The goal of this study is to evaluate the effect of Platelet Rich Plasma in wound healing of periodontological surgeries. A total 20 patients, aged 20-45 years old, who need bilateral F.G.G in Periodontics department of Babol Dental School. Each side of the mouth will be randomly assigned to be treated as routine free gingival grafting technique alone or receive additional PRP on and around the wound as well as routine technique. All the grafts will be harvested by mucotom (A. DOPPELER made in SWISS) to have the same size (thickness 1.5 mm, width 9 mm, length 15 mm). All patients use stent to eliminate local factors. Palatal anesthesia would be achieved by one dental carpool containing 2% Lidocaine and 1/100000 Epinephrine. Wound healing would be evaluated by 3 different investigators 2, 4, 7, and 14 days and 2 months after the surgery according to healing scales, pain intensity and tissue thickness.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138812093451N1
Registration date:2011-01-02, 1389/10/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-02, 1389/10/12
Registrant information
Name
Mahmood Khosravi samani
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 1408
Email address
m.khosravi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Dental Material Investigation Center, Babol University of Medical Sciences
Expected recruitment start date
2010-02-19, 1388/11/30
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The clinical evaluation of Platelet-Rich Plasma effects on Free Gingival Graft's donor site wound healing
Public title
The clinical evaluation of Platelet-Rich Plasma effects on Free Gingival Graft's donor site wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20 to 45 years old, need to bilateral (left and right) Free Gingival Graft for loss of attached gingiva or high frenum or shalloe vestibular depth, Recipient site has to be about 2 cm
Exclusion criteria: presence of Systemic diseases or life style elements that impact on healing process such as diabetes mellitus, Immune system diseases, history of alcohol use, healing disorders, addiction, smoking or no cooperation, abnormal CBC or blooding time
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University Of Medical Scienses Ethics committee
Street address
Babol University Of Medical Scienses
City
Babol
Postal code
4713915697
Approval date
2010-04-20, 1389/01/31
Ethics committee reference number
30791/ژ/پ
Health conditions studied
1
Description of health condition studied
wound healing
ICD-10 code
S00.5
ICD-10 code description
Superficial injury of lip and oral cavity
Primary outcomes
1
Description
wound healing
Timepoint
2,4,7,14 days and second month after the surgery
Method of measurement
landry healing scale
2
Description
Pain
Timepoint
days 2, 4, 7, 14 after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
tissue thickness
Timepoint
before intervention and 2 months after surgery
Method of measurement
with periodontal probe and in milimeter
Intervention groups
1
Description
using growth factors (autogenous, 0.5 cc): injected around the wound by insulin syringe
Category
Treatment - Drugs
2
Description
control group normal healing process without growth factor application.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University Of Medical Scienses
Full name of responsible person
Bardia Vadiati
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University Of Medical Scienses, Dental Material Center
Full name of responsible person
Dr.Abasi
Street address
Babol University Of Medical Scienses, Ganjafrooz St.
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University Of Medical Scienses, Dental Material Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University Of Medical Scienses
Full name of responsible person
Bardia Vadiati
Position
Post doctoral student of Periodontology
Other areas of specialty/work
Street address
Babol University Of Medical Scienses
City
Babol
Postal code
Phone
+98 11 1222 7667
Fax
Email
dr.bardia_vad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University Of Medical Scienses
Full name of responsible person
Bardia Vadiati
Position
Post doctoral student of Periodontology
Other areas of specialty/work
Street address
Babol University Of Medical Scienses
City
Babol
Postal code
Phone
+98 11 1222 7667
Fax
Email
dr.bardia_vad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University Of Medical Scienses
Full name of responsible person
Bardia Vadiati
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)