Protocol summary

Study aim
Study the effect of plasma rich in growth factors with tunnel technique in the treatment of gingival recession
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 bilateral gingival recession. Sampling was done randomly and for each treatment group, 10 samples and a total of 20 samples were considered. Participants and outcome measurer of this study are blind (double-blind).
Participants/Inclusion and exclusion criteria
Selection criteria: At least 18 years old, The presence of single-ended gingival recession, alive teeth (The confounding factor is as low as possible), without filling or bleeding of probing, Keratinized gum width greater than 2mm, Signature of consent form; exclusion criteria: Pregnancy, Coagulation problems, Any local or systemic disease that has a contraindication to periodontal treatment. Active infectious disease, smoking, the Fernum stretch in the surgical area, Use of traumatic brushing techniques.
Intervention groups
1.Debridement with applying PRGF, 2.Debridement alone
Main outcome variables
Clinical parameters include keratinized tissue width, clinical attachment level, clinical probing depth, the vertical depth of the gingival recession, recession width, CEJ to MGJ distance, root coverage percentage, healing index, esthetic visual analogue scale, and pain visual analogue scale.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100427003813N9
Registration date: 2018-10-02, 1397/07/10
Registration timing: retrospective

Last update: 2018-10-02, 1397/07/10
Update count: 0
Registration date
2018-10-02, 1397/07/10
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
2018-04-21, 1397/02/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of plasma rich in growth factors with tunnel technique in the treatment of gingival recession
Public title
Study of the effect of plasma rich in growth factors with tunnel technique in the treatment of gingival recession
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old The presence of single-ended gingival recession of the miller class I / II with a depth of 2 mm = <CEG of the anterior and permoral teeth alive teeth, without filling or bleeding of probing (The confounding factor is as low as possible) Ability to maintain proper sanitation(O'LEARY plaque score<=20%) Keratinized gum width greater than 2mm Gingival thickness 0.5 = <2mm apical gum margin Signature of consent form
Exclusion criteria:
Pregnancy Coagulation problems Use medications of Platelet Interaction (NSAIDs) Use of drugs which interact with wound healing Any local or systemic disease that has a contraindication to periodontal treatment. Allergy to surgical materials (The confounding factor is as low as possible) Active infectious disease (hepatitis, tuberculosis and AIDS) smoking Fernum stretch in the surgical area Use of traumatic brushing techniques, toothbrushes and abrasive toothbrushes Use of removable prosthesis plaques in the desired area
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 10
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
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
2018-02-26, 1396/12/07
Ethics committee reference number
MUBABOL.HRI.REC.1396.210

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
Keratinized tissue width
Timepoint
before surgery, 6 weeks and 3 months after surgery
Method of measurement
with periodontal probe

2

Description
Clinical attachment level
Timepoint
before surgery, 6 weeks and 3 months after surgery
Method of measurement
with periodontal probe

3

Description
Recession width
Timepoint
before surgery, 2 weeks and 3 months after surgery
Method of measurement
with periodontal probe

4

Description
Vertical Recession Depth
Timepoint
before surgery, 2 weeks and 3 months after surgery
Method of measurement
with periodontal probe

5

Description
Healing index
Timepoint
1 and 3 days 1 week and 1 months after surgery
Method of measurement
with healing index (HI) based on Landry index

6

Description
Clinical Probing Depth
Timepoint
before surgery, 6 weeks, 3 months after surgery
Method of measurement
with periodontal probe

7

Description
Esthetic Visual Analogue scale
Timepoint
before surgery, 6 weeks, 3 months after surgery
Method of measurement
with Visual analogue scale

8

Description
Pain Visual Analogue scale
Timepoint
1, 3 and 7 days after surgery
Method of measurement
whit Visual analogue scale

9

Description
Distance from cementoenamel junction (CEJ) to mucogingival junction (MGJ or MGJL) in the middle of the buccal surface of the tooth
Timepoint
before surgery, 6 weeks, 3 months after surgery
Method of measurement
with periodontal probe

10

Description
Percentage of Root Coverage
Timepoint
3 months after surgery
Method of measurement
[(Vertical Recession Depth before surgery - Vertical Recession Depth after Surgery)/ divided Vertical Recession Depth before surgery]*100

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: open flap debridement with plasma-rich growth factor
Category
Treatment - Surgery

2

Description
Control group: Open flap debridement
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Periodontology departmet of Babol dental faculty
Full name of responsible person
Fatemeh Ahrari
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3220 7918
Email
Dr_mahtab_777@yahoo.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
Associated professer
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
Associated professer
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
Fatemeh Ahrari
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
Dr_mahtab_777@yahoo.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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