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Clinical Comparison Root coverage in Coronally Advanced Flap Technique with free Connective Tissue Graft and Platelet-Rich Fibrin in Patients with Root covrage candidates

Protocol summary

Study aim
Clinical comparison and root coverage in Coronally Advanced flap technique with free connective tissue graft and Platelet-Rich Fibrin
Design
Non-control group randomized, double-blind, placebo-controlled clinical trial
Settings and conduct
Department of Periodontology and Implantation, Faculty of Dentistry, Isfahan University of Medical Sciences
Participants/Inclusion and exclusion criteria
Patients under study were selected from the periodontology and implant department of Isfahan University of Medical Sciences, between the ages of 18 and 65 years, requiring gingival recession treatments in each of the incisors and mandibular incisors and premolars. Provided that the buccal level of analysis is classified in groups of 1 or 2, Miller does not rot or repair in the tooth in question and at least has an area requiring root coverage. Patients will be included in the study if they so choose.Patients with specific systemic conditions affecting recovery such as uncontrolled diabetes, immunodeficiency diseases, systemic or localized bone disease, history of alcohol use, addiction, smoking (currently), pregnancy, people taking immunosuppressive or anticoagulant drugs, Patients with poor cooperation and untreated active periodontal disease specimens and those who were unable to maintain oral health or who did not wish to maintain oral health were excluded. Also, in case of any repair or caries on buccal surface of the desired teeth or pathological abnormality in the teeth, the samples are excluded.
Intervention groups
Platelet-rich fibrin group derived from patient's blood and used for root covrage during surgery. The other group consists of connective tissue graft taken from the patient's palate and used for root covrage surgery.
Main outcome variables
PD, CAL, WKT, RH, WH, TB

General information

Reason for update
Acronym
PRF
IRCT registration information
IRCT registration number: IRCT20200329046889N1
Registration date: 2020-06-28, 1399/04/08
Registration timing: registered_while_recruiting

Last update: 2020-06-28, 1399/04/08
Update count: 0
Registration date
2020-06-28, 1399/04/08
Registrant information
Name
fatemeh ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5437 5699
Email address
f.ghorbani69@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-12, 1399/03/23
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Comparison Root coverage in Coronally Advanced Flap Technique with free Connective Tissue Graft and Platelet-Rich Fibrin in Patients with Root covrage candidates
Public title
Effect of platelet-rich fibrin on root surface coverage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Referrers to the periodontology and implant department of the School of Dentistry of Isfahan University of Medical Sciences, aged 18-60 years, who are seeking treatment for gingival recession in each of the incisors and maxillary or mandibular premolars, are selected. The type of Miller gingival recession is 1 or 2 and Teeth should not be decayed or filled and at least has two areas that require root coverage.
Exclusion criteria:
Patients with specific systemic conditions affecting recovery such as uncontrolled diabetes, immunodeficiency diseases, systemic or localized bone disease, history of alcohol use, addiction, smoking (currently), pregnancy, people taking immunosuppressive or anticoagulant drugs, Patients with poor cooperation and untreated active periodontal disease specimens and those who were unable to maintain oral hygiene or who did not wish to maintain oral hygiene were excluded. Also, in case of any repair or caries on buccal surface of the desired teeth or pathological mobility in the teeth, the samples are excluded.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, surgeons and patients are aware of the type of treatment due to the use of connective tissue or PRF, which is taken from the patient's blood, but the outcome assessor and the analyst are not aware.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of isfahan University of Medical Sciences
Street address
Azadi Square ,Hezarjarib st.
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2020-06-10, 1399/03/21
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.128

Health conditions studied

1

Description of health condition studied
Gingival recession
ICD-10 code
K06.0
ICD-10 code description
Gingival recession (generalized)(localized)(post infective)(post-operative)

Primary outcomes

1

Description
Recession Height
Timepoint
3 and 6 month
Method of measurement
Michigan Probe

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The platelet-rich fibrin group is prepared from the patient's blood during the centrifugation process within 12 minutes
Category
Treatment - Surgery

2

Description
Intervention group: Connective tissue grafting group, which is prepared from the palate of each patient
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Periodontology and Implantation, Faculty of Dentistry, Isfahan University of Medical S
Full name of responsible person
Fatemeh Ghorbani
Street address
Barazandeh street
City
Esfahan
Province
Isfehan
Postal code
8193976468
Phone
+98 31 5437 5699
Email
f.ghorbani69@dnt.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohamad tavakoli
Street address
Barazandeh
City
Esfahan
Province
Isfehan
Postal code
8193976468
Phone
+98 31 3792 5570
Email
tavakoli@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Ghorbani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Barazandeh
City
Esfahahn
Province
Isfehan
Postal code
8193976468
Phone
009854375699
Email
f.ghorbani69@dnt.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatameh Ghorbani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Barazande
City
Esfhan
Province
Isfehan
Postal code
8193976468
Phone
+98 31 5437 5699
Email
f.ghorbani69@dnt.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatameh Ghorbani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Barazande
City
Esfahan
Province
Isfehan
Postal code
8193976468
Phone
00980315699
Email
f.ghorbani69@dnt.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Lack of time and budget
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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