Recession of marginal gingival causes different esthetic and functional problems. Free gingival graft can increase the width of attached gingival. There are significantly different vascular distributions in gingival regional districts, so conventional free palatal graft modified with the involvement of marginal gingival and papillary tissue ( described as the gingival unit ) may have an uncommon capacity for per fusion and survival on the exposed root surfaces. The aim of this study is to clinically evaluate the treatment of gingival recession by using gingival unit grafts compared with conventional palatal grafts. In this double-blind study 9 patients will be included based on inclusion criteria and surgical sites divided into two groups randomly in every patient.
Case group (free gingival unit graft): the donor gingival unit graft was dissected from the palatal aspect of the maxillary premolars.
Control group ( conventional free gingival graft): the donor palatal graft was harvested from the palate corresponding to the premolar area but ‡2 mm away from the gingival
margin.
Landry index, pain index, esthetic index, root coverage percent will be checked 1, 3 and 6 months after surgery and the distance between CEJ and gingival sulcus will be checked 3 and 6 months after surgery. Statistical analyses will be performed using SPSS software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201403061760N33
Registration date:2014-04-27, 1393/02/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-27, 1393/02/07
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2014-03-11, 1392/12/20
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Free gingival unit graft and free gingival graft for the Treatment of Gingival Recession
Public title
The Comparison of Free gingival unit graft and free gingival graft for the Treatment of Gingival Recession
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: there is a single two-way analysis of facial tissue depth of 2mm ≤ X CEJ on anterior teeth or premolars; putting all subgroup analyzes of Miller class I / II; selected teeth without root fillings and no bleeding after probing; people over 18 years of age; ability to maintain good oral hygiene (% 20 O'Leary plaque score≤); sufficient depth of vestibule. Exclusion criteria: pregnancy; interfere with the healing agents (corticosteroids, anti-cancer) or medicines that may lead to gingival enlargement; smoking; administration has banned any local or systemic disease, periodontal surgery; traumatic brushing techniques, brushing hard or abrasive toothpastes; history of periodontal surgery in the area in the past 2 years; the use of removable prosthodontic or orthodontic appliances in the area; known allergies to materials used in surgery.
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
9
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of Babol University of Medical sciences
Street address
Babol University of Medical sciences, Ganjafroz Avenue
City
Babol
Postal code
Approval date
2014-03-08, 1392/12/17
Ethics committee reference number
30/3810/پ
Health conditions studied
1
Description of health condition studied
Gingival Recession
ICD-10 code
K06.0
ICD-10 code description
Gingival Recession
Primary outcomes
1
Description
Treatment of Gingival Recession
Timepoint
Six months after surgery
Method of measurement
clinical
Secondary outcomes
1
Description
Healing
Timepoint
One, three and six months after surgery
Method of measurement
Indexed repair Landry
2
Description
Pain relief after surgery
Timepoint
One, three and six months after surgery
Method of measurement
pain Index (VAS)
3
Description
esthetic
Timepoint
One, three and six months after surgery
Method of measurement
Esthetic index (VAS)
4
Description
Percentage of root coverage (RC)
Timepoint
One, three and six months after surgery
Method of measurement
Clinical
5
Description
Clinical Attachment Level ( CAL )
Timepoint
Three and six months after surgery
Method of measurement
Mm
Intervention groups
1
Description
Case group (free gingival unit graft): the donor gingival unit graft was dissected from the palatal aspect of the maxillary premolars.
Care will be taken to obtain a graft thickness of 1 mm. The graft will be
then contoured, adapted, sutured into position at the level or coronal to the CEJ and the donor site will be sutured with 4-0 VICRYL suture too.
Both donor and recipient site will be covered with periodontal dressing. All of the patients will be devised to rinse once daily with 0.2% of Chlorhexidine for 3 weeks. Systemic antibiotic (Amoxicillin 500mg tid) will be administered for 1 week and sutures will be off after 10 days.
Category
Treatment - Surgery
2
Description
Control group ( conventional free gingival graft): the donor palatal graft was harvested from the palate corresponding to the premolar area but ‡2 mm away from the gingival
margin. Care will be taken to obtain a graft thickness of 1 mm. The graft will be
then contoured, adapted, sutured into position at the level or coronal to the CEJ and the donor site will be sutured with 4-0 VICRYL suture too.
Both donor and recipient site will be covered with periodontal dressing. All of the patients will be devised to rinse once daily with 0.2% of Chlorhexidine for 3 weeks. Systemic antibiotic (Amoxicillin 500mg tid) will be administered for 1 week and sutures will be off after 10 days.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental colleges of Babol, Babol University of Medical Sciences,
Full name of responsible person
Dr. Mohadese Yazdan Panah
Street address
Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali Bijani
Street address
Vice Chancellor for Research and Technology, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Babol 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
Dental School, Babol University of Medical Sciences
Full name of responsible person
Dr. Mohadese Yazdan Panah
Position
Post graduate student of periodontology
Other areas of specialty/work
Street address
Dental School, Babol - Babol University of Medical Sciences- Gangafroz Avenue
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
mohadese.yazdanpanah@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School, Babol University of Medical Sciences
Full name of responsible person
Dr. Niloofar Jenabiyan
Position
Periodontology
Other areas of specialty/work
Street address
Dental School, Babol - Babol University of Medical Sciences- Gangafroz Avenue
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
n.jenabian@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Infertility & Reproductive Health Research Center, Babol University of Medical Sciences
Full name of responsible person
Nargess Gholizadeh Pasha
Position
Other areas of specialty/work
Street address
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)