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Intervention groups
#1
Intervention group: Osteogenic cocktail of self-assembling peptide nanofiber (the company-made) is placed in a single dose (0.5 cc) to repair the extracted tooth cavity and is evaluated for 2 months.
Intervention group: Osteogenic cocktail of self-assembling peptide nanofiber (the company-made) is placed in a single dose (0.25 cc) to repair the extracted tooth cavity and is evaluated for 2 months.
Intervention group: Osteogenic cocktail of self-assembling peptide nanofiber (the company-made) is placed in a single dose (0.50.25 cc) to repair the extracted tooth cavity and is evaluated for 2 months.
گروه مداخله: کوکتیل استخوانساز نانوفیبرپپتیدی خودارا (ساخته شده توسط شرکت) بصورت تک دوز ( نیم سی سی) جهت ترمیم حفره ی دندان کشیده در محل قرار داده می شود و به مدت 2 ماه بررسی می گردد.
گروه مداخله: کوکتیل استخوانساز نانوفیبرپپتیدی خودارا (ساخته شده توسط شرکت) بصورت تک دوز ( 250 میکرولیتر) جهت ترمیم حفره ی دندان کشیده در محل قرار داده می شود و به مدت 2 ماه بررسی می گردد.
گروه مداخله: کوکتیل استخوانساز نانوفیبرپپتیدی خودارا (ساخته شده توسط شرکت) بصورت تک دوز ( نیم سی سی250 میکرولیتر) جهت ترمیم حفره ی دندان کشیده در محل قرار داده می شود و به مدت 2 ماه بررسی می گردد.
#2
Control group: PBS is placed in a single dose (0.5 cc) to repair the extracted tooth cavity and is evaluated for 2 months.
Control group: PBS is placed in a single dose (0.25 cc) to repair the extracted tooth cavity and is evaluated for 2 months.
Control group: PBS is placed in a single dose (0.50.25 cc) to repair the extracted tooth cavity and is evaluated for 2 months.
گروه کنترل: فسفات بافر سالین بصورت تک دوز ( نیم سی سی) جهت ترمیم حفره ی دندان کشیده در محل قرار داده می شود و به مدت 2 ماه بررسی می گردد.
گروه کنترل: فسفات بافر سالین بصورت تک دوز ( 250 میکرولیتر) جهت ترمیم حفره ی دندان کشیده در محل قرار داده می شود و به مدت 2 ماه بررسی می گردد.
گروه کنترل: فسفات بافر سالین بصورت تک دوز ( نیم سی سی250 میکرولیتر) جهت ترمیم حفره ی دندان کشیده در محل قرار داده می شود و به مدت 2 ماه بررسی می گردد.
Recruitment centers
#1
Name of recruitment center - English: Tehran University of Medical Sciences- Dental Research Institute
Name of recruitment center - Persian: دانشگاه علوم پزشکی تهران-مرکز تحقیقات ایمپلنت های دندانی
Full name of responsible person - English: Shima Tavakol
Full name of responsible person - Persian: شیما توکل
Street address - English: Dental Implant Institute, Dentistry School, Qods st, Enghelab st, Tehran
Street address - Persian: تهران، خيابان انقلاب، خيابان قدس، دانشكده دندانپزشكي، مرکز تحقیقات ایمپلنت های دندانی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1416634793
Phone: +98 21 8338 4148
Fax:
Email: shima.tavakol@yahoo.com
Web page address:
Name of recruitment center - English: Tehran University of Medical Sciences- Dental Research Institute
Name of recruitment center - Persian: دانشگاه علوم پزشکی تهران-مرکز تحقیقات ایمپلنت های دندانی
Full name of responsible person - English: Shima Tavakol
Full name of responsible person - Persian: شیما توکل
Street address - English: Dental Implant Institute, Dentistry School, Qods st, Enghelab st, Tehran
Street address - Persian: تهران، خيابان انقلاب، خيابان قدس، دانشكده دندانپزشكي، مرکز تحقیقات ایمپلنت های دندانی
City - English: تهران
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1416634793
Phone: +98 21 8338 4148
Fax:
Email: shima.tavakol@yahoo.com
Web page address:
Name of recruitment center - English: Tehran University of Medical Sciences- Dental Research Institute Name of recruitment center - Persian: دانشگاه علوم پزشکی تهران-مرکز تحقیقات ایمپلنت های دندانی Full name of responsible person - English: Shima Tavakol Full name of responsible person - Persian: شیما توکل Street address - English: Dental Implant Institute, Dentistry School, Qods st, Enghelab st, Tehran Street address - Persian: تهران، خيابان انقلاب، خيابان قدس، دانشكده دندانپزشكي، مرکز تحقیقات ایمپلنت های دندانی City - English: Tehranتهران City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1416634793 Phone: +98 21 8338 4148 Fax: Email: shima.tavakol@yahoo.com Web page address:
#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:
Protocol summary
Study aim
Investigating the effect of self-assembling peptide nanofiber on the repair of the jaw bone
Design
