Evaluation between Periodontal dressing comparison and Cyanoacrylate glue in Minimizing Patient Morbidity in Palatal donor site Following Free Gingival Graft
Evaluation between Periodontal dressing comparison and Cyanoacrylate glue in Minimizing Patient Morbidity in Palatal donor site Following Free Gingival Graft
Design
The donor site was protected by periodontal dressing in the control group and In the test groups, the donor site was protected by Cyanoacrylate glue. single-blind, controlled clinical trial, Two arm parallel group
Settings and conduct
The donor site was protected by periodontal dressing in the control group and In the test groups, the donor site was protected by Cyanoacrylate glue.
Department of Periodontics, University of Qazvin School of Dentistry.
This study is Single-blind.
Participants/Inclusion and exclusion criteria
inclusion criteria: (1) 18 years of age or older; (2) without any reported systemic diseases; (3) having a healthy Periodontium or demonstrating a stable periodontal condition following conventional periodontal therapy; (4) showing full-mouth plaque and bleeding scores< 20%
exclusion criteria : (1) pregnancy; (2) reported use of anticoagulant or anti platelet drugs such as NSAIDs, heparin, Warfarin, etc, or blood-thinning supplements
Intervention groups
The donor site was protected by periodontal dressing in the control group and In the test groups, the donor site was protected by Cyanoacrylate glue
Main outcome variables
Minimizing Patient Morbidity in Palatal donor site
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190520043647N1
Registration date:2019-06-25, 1398/04/04
Registration timing:registered_while_recruiting
Last update:2019-06-25, 1398/04/04
Update count:0
Registration date
2019-06-25, 1398/04/04
Registrant information
Name
Arezoo Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4498 3994
Email address
arezoo.moradi1372@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-15, 1398/01/26
Expected recruitment end date
2019-07-17, 1398/04/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation between Periodontal dressing comparison and Cyanoacrylate glue in Minimizing Patient Morbidity in Palatal donor site Following Free Gingival Graft
Public title
Evaluation of effect of Cyanoacrylate glue in free gingival graft
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
(1) 18 years of age or older
(2) Without any re-ported systemic diseases
(3) Having a healthy periodontium or demonstrating a stable periodontal condition following conventional periodontal therapy
(4) Showing full-mouth plaque and bleeding scores< 20%
Exclusion criteria:
(1) Pregnancy
(2) Use of anticoagulant or anti platelet drugs such as NSAIDs, Heparin, Warfarin, etc, or Blood-thinning supplements
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The Paitients randomized to two groups with simple Randomization with random allocation Software
Blinding (investigator's opinion)
Single blinded
Blinding description
Single-blind, The patient is not aware of the use of Periodontal dressing or Cyanoacrylate tissue adhesive used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofًQazvin University of Medical Sciences
Street address
Shool of Dentistry, Qazvin University of Medical Science, Bahonar Blv, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
1399183639
Approval date
2019-04-13, 1398/01/24
Ethics committee reference number
IR.QUMS.REC.1398.005
Health conditions studied
1
Description of health condition studied
Minimizing Patient Morbidity in Palatal donor siteFollowing free gingival graft
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
In 1 to 14 days after surgery
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Burn feel
Timepoint
In 1 to 14 days after surgery
Method of measurement
Asking from patient, Have or Have not
Intervention groups
1
Description
Intervention group: Cyanoacrylate glue(PeriAcryl 90HV) , In the intervention group, After suturing a few drops of high viscosity Cyanoacrylate apply to the palatal Wound.
Category
Rehabilitation
2
Description
Control group: In the control group, The palatal Wound is covered with Periodontal dressing (Coe-Pak) and inserted into interdental spaces to create mechanical fixation.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Qazvin
Full name of responsible person
Arezoo Moradi
Street address
School of Dentistry, Qazvin University of Medical Science, Bahonar Blv, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
1399183639
Phone
+98 21 4498 3994
Email
Arezoo.moradi1372@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Maryam tofangchiha
Street address
School of Dentistry, Qazvin University of Medical Science, Bahonar Blv, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
1399183639
Phone
+98 21 4498 3994
Email
Arezoo.moradi1372@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Arezoo Moradi
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Qazvin University of Medical Science, Bahonar Blv, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
1399183639
Phone
+98 21 4498 3994
Email
Arezoo.moradi1372@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Arezoo Moradi
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Qazvin University of Medical Science, Bahonar Blv, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
1399183639
Phone
+98 21 4498 3994
Email
Arezoo.moradi1372@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Arezoo Moradi
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Qazvin University of Medical Science, Bahonar Blv, Qazvin, Iran
City
Qazvin
Province
Qazvin
Postal code
1399183639
Phone
+98 21 4498 3994
Email
Arezoo.moradi1372@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