the effect of Concentrated Growth Factor(CGF) on healing outcome in maxillary sinus graft(histological examination)
Design
Clinical trial with parallel group, single-blind, randomized, phase 3 on 9 patients. The randomization method is simple and the unit is individual.
Settings and conduct
9 patients referring to Tabriz Dental School will enter the study. The patient's sinuses will be treated using the open lift technique and randomly placed CGF in a sinus and xenograft used in the other. After 6 months, the histological sample from the osteotomy site will be prepared and histological examination will be performed. The examiner does not know the type of sample sent to the laboratory.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Presence of bilateral posterior partial edentulousness or complete maxillary edentulousness; The remaining bone height between the alveolar crest and the sinus floor is less than 5mm . Exclusion criteria: Smokers; Pregnant women; Presence of pathological symptoms, cystic lesions, acute and chronic inflammatory disease, benign and malignant tumors in the sinus; Existence of systemic diseases such as uncontrolled diabetes, cardiovascular disease, malignancy, head and neck radiotherapy; Autoimmune diseases that make soft and hard tissue repair difficult 6.Use of steroid drugs and immunosuppressants - bisphosphonates; Existence of untreated and periapical periodontal diseases, especially in the teeth adjacent to the sinus floor
Intervention groups
1) CGF is placed in the sinus of one side
2) Xenograft is used in the sinus on the other side of the same patient
Main outcome variables
The amount of formed bone; The amount of remained graft material
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201215049728N1
Registration date:2021-01-09, 1399/10/20
Registration timing:registered_while_recruiting
Last update:2021-01-09, 1399/10/20
Update count:0
Registration date
2021-01-09, 1399/10/20
Registrant information
Name
Mohammad taghi Chitsazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 7314
Email address
mtchitsazi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Concentrated Growth Factor (CGF) on healing outcome in maxillary sinus graft (histological examination)
Public title
The effect of a growth factor on restoration results in maxillofacial lift
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of bilateral posterior partial edentulousness or complete maxillary edentulousness
The remaining bone height between the alveolar crest and the sinus floor is less than 5mm
Exclusion criteria:
Smokers
Pregnant women
Presence of pathological symptoms, cystic lesions, acute and chronic inflammatory disease, benign and malignant tumors in the sinus
Existence of systemic diseases such as uncontrolled diabetes, cardiovascular disease, malignancy, head and neck radiotherapy
Autoimmune diseases that make soft and hard tissue repair difficult
Use of steroid drugs and immunosuppressants - bisphosphonates
Existence of untreated and periapical periodontal diseases, especially in the teeth adjacent to the sinus floor
Age
From 30 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
9
More than 1 sample in each individual
Number of samples in each individual:
2
14 maxillary sinus samples were obtained from 7 patients. To increase the validity of the study, 20% was added to the sample size, and finally 18 sinuses from 9 patients were considered.
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is random among the people referring to the Tabriz Dental School. The randomization method is simple and the unit is individual. To do this, the types of treatment are identified with code A (Growth factor) and B(Xenograft ), and then will be placed in sealed envelopes and will be stirred. Then they are randomly taken out of the bag and after observing the code, the desired treatment will be given to the right side and the other treatment will be given to the left side of the patient's mouth.
Blinding (investigator's opinion)
Single blinded
Blinding description
Samples prepared from individuals are sent as coded form to the laboratory. The examiner (histologist) has no knowledge of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tabriz University of Medical Sciences
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-12-13, 1399/09/23
Ethics committee reference number
IR.TBZMED.REC.1399.845
Health conditions studied
1
Description of health condition studied
Dental implants
ICD-10 code
Z96.5
ICD-10 code description
Presence of tooth-root and mandibular implants
Primary outcomes
1
Description
The amount of newly formed bone
Timepoint
6 months after treatment
Method of measurement
Histological specific staining (Hematoxylin and Alizarin red)
Secondary outcomes
1
Description
The remaining amount of graft material
Timepoint
6 months after treatment
Method of measurement
Histological specific staining (Hematoxylin and Alizarin red)
Intervention groups
1
Description
Intervention group 1: Concentrated growth factor (CGF) is placed in the sinus and after 6 months, a histological sample will be prepared from the osteotome site with a 2.7mm narrow terpene milling machine and will be sent to the histological laboratory for examination.
Category
Treatment - Other
2
Description
Intervention group 2: A xenograft is placed in the sinus on the other side of Navateb Pars Company and after 6 months, a histological sample from the osteotome site will be prepared with a 2.7mm narrow terpene milling machine and will be sent to the histology laboratory for examination.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences, School of Dentistry
Full name of responsible person
Mohammadtaghi Chitsazi
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mtchitsazi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadtaghi Chitsazi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mtchitsazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadtaghi Chitsazi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mtchitsazi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammadtaghi Chitsazi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mtchitsazi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available