The aim of the present study will to examine the clinical performance of the connective tissue graft associated with coronally advanced flap (CAF) versus the vestibular incision subperiosteal tunnel access (VISTA).
Design
The present study will design as a single center, randomized, double blind, parallel arm clinical trial of 6 months in duration
Settings and conduct
The patients will be randomly assigned to one of the study groups with computer generated randomization list by another investigator.The random allocation sequence will hand to the investigator who performed all of the surgical procedures on the day of surgery.
Participants/Inclusion and exclusion criteria
Study population include 24 healthy nonsmoking patients (12 in each group) with grade I or II Miller gingival recession. All of the patients are requeste treatment for aesthetic reasons and/or dentin hypersensitivity of exposed roots.
Inclusion criteria to study: multiple gingival recession in anterior region of mandible; systemically healthy with no contraindications for periodontal surgery; presence of a minimum of two adjacent periodontal recessions of Miller Class I or II; aged between 18to 65; no need for orthodontic treatment; no caries or restorations on desired teeth.
Exclusion criteria of study: systemic conditions or diseases affecting periodontal health such as uncontrolled diabetes, immunodeficiency diseases and local or systemic bone disease; pregnancy or lactation; substance abuse, smoking; use of immunosuppressive or anticoagulant drugs.
At baseline and at 3 and 6 months post-surgically, the following measurements will record for each treated site: pocket probing depth; recession height; recession width; keratinized tissue width; clinical attachment level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200804048305N1
Registration date:2020-09-01, 1399/06/11
Registration timing:retrospective
Last update:2020-09-01, 1399/06/11
Update count:0
Registration date
2020-09-01, 1399/06/11
Registrant information
Name
Zohreh Afshari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5570
Email address
z.afshar90@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-06, 1399/05/16
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of root coverage with connective tissue graft associated with coronally advanced flap or vestibular incision subperiosteal tunnel access- Randomizes clinical trial
Public title
Root coverage with CAF or VISTA
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Multiple gingival recession in anterior region of mandible
Systemically healthy with no contraindications for periodontal surgery
No need for orthodontic treatment
No caries or restorations on desired teeth
Exclusion criteria:
Systemic conditions or diseases affecting periodontal health, pregnancy or lactation
Substance abuse, smoking
Use of immunosuppressive or anticoagulant drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to one of the study groups with computer generated randomization list.The random allocation sequence will handed to the investigator who performed all of the surgical procedures on the day of surgery.
Blinding (investigator's opinion)
Double blinded
Blinding description
Except the surgeon all of researchers (investigator, outcome assessor, data analyzer) and participants are blind about the procedure
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-09-29, 1398/07/07
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.141
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
Root coverage percentage
Timepoint
Base line, 3 months and 6 months later
Method of measurement
Periodontal probe
2
Description
Complete root coverage
Timepoint
Base line, 3 months and 6 months later
Method of measurement
Periodontal probe
Secondary outcomes
1
Description
Pocket probing depth
Timepoint
Base line, 3 months and 6 months later
Method of measurement
Periodontal probe
2
Description
Clinical attachment level
Timepoint
Base line, 3 months and 6 months later
Method of measurement
Periodontal probe
3
Description
Keratinized tissue width
Timepoint
Base line, 3 months and 6 months later
Method of measurement
Periodontal probe
4
Description
Recession width
Timepoint
Base line, 3 months and 6 months later
Method of measurement
Periodontal probe
5
Description
Recession depth
Timepoint
Base line, 3 months and 6 months later
Method of measurement
Periodontal probe
Intervention groups
1
Description
Intervention group:The VISTA approach begins with a vestibular access incision using 15c scalpel blade. Two vertical incisions will made on both sides of recession area . This is continues at the base of the gingival papillae without affecting their entirety. A microsurgical periosteal elevator (VISTA 1, Dowell Dental Products) will use to create the subperiosteal tunnel with sufficient extension. An elevator with bayonet curves (VISTA 2 and 3, Dowell Dental Products) facilitates access to the gingival sulcus and interproximal areas .The CTG was guided using a horizontal mattress suture within the tunnel by inserting a 3-0 silk suture with a 26-mm 3/8 circle needle. The CTG and mucogingival complex will then advance coronally and stabilize in the new position with a coronally anchore suturing technique using a 6.0 polypropylene suture.
Category
Treatment - Surgery
2
Description
Control group: Two bevelled oblique, slightly divergent, incisions starting at the end of the two horizontal incisions of the distal and mesial teeth and extending to the alveolar mucosa. All of incisions will made with a 15c scalpel blade.The resulting trapezoidal-shaped flap was elevated with in the coronal–apical direction up to exposing 3–4mm of bone apical to the bone dehiscence. The CTG is sutured at the recession area with horizontal double mattress using 6.0 polypropylene suture at the level of buccal CEJ.The gingival margin will advance coronally to the most coronal level of the interproximal papillae.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences, School of Dentistry
Full name of responsible person
Mehrnegar Mahmudzadeh
Street address
Hezarjareeb street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
mehrnegaar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Nakisa Torabinia
Street address
Hezarjareeb street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5512
Email
Torabinia@dnt.mui.ac.ir
Grant name
Grant code / Reference number
398110
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
Zohreh Afshari
Position
post graduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Hezar jareeb street
City
Isfahan
Province
Isfehan
Postal code
8146773461
Phone
+98 31 3792 5570
Email
Z.afshar90@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Jaber Yaghini
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Hezarjareeb street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Email
J_yaghini@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zohreh Afshari
Position
Postgraguat student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Science Hezar jarib St. Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5570
Fax
Email
z.afshar90@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
all data
When the data will become available and for how long
6 month after publication
To whom data/document is available
all people
Under which criteria data/document could be used
systematic review analysis
From where data/document is obtainable
Dr. Mogharehabed
Mogharehabed@dnt.mui.ac.ir
What processes are involved for a request to access data/document