In a double blinded clinical trial using split-mouth design twelve periodontally healthy patients, aged over 18 years with lack of adequate attached gingiva on at least two sites in the mandible are included in the study.
Patients with any systemic disease or condition affecting wound healing such as diabetes; Use of immunosuppressive medications; Current or former smokers; Inadequate oral hygiene are excluded from the study.
Subsequent to recipient site preparation, a standardized 10*15 mm template is used to harvest a graft from premolar and first molar area of the hard palate and is fixed in the recipient site.
On the day of surgery and 2 days after surgery, on the test site 1ml of the gel containing 4,000 IU ml-1 Erythropoietin and on the donor site, 2ml gel with out Erythropoietin is applied on the wound.
Then the wound sites are covered with a foil and the coe-pak is placed over them.
Clinical examinations
Epithelialization
A 3% H2O2 was utilized to evaluate the wound epithelialization rate on days 7, 14, 21, 28 after surgery. The results are reported as 0,1/3,2/3, 3/3, for each wound site.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201278830N1
Registration date:2016-10-22, 1395/08/01
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-10-22, 1395/08/01
Registrant information
Name
Siamak Yaghobee
Name of organization / entity
Faculty of Dentistry, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8875 3510
Email address
yaghobee@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Eeffect of Topical Erythropoietin on Palatal Wound Healing Subsequent to Free Gingival Graft in patients with insufficient keratinized gingiva
Public title
Effects of erythropoietin in palatal wound healing
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patients with age over 18 years; with lack of adequate attached gingiva on at least two sites in the mandible
Exclusion Criteria:
Patients with any systemic disease or condition affecting wound healing such as diabetes; Use of immunosuppressive medications; Current or former smokers; Poor compliance; Inadequate oral hygiene
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tehran University of Medical Science
Street address
North Karegar Street
City
Tehran
Postal code
14399-55991
Approval date
2014-11-23, 1393/09/02
Ethics committee reference number
9011213001-119225
Health conditions studied
1
Description of health condition studied
palatal wound
ICD-10 code
S01.5
ICD-10 code description
Open wound of lip and oral cavity
Primary outcomes
1
Description
Epithelialization
Timepoint
on days 7, 14 , 21 and 28
Method of measurement
Hydrogen Peroxide 3% application
Secondary outcomes
1
Description
Inflammation
Timepoint
on days 7,14,21 and 28
Method of measurement
direct observation of the region, also photographs taken from test and control areas are prepared to be observed by three periodontists
Intervention groups
1
Description
Control group:
A 10*15 mm template is used to harvest a graft from premolar and first molar area of the hard palate and is fixed in the recipient site.
In control site: After bleeding control in the donor site, the day of surgery and 2 days after surgery 1ml of the hydroxy ethyl cellulose without Erythropoietin is applied on the wound site.
Then the wound sites are covered with a foil and the periodontal pack (coe pak, GC America) is placed over them.
Category
Treatment - Drugs
2
Description
Intervention group: A 10*15 mm template is used to harvest a graft from premolar and first molar area of the hard palate and is fixed in the recipient site.
After bleeding control in the donor site, the day of surgery and 2 days after surgery 1ml of the hydroxy ethyl cellulose gel containing 4,000 IU ml-1Erythropoietin (pooyesh daroo) is applied on the wound site.
Then the wound sites are covered with a foil and the periodontal pack (coe pak, GC America) is placed over them.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical sciences,Dental faculty,Department of Periodontology
Full name of responsible person
Siamak Yaghobee
Street address
North Karegar
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Affairs, Tehran University of Medical Science
Full name of responsible person
Professor Amirreza Rokn
Street address
North karegar Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Affairs, Tehran University of Medical Science
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
Tehran University of Medical Sciences
Full name of responsible person
Siamak Yaghobee
Position
DDS,Periodontist and Implantologist
Other areas of specialty/work
Street address
North Amirabad 14399-55991
City
Tehran
Postal code
Phone
+98 21 8835 1170
Fax
Email
ninarouzmeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Siamak Yaghobee
Position
DDS- Periodontist and Implantologist
Other areas of specialty/work
Street address
North Amirabad Street, Post code: 14399-55991, Tehran, Iran,
City
Tehran
Postal code
Phone
+98 21 8835 1170
Fax
Email
yaghobee@tums.ac.irninarouzmeh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nina Rouzmeh
Position
DDS,Periodontist
Other areas of specialty/work
Street address
North Amirabad, Post Code: 14399-55991
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)