Comparison of increasing the width and thickness of keratinized gingiva in two methods of connective tissue graft and graft by composition of collagen and rich plasma in patients who are candidate for gingival grafts
The purpose of this study is to compare clinically and histologically two methods of gingival grafts: the connective tissue graft and combination of Stypro plus platelet rich plasma plus platelet rich fibrin in increasing the width and thickness of keratinized gingiva in patients who are candidate for gingival grafts. 8 patients among patients of periodontology department of Shiraz dental school will be selected who have inadequate width of keratinized gingiva(2 mm or less) and inadequate thickness of keratinized gingiva(1 mm or less) bilaterally at buccal of one root teeth. Pregnancy; coagulation disorders; diabetes; cardiovascular disorders; hypertension; radiotherapy; cancer and other systemic disorders which influence the keratinization were the exclusion criterias. In the first surgery at one side we will perform graft of combination of Stypro plus platelet rich plasma plus platelet rich fibrin which will maintained in their bed by acrylic stent. In second surgery at contalaterl we will perform connective tissue graft. Measurements of width and thickness and mobility of the graft on the bed will perform 1, 2, 3 months later. At the end of second month punch biopsy will be performed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202018723N1
Registration date:2012-04-22, 1391/02/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-22, 1391/02/03
Registrant information
Name
Samira Esmailzadeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 936 888 5061
Email address
esmaeilzad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of increasing the width and thickness of keratinized gingiva in two methods of connective tissue graft and graft by composition of collagen and rich plasma in patients who are candidate for gingival grafts
Public title
Comparison of two methods of graft in patients who are candidate for gingival grafts
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:patients with inadequate width(2 mm or less) and thickness(1 mm or less) of keratinized gingiva bilaterally at buccal in one root teeth;without muscle attachment; with 5 to 7 mm depth of the vestible; adjacent teeth have enough width and thickness of keratinized gingiva.
exclusion criteria:pregnancy;clotting disorders;diabete;cardiovascular problems;hypertension;radiotherapy;cancer;other systemic disorders
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
8
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Fars University of Medical sciences
Street address
Zand Ave, Shiraz
City
Shiraz
Postal code
1978-71345
Approval date
2012-01-21, 1390/11/01
Ethics committee reference number
CT_90_5917
Health conditions studied
1
Description of health condition studied
Inadequate width and thickness of keratinized gingiva
ICD-10 code
k06
ICD-10 code description
Gingival recession
Primary outcomes
1
Description
width of keratinized gingiva
Timepoint
1,2 and 3 months after intervention
Method of measurement
rolling and logul solution
2
Description
thickness of keratinized gingiva
Timepoint
1,2 and 3 months after intervention
Method of measurement
with endodontic files
Secondary outcomes
1
Description
pain
Timepoint
everyday until one week after surgery
Method of measurement
with VAS
Intervention groups
1
Description
intervention group: surgery of graft of stypro plus platelet rich plasma plus platelet rich fibrin
Category
Treatment - Other
2
Description
control group: surgery of gingival graft (connective tissue graft)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontology Department of Shiraz DentaL School
Full name of responsible person
Samira Esmailzadeh
Street address
Ghomabad
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fars University of Medical Sciences
Full name of responsible person
Dr.Gholamreza Hatam
Street address
Zand Ave, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fars University of Medical Sciences
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
Fars University of Medical Sciences
Full name of responsible person
Samira Esmailzadeh
Position
resident
Other areas of specialty/work
Street address
Shiraz Dental School, Ghomabad Ave
City
Shiraz
Postal code
Phone
+98 936 888 5061
Fax
Email
esmaeilzad@sums.ac.irsamira.esmailzadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Dental School
Full name of responsible person
Dr.Hengame Khosropanah, Dr.Ali Dehghani Najhvani
Position
periodontology specialist-pathology specialist
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Phone
+98 71 1626 3194
Fax
Email
khosropanah979@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Samira Esmailzadeh
Position
resident
Other areas of specialty/work
Street address
Shiraz Dental School
City
Shiraz
Postal code
Phone
+98 936 888 5061
Fax
Email
esmaeilzad@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)