This study will be performed in a phase 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 12 people. According to calculations at Sealedenvelop.com, the selected rendering will be done in 6 groups of 2. Parallel groups include 1- Self-assembled nanofiber peptide group 2- PBS
Settings and conduct
Sampling and surgeries will be performed at the Tehran University of Medical Sciences. After tooth extraction and implantation of biomaterials, on the first day, 7 and 14 using the oral scanner in terms of :
1. infection
2. The amount of soft tissue formation
They will be studied in comparison with the control group. Then, after 8 weeks, the amount of bone regeneration in the area will be evaluated using CBCT. Physicians and statisticians will not be aware of the materials and groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
1. Age 18 to 70 years
2. Gender: male and female
3. They need tooth extraction
4. The patient has oral and dental hygiene
Exclusion Criteria
1. Alcohol consumption
2. Pregnancy and breastfeeding
3. Uncontrolled diabetes
4. Autoimmune diseases
5.Cancer and undergoing chemotherapy
Intervention groups
1. An osteogenic cocktail of self-assembling peptide nanofiber (the company-made)
2. PBS
is placed in a single dose (0.5 cc) to repair the tooth-extracted cavity and is investigated for 2 months.
Main outcome variables
1. Infection
2. The amount of soft tissue formation
3. Bone regeneration
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210526051407N2
Registration date:2022-07-28, 1401/05/06
Registration timing:prospective
Last update:2022-12-09, 1401/09/18
Update count:1
Registration date
2022-07-28, 1401/05/06
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
2022-08-01, 1401/05/10
Expected recruitment end date
2023-08-01, 1402/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial evaluation of alveolar bone repair using self-assembling peptide nanofiber
Public title
Bone regeneration uing self-assembling peptide nanofiber
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient has good oral and dental hygiene
Patient will require tooth extraction
Exclusion criteria:
Alcohol consumption
Pregnancy and lactation
Uncontrolled diabetes
Autoimmune diseases
Cancer and undergoing chemotherapy
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
12
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 2 blocks in the form of A and B 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 tooth 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 Sciences
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-07-26, 1401/05/04
Ethics committee reference number
IR.IUMS.REC.1401.355
Health conditions studied
1
Description of health condition studied
Bone resorption in the jaw
ICD-10 code
M96.6
ICD-10 code description
Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate
Primary outcomes
1
Description
Infection
Timepoint
The Zero, 7th and 14th days
Method of measurement
Oral Scanner
2
Description
Repair of soft tissue
Timepoint
The Zero, 7th and 14th days
Method of measurement
Oral Scanner
Secondary outcomes
1
Description
Bone Regeneration
Timepoint
After 2 months
Method of measurement
Cone-beam computed tomography (CBCT)
Intervention groups
1
Description
Intervention group: Osteogenic cocktail of self-assembling peptide nanofiber (the company-made) is placed in a single dose (0.25 cc) to repair the extracted tooth cavity and is evaluated for 2 months.
Category
Treatment - Drugs
2
Description
Control group: PBS is placed in a single dose (0.25 cc) to repair the extracted tooth cavity and is evaluated for 2 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences- Dental Research Institute
Full name of responsible person
Shima Tavakol
Street address
Dental Implant Institute, Dentistry School, Qods st, Enghelab st, Tehran
City
تهران
Province
Tehran
Postal code
1416634793
Phone
+98 21 8338 4148
Email
shima.tavakol@yahoo.com
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
Hossein Keyvani
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
Keyvanlab@yahoo.com
Web page address
Grant name
Grant code / Reference number
1400-3-99-22545
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
+98 902 361 4037
Email
shima.tavakol@yahoo.com
Web page address
http://nanomimetic.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
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Iran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN