The aim of this study was to determine the effect of cyanocrylate adhesive on the clinical parameters of Postoperative wound healing following free gingival graft
Design
Two arm parallel group, randomized controlled trial with blinding
Settings and conduct
This double blind Randomized control clinical trial was conducted on 15 patients requiring free gingival graft in two quadrants . Each patient's mouth was randomly divided into case and control groups, and in the case group, cyanoacrylate adhesive was applied to the Palate Donor site . In the control group, the donor site was sutured , and the periodontal pack ( Coepack ) was placed on it.The thickness of the graft must be between 1-1.5 mm and the both sides graft length be the same.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients requiring Free Gingival Graft in two quadrants.
Exclusion Criteria: 1) systemic disease
2)Pregnancy
3)The Presence of Painful Conditions in oral cavity such as teeth requiring root canal therapy.
4)smoking , alcohol or drug abuse
5)Surgical History in the last 6 months
6)Trauma
Intervention groups
Each patient's mouth was randomly divided into case and control groups, and in the case group, cyanoacrylate adhesive was applied to the Palate Donor site . In the control group, the donor site was sutured according to the usual method, and the periodontal pack ( Coepack )was placed on it.
Main outcome variables
1) pain by VAS scale
2) Healing Scale
3) Measuring the dimensions of wound by photography
4) Epithelialization by H2O2 Application 3%
5) Discomfort scale
6) The presence or absence of delayed and Immediate bleeding
7) The sensitivity disorder
8) Normal feeding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120311009260N3
Registration date:2019-03-17, 1397/12/26
Registration timing:retrospective
Last update:2019-03-17, 1397/12/26
Update count:0
Registration date
2019-03-17, 1397/12/26
Registrant information
Name
Mohammad Reza Karimii
Name of organization / entity
Islamic Azad university Dental Branch
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 4746
Email address
m_karimi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-24, 1397/09/03
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Cyanoacrylate adhesive on clinical parameters of postoperative wound healing following free gingival graft
Public title
Effect of Cyanoacrylate adhesive on wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who require free gingival graft in two quadrants
Exclusion criteria:
systemic disease
Pregnancy
The presence of painful conditions in oral cavity such as teeth requiring root canal therapy
smoking , alcohol or drug abuse
Surgical history in the last 6 months
Trauma
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
َAll the Patients requiring free gingival graft , the mouth of each patient is randomly divided into case and control group .
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling.
Randomization with Computer generated randomization list ( Microsoft Excel 2016 )
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single blind , and the patient is blind to the donor site treatment .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad university tehran Dental Branch
Street address
no 4,9th Neyestan .Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2018-04-22, 1397/02/02
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.037
Health conditions studied
1
Description of health condition studied
The wound healing following free gingival graft
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
After A week , a month and 3 months.
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Epithelialization
Timepoint
After a week , a month and 3 months
Method of measurement
The amount of epithelization is evaluated by the use of H2O2% 3 in the area and the presence or absence of bubbles. If the intact epithelium membrane is formed, H2O2 will not penetrate the area and no bubble will be produced. Therefore, not seeing the bubble after application of H2O2% 3 is a sign of Complete Epithelialization, and if the bubble is seen in more than 2/3 of the area, Mild and Between 1/3 to 2/3 Moderate and less than 1/3 Complete Epithelialization has occuerd .
Intervention groups
1
Description
Intervention group: In the case group after the graft harvetsing , the cyanoacrylate adhesive applied to the donor site .
Category
Treatment - Drugs
2
Description
In the control group after the graft harvetsing , the donor site was sutured and the periodontal pack applied .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University Tehran dental branch
Full name of responsible person
Dr mohammadreza karimi
Street address
No 4, 9th. Neyestan, Pasdaran St.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4570
Fax
+98 21 2256 4571
Email
m_karimi@dentaliau.ac.ir
Web page address
http://dentaliau.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No 4, 9th Neyestan, Pasdaran Street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Fax
+98 21 2256 4570
Email
a_azizi@dentaliau.ac.ir
Web page address
http://dentaliau.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Dr. Mohammadreza Karimi
Position
Assistant professor, department of periodontology of islamic azad university
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 4, 9th neyestan, pasdaran street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2276 3449
Fax
Email
m_karimi@dentaliau.ac.ir
Web page address
http://dentaliau.ac.ir/fa
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mohammadreza Karimi
Position
Assistant professor of department of periodontology, islamic azad university
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of periodontology, no 4, 9th neyestan, pasdaran street
City
tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2276 3449
Fax
Email
m_karimi@dentaliau.ac.ir
Web page address
http://dentaliau.ac.ir/fa
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ghazal Anoosh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Department of periodontology, no 4, 9th Neyestan, Pasdaran street
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2276 3449
Fax
Email
ghazal_anoush@yahoo.com
Web page address
http://dentaliau.ac.ir/fa
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data including post operation pain , wound healing m epithelialization and other clinical parameters will be shared .
When the data will become available and for how long
6 months after publition
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Dental academic groups would be able receive the data by contacting the research authorities.
From where data/document is obtainable
Dr mohammadreza karimi , m_karimi@dentaliau.ac.ir
What processes are involved for a request to access data/document
Authorized letter from scientific organization should be sent to Tehran dental branch , Islamic Azad University. Following the approval by authorities , the data will be released during a period of 6 month.