group: Self-assembling peptide nanofiber (the company-made) is placed in a single dose (1 ml) to repair the sinus cavity and is tested for 6 months.
Category
Treatment - Drugs
2
Description
Third Intervention group: The combined group of bone powder (0.5 gr) and Self-assembling peptide nanofiber (0.5 ml) in a single dose is placed to repair the sinus cavity and is examined for 6 months.
Category
Treatment - Drugs
3
Description
Control group: Bone powder of Iranian Tissue Product Company is placed in a single dose (one gram) to repair the sinus cavity and is examined for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences
Full name of responsible person
Shima Tavakol
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran, IRAN
City
تهران
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2578
Fax
+98 21 8862 2578
Email
shima.tavakol@yahoo.com
Web page address
2
Recruitment center
Name of recruitment center
Clinic of Dr. Hamidreza Barikani
Full name of responsible person
Dr. Hamidreza Barikani
Street address
Floor 1, No 4, Sattari BLVD, Jordan St, Tehran
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 912 384 4986
Email
barikani52@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2552
Fax
+98 21 8862 2703
Email
amotevalian@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Knowledge enterprise company “Tavakol Pars Biomimetic Technologies Company
Full name of responsible person
Shima Tavakol
Street address
No 5, Amirkabir st, Kashan, Isfahan, Iran
City
Kashan
Province
Isfehan
Postal code
8718693111
Phone
+98 21 8862 2578
Email
shima.tavakol@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Knowledge enterprise company “Tavakol Pars Biomimetic Technologies Company
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shima Tavakol
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran