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Evaluation of the effect of plasma rich in growth factors (PRGF) with sub- epithelial connective tissue graft via semilunar technique in dark triangle treatment

Protocol summary

Study aim
Evaluation of the effect of plasma rich in growth factors (PRGF) with sub- epithelial connective tissue graft via semilunar technique in dark triangle treatment
Design
Clinical trials with a control group, with parallel groups, double-blind, randomized. Surgical areas are randomly divided into two groups by coin throwing method.
Settings and conduct
The study will be conducted on patients referring to the periodontics department of Babol Dental School, which has a dark triangle. Sampling will be done randomly and for each treatment group, 16 samples and a total of 32 region will be considered. Participants and outcome measurer of this study will be blind (double-blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 18 years, At least one region of an absence of papilla should be sub-type I, II of Tarnow's classification and in the Anterior Maxilla, Ability to maintain proper good oral hygiene (O'LEARY plaque score<=20%), Signature of a consent form. Exclusion criteria: Pregnancy, Coagulation problems, Medications interfering with Platelet function (NSAIDs), Medications interfering with wound healing (Corticosteroid, anti-cancer), Any systemic or local disease that has a contraindication in periodontal treatment, Allergic reaction to materials used in surgery, Active infectious disease (hepatitis, tuberculosis and AIDS), smoking, Frenum stretch in the surgical area, Orthodontic patients, The use of medications that are well-established causes of gingival enlargement.
Intervention groups
Intervention group: Connective tissue graft with PRGF via Semilunar technique
Main outcome variables
Healing index, probing pocket depth (PPD), Esthetic Visual Analogue scale, Postoperative pain, Bleeding on probing (BOP) and Mesiodistal and Apicocoronal distance of the dark triangle.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100427003813N11
Registration date: 2020-03-29, 1399/01/10
Registration timing: registered_while_recruiting

Last update: 2020-03-29, 1399/01/10
Update count: 0
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Niloofar Jenabian
Name of organization / entity
Dental Faculty of University of Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 1408
Email address
n.jenabian@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2020-07-31, 1399/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of plasma rich in growth factors (PRGF) with sub- epithelial connective tissue graft via semilunar technique in dark triangle treatment
Public title
Evaluation of the effect of plasma rich in growth factors (PRGF) with sub- epithelial connective tissue graft via semilunar technique in dark triangle treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years At least one region of an absence of papilla should be sub-type I, II of Tarnow's classification and in the Anterior Maxilla Ability to maintain proper good oral hygiene (O'LEARY plaque score<=20%) Signature of consent form
Exclusion criteria:
Pregnancy Coagulation problems Medications interfering with Platelet function (NSAIDs) Medications interfering with wound healing (Corticosteroid, anti-cancer) Any systemic or local disease that has a contraindication in periodontal treatment Allergic reaction to materials used in surgery Active infectious disease (hepatitis, tuberculosis and AIDS) smoking Frenum stretch in the surgical area Orthodontic patients The use of medications that are well-established causes of gingival enlargement Use of traumatic tooth brushing, abrasive tooth brushes Use of antibiotics in the past 3 months (for 2 weeks) Periodontal disease
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 16
More than 1 sample in each individual
Number of samples in each individual: 2
Each side of the mouth is considered as a sample.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be enter the study according to inclusion and exclusion criteria. Surgical areas are randomly divided into two groups by coin throwing method.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are unaware of which treatment group they are. The outcome measurer is different from whom that cures patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Babol univercity of medical science
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2020-01-11, 1398/10/21
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.266

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
Healing index
Timepoint
On the day of surgery, 14, 30, 90, and 180 days after the surgery
Method of measurement
with healing index (HI) based on Landry index

2

Description
probing pocket depth (PPD)
Timepoint
On the day of surgery, 14, 30, 90, and 180 days after the surgery
Method of measurement
using a standardized periodontal probe

3

Description
Esthetic Visual Analogue scale
Timepoint
On the day of surgery, 14, 30, 90, and 180 days after the surgery
Method of measurement
with Visual analogue scale

4

Description
Postoperative pain
Timepoint
On the day of surgery, 14, 30, 90, and 180 days after the surgery
Method of measurement
with Visual analogue scale

5

Description
Bleeding on probing (BOP)
Timepoint
On the day of surgery, 14, 30, 90, and 180 days after the surgery
Method of measurement
using a standardized periodontal probe

6

Description
Mesiodistal distance of dark triangle
Timepoint
On the day of surgery, 14, 30, 90, and 180 days after the surgery
Method of measurement
using a standardized periodontal probe

7

Description
َApicocoronal distance of the dark triangle
Timepoint
On the day of surgery, 14, 30, 90, and 180 days after the surgery
Method of measurement
using a standardized periodontal probe

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Connective tissue graft with PRGF via Semilunar technique
Category
Treatment - Surgery

2

Description
Control group: Connective tissue graft via Semilunar technique
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Periodontology departmet of Babol dental faculty
Full name of responsible person
mahsa shirzad
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
mahsaaashirzaddd@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Niloofar Jenabian
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
n.jenabian@mubabol.ac.ir
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 Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Niloofar Jenabian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
n.jenabian@mubabol.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Niloofar Jenabian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
n.jenabian@mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
mahsa shirzadd
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
mahsaaashirzaddd@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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