Comparison of effectiveness of the two methods of Coronally advanced flap with connective tissue graft and Vestibular incision subperiosteal tunnel acces with connective tissue graft in treatment of gingival recession in patients with gingival recession type I, III Miller
clinical evaluation of two different methods of gingival recession treatment
Design
Clinical Trial, include two groups: one as control group and another as intervention group, with unilaterally blindness of patients.
With available sampling 5 patients are selected, that each one has three pairs of teeth with gingival recession.
Due to no medications, the clinical trial phase is not applicable.
Settings and conduct
For each patient based on Simple randomization, left teeth determine as intervention group and right ones as controlled group. Treatment for intervention group is done by VISTA technique, and for controlled group by CAF technique in Dental Clinic, Faculty of Dentistry, Bushehr University of Medical Sciences. For both groups the connective tissue graft takes from palatal de_epithelialization connective tissue in region of the premolar_first molar.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) People aged over 18 years old
2) Gingival recession type I, III Miller
3) Absence of uncontrolled systemic disease
4) No smoking
5)َ Absence of active periodontal disease symptoms
6) Probing depth less than 3 mm
7) Bleeding index and plaque less than 20%
Exclusion criteria:
1) People who are in periodontal surgery phases
2) Those who take medications that affect gum and wound healing
3) Pregnant women
4) Those undergoing orthodontic treatment
5) Abrasion or filling in the area of cementoenamel junction
6) Malposed teeth
7) Teeth with surgical history in recession area
Intervention groups
Intervention group: treatment of gingival recession type I, III Miller by method of Vestibular Incision Subperiosteal Tunnel Acces (VISTA) with connective tissue graft
Control group: treatment of gingival recession type I, III Miller by method of Coronally Advanced Flap (CAF) with connective tissue graft
Main outcome variables
depth of gingival recession
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190803044416N1
Registration date:2019-09-08, 1398/06/17
Registration timing:retrospective
Last update:2019-09-08, 1398/06/17
Update count:0
Registration date
2019-09-08, 1398/06/17
Registrant information
Name
Yasaman Mojarrad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3422 9421
Email address
y.mojarrad@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-06, 1397/11/17
Expected recruitment end date
2019-02-14, 1397/11/25
Actual recruitment start date
2019-02-06, 1397/11/17
Actual recruitment end date
2019-02-14, 1397/11/25
Trial completion date
2019-08-16, 1398/05/25
Scientific title
Comparison of effectiveness of the two methods of Coronally advanced flap with connective tissue graft and Vestibular incision subperiosteal tunnel acces with connective tissue graft in treatment of gingival recession in patients with gingival recession type I, III Miller
Public title
Comparison of two the methods of Coronally advanced flap with connective tissue graft and Vestibular incision subperiosteal tunnel acces with connective tissue graft in treatment of gingival recession type I, III Miller
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
people aged over 18 years old
gingival recession type I, III Miller
absence of uncontrolled systemic disease
no smoking
absence of active periodontal disease symptoms
probing depth less than 3 mm
bleeding index and plaque less than 20%
Exclusion criteria:
people who are in periodontal surgery phases
those who take medications that affect gum and wound healing
pregnant women
those undergoing orthodontic treatment
abrasion or filling in the area of CEJ (cementoenamel junction)
malposed teeth (teeth which not placed in their right position)
teeth with surgical history in recession area
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
5
More than 1 sample in each individual
Number of samples in each individual:
6
Symmetrical teeth in right and left side of maxilla which have gingival recession type I, II Miller
Actual sample size reached:
5
More than 1 sample in each individual
Actual sample size in each individual:
6
Symmetrical teeth in right and left side of maxilla which have gingival recession type I, II Miller
Randomization (investigator's opinion)
Randomized
Randomization description
At the beginning of research, by use of simple randomization (flipping a coin), the right teeth was assigned to the control group and the left ones to the intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding was performed unilaterally so that patients were unaware of the assignment of the left and right teeth to the control or intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of bushehr University of Medical Sciences
Street address
Moallem St, Kuy-e-Bandar,Bandar Bushehr,Bushehr Province
City
busher
Province
Boushehr
Postal code
7514633196
Approval date
2019-02-05, 1397/11/16
Ethics committee reference number
IR.BPUMS.REC.1397.104
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
Depth of gingival recession
Timepoint
Baseline, 3 and 6 months postoperatively
Method of measurement
by Michigan periodontal probing instrument
Secondary outcomes
1
Description
Width of keratinized gingiva
Timepoint
Baseline, 3 and 6 month postoperatively
Method of measurement
By Michigan periodontal probing instrument
Intervention groups
1
Description
Control group: treatment of gingival recession type I, III Miller by method of Coronally advanced flap with connective tissue graft which is taken from palatal de_epithelialized connective tissue in region of the premolar_first molar.
Category
Treatment - Surgery
2
Description
Intervention group: treatment of gingival recession type I, III Miller by method of Vestibular Incision Subperiosteal Tunnel Acces (VISTA) with connective tissue graft which is taken from palatal de_epithelialized connective tissue in region of the premolar_first molar.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental clinic of Bushehr University of Medical Sciences
Full name of responsible person
Seyed Ammar Basri
Street address
Moallem St, Kuy-e-Bandar,Bandar Bushehr,Bushehr Province
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3422 9421
Email
basriab63@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholam Reza Khamisipour
Street address
Moalem st.
City
Bushehr
Province
Boushehr
Postal code
7514633196
Phone
+98 77 3345 0178
Email
basriab63@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Seyed Ammar Basri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Moalem st.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
basriab63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Seyed Ammar Basri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Moalem st.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3422 9421
Email
basriab63@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Seyed Ammar Basri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Moalem st.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3422 9421
Email
basriab63@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