The main aim is to compare the clinical effects of palatal grafting (Connective Tissue Graft) and Platelet Rich Fibrin in root coverage surgery
Design
The study is a double-blind split mouth clinical trial in which the patient and the evaluator in the study are blind.
Settings and conduct
This study will be conducted on patients referred to the Faculty of Dentistry, Islamic Azad University of Medical Sciences, Tehran. The surgery is performed bilaterally in each patient, on one side using fibrin rich in platelets (through centrifugation of the patient's blood) and on the other side, palatal connective tissue is taken.
Participants/Inclusion and exclusion criteria
Non-smoker and non-alcoholic; Systemically healthy; Age over 18 years; O'LEARY Index less than 20 percent; The presence of gingival erosion of Miller class 1 on the buccal surface of two non-adjacent anterior teeth of the upper and lower jaw; The depth of the probe is less than 3 mm; The amount of gingival recession is at least 2 mm; Thin periodontal biotype; The presence of attached gingiva at least 2 mm; Absence of cervical restoration in the treatment areas; No history of root coverage surgery ; No history of trauma
Comparison effect of Connective Tissue Graft (CTG) and Platelet Rich Fibrin in treatment of gingival recession.
Public title
Comparison effect of Connective Tissue Graft (CTG) and Platelet Rich Fibrin in treatment of gingival recession.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No systemic disease
Bilateral gingival recession Miller 1
Plaque index less than 20%
Exclusion criteria:
Systemic disease
No existence of bilateral gingival recession Miller 1
Poor oral hygieny
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
13
More than 1 sample in each individual
Number of samples in each individual:
2
Bilateral gingival recession
Randomization (investigator's opinion)
Randomized
Randomization description
To reduce selection bias, the priority of treatment on the right and left side and which treatment should be performed on which side of the patient
It is done with Random allocation of concealed using SNOSE (Sequentially numbered sealed opaque) envelopes, that is, sealed and numbered envelopes. (Because the envelopes are sealed, Allocational Concealment will also be done at the same time as Randomization itself.) Blocked randomization is not possible in small volumes. Therefore, the order of performing surgery on the right or left side is done by the method of numbered envelopes
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, there is no possibility of blinding the surgeon and only the evaluator during the measurements
The studied parameters do not know the method performed on the right and left side (which treatment was performed on which side).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
9th Neyestan St., Pasdaran St., Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2023-11-25, 1402/09/04
Ethics committee reference number
IR.IAU.DENTAL.REC.1402.108
Health conditions studied
1
Description of health condition studied
Gingival recession
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pocket Probing Depth
Timepoint
Day 0 & month 3 & 6
Method of measurement
William probe
2
Description
Recession Depth
Timepoint
Day 0 & month 3 & 6
Method of measurement
William probe
3
Description
Width of keratinizted gingiva
Timepoint
Day 0 & month 3 & 6
Method of measurement
William probe
4
Description
Root Coverage percent
Timepoint
Day 0 & month 3 & 6
Method of measurement
Formula
5
Description
Patient Esthetic Score
Timepoint
Day 0 & month 3 & 6
Method of measurement
Visuagal Analog Score
6
Description
Sensitivity Score
Timepoint
Day 0 & month 3 & 6
Method of measurement
Visual Analog Score
7
Description
Clinical Attachment Level
Timepoint
Day 0 & month 3 & 6
Method of measurement
William prob
8
Description
Gingival Thickness
Timepoint
Day 0 & month 3 & 6
Method of measurement
Endodontic Reamer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Platelet Rich Fibrin
Category
Treatment - Surgery
2
Description
Control group: Connective Tissue Graft
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Islamic Azad University of Medical Sciences
Full name of responsible person
Dr. Mahsa Soleimani
Street address
N.9, 9th Neyestan St., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Int.affairs@tms.iau.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahsa Soleimani
Street address
No. 9, 9th Neyestan St., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
20
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
Islamic Azad University
Full name of responsible person
Mahsa Soleimani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Netestan St., Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
dr.soleimani63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahsa Soleimani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan St., Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drsoleimani63@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mahsa Soleimani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, 9th Neyestan St., Pasdaran St
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drsoleimani63@gmail.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 data related to results and outcomes will be published.
When the data will become available and for how long
At least 1 month after the end of the study
To whom data/document is available
People with relevant academic education
Under which criteria data/document could be used
Only the data related to the obtained results will be accessible.
From where data/document is obtainable
drsoleimani63@gmail.com
What processes are involved for a request to access data/document