One of the most important esthetics problems in periodontal plastic surgery is the ability to reconstruct papilla in anterior maxilla. Absence of papilla with dark spaces creates “Dark Triangle” which is an important aspect for the clinician to decide whether to treat or not .This problem will cause difficulties such as esthetics, food retention and phonetics. In most articles using sub-epithelial connective tissue with different incisions is recommended. Therefore in this research sub-epithelial connective tissue graft with papilla preservation technique and semilunar incision is used. Ten patients were chosen randomly according to inclusion criteria (above 18 years old; no systemic disease,..) and exclusion criteria (pregnancy; cigarette smoking,…). If there were more patients the number of samples would be increased in each group. Surgical sites are divided into two groups randomly (five patients in each group). Intervention group 1: primary incision is semilunar 3 mm below MGJ, secondary incision is sulcular. Full thickness flap is reflected in semilunar incision. Intervention group 2: papilla preservation technique is used .In cases of short papilla width for a better vascularization the horizontal incision is placed on labial portion. Before surgery the size of papilla is measured by Nordland and Tarnow index and is followed after 3 and 6 month .At the end the papilla is measured apicocoronally and mesiodistally .Wound repair Index and VAS esthetic index are analyzed as well.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404071760N34
Registration date:2014-05-04, 1393/02/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-05-04, 1393/02/14
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
Vice Chancellor for 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 Papilla preservation technique and pouch& tunnel with subepithelial connective tissue graft in dark triangle treatment
Public title
The comparison of Papilla preservation technique and pouch& tunnel with subepithelial connective tissue graft in dark triangle treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: existence the dark triangle anterior max; Tarnow all black triangles classified under group I, II; the selected teeth vital and no bleeding after probing; people over 18 years old; ability to maintain good oral hygiene (Oleary plaque score <20%); without stretching the frenum
Exclusion criteria: pregnancy; history of blood clotting problems, and hematologic; interfere with the healing agents (corticosteroids, anticancer); drugs interfering with platelet function (NSAIDS); smoking; any local or systemic disease with surgical procedures to prohibit administration; traumatic methods of brushing, toothbrush, toothpaste abrasives or harsh; long-term use of antibiotics in the previous quarter (more than 2 weeks); with known allergies to materials used in surgery; active infectious diseases (tuberculosis, hepatitis, HIV); use of drugs can lead to gingival enlargement.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
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 dark Triangle
Timepoint
Before surgery and three and six months after surgery
Method of measurement
Indexed Nordland and Tarnow
Secondary outcomes
1
Description
APico - coronal Papilla dimension
Timepoint
Before surgery and three and six months after surgery
Method of measurement
Mm
2
Description
MOD Papilla dimension
Timepoint
Before surgery and three and six months after surgery
Method of measurement
Mm
3
Description
Healing
Timepoint
Before surgery and three and six months after surgery
Method of measurement
Healing index
4
Description
Beauty
Timepoint
Before surgery and three and six months after surgery
Method of measurement
Indexed beauty VAS
Intervention groups
1
Description
Intervention group 1:
The first incision is semilunar 3 mm below MGJ .The second incision is sulcular .In semilunar incision flap is reflected full thickness .SCTG is taken from the palate in premolars site and is sutured with a 4-0 silk suture (Manufacturer: Ethicon, Iran) that has been previously passed from the papilla .Periodontal pack(non-eugenol, GC, USA) is placed both on donor and recipient site .For all patients CHX 0.12% is prescribed for two weeks twice a day for 30 seconds each time .Systemic antibiotics(Penicillin vk 500 mg qid) is prescribed for one week .Pack and suture are removed after two weeks.
Category
Treatment - Surgery
2
Description
Intervention group 2:
Papilla preservation technique :papilla preservation incision is used and in cases where the width of papilla is short for better vascularization the horizontal incision is placed on labial .SCTG is taken from the palate in premolars site and is sutured in papilla with 4-0 silk suture(Ethicon, Iran)There after the horizontal incision is sutured with the same suture .Periodontal pack(Non-eugenol, GC, USA)is placed both in donor and recipient site .CHX 0.12 % is prescribed for all patients for two weeks twice per day for 30 seconds each time .Systemic antibiotics (Penicillin vk 500 mg qid) is prescribed for one week .Pack and suture are removed after two weeks.
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. Morteza Rahimi Rad
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 colleges of Babol
Full name of responsible person
Dr. Morteza Rahimi Rad
Position
Post graduate student of periodontology
Other areas of specialty/work
Street address
Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
mortezadds@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental colleges of Babol
Full name of responsible person
Dr. Niloofar Jenabiyan
Position
Periodontology
Other areas of specialty/work
Street address
Dental colleges of Babol, Babol University of Medical Sciences, Ganjafroz Avenue
City
Babol
Postal code
Phone
+98 11 1229 1408
Fax
Email
njenabian@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol- Babol University of Medical Sciences, Fatemehzahra Infertility & Reproductive Health Research
Full name of responsible person
Nargess Gholizadeh Pasha
Position
MSc
Other areas of specialty/work
Street address
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)