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Evaluation of wound healing quality and patient comfort by tissue cyanomethacrylate adhesive in comparison with classical suture in the area of free gingival transplantation

Protocol summary

Study aim
Evaluation of wound healing quality and patient comfort by tissue cyano methacrylate adhesive in comparison with classical suture in the area of free gingival transplantation
Design
This study will be a randomized, parallel, single-blind, phase 3 clinical trial. The sample size will be considered 64 people and will be divided into 4 groups using the block randomization method. Stata software and ralloc package will be used to assign participants to study groups.
Settings and conduct
This study will be done on patients referred to a private practice in Ilam city. data analyzer will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 25 to 50 years; Acceptable oral hygiene before surgical treatment; Patients with gingivitis who have a probe depth of 5 mm in three consecutive teeth in at least two quadrants. Exclusion criteria: Patients with known systemic diseases; Drug allergy; Obsessive and mental disorders; smoking; chewing tobacco; Pregnant women
Intervention groups
For the first group, the open wound which created in the palatal, will be sutured with 0-3 silk thread from Supa classic brand and the wound will be closed. For the second group, the open wound which created in the palatal, will be covered by cyanomethacrylate oral adhesive. For this purpose, after the wound, the powder which prepared by GS company will be mixed with the accompanying liquid, and then an oral adhesive will be created and the wound will be covered with this oral adhesive. For the third group, the open wound which created in the palatal, half of it will be sutured with 0-3 silk thread from Supa Classic brand, and the other half will be covered with cyanomethacrylate oral adhesive. For the fourth group, which is the control group, no Intervention will be taken for the open wound.
Main outcome variables
Bleeding index; Pain index; Recovery index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220904055872N1
Registration date: 2022-09-24, 1401/07/02
Registration timing: prospective

Last update: 2022-09-24, 1401/07/02
Update count: 0
Registration date
2022-09-24, 1401/07/02
Registrant information
Name
Zeynab Abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3223 5024
Email address
avin.abs676@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-07, 1401/07/15
Expected recruitment end date
2022-12-06, 1401/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of wound healing quality and patient comfort by tissue cyanomethacrylate adhesive in comparison with classical suture in the area of free gingival transplantation
Public title
Comparison of cyano methacrylate glue and suture in palatal wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 25 to 50 years Acceptable oral hygiene before surgical treatment Patients with gingivitis who have a probe depth of 5 mm in three consecutive teeth in at least two quadrants
Exclusion criteria:
Patients with known systemic diseases or drug therapy that may interfere with wound healing Drug allergy Obsessive and mental disorders smoking chewing tobacco Pregnant women or mother has given birth
Age
From 25 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 64
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the randomization unit is the individual. In order to allocation of people into 4 study groups, the block randomization method will be used. In this way, by considering 8 permutations (2 repetitions for each group in each permutation), the sequence of blocks will be determined. A number will be assigned to each block and then a number will be selected using the random number table and according to the number on the right side of the selected random number, the block should be used, will be determined. Stata software and ralloc package will be used to create the sequences. Since the permutations will be labeled with the random code that assigned by the software, allocation concealment will be applied.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since the wound healing chart will be completed by the periodontist, there will be no possibility of blinding. But considering that the collected information will be coded, single-blinding will be implemented for the Data analyzer.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ilam University of Medical Sciences
Street address
Ilam town beheshti blvd payam ave tarnian allay
City
Ilam
Province
Ilam
Postal code
6931313119
Approval date
2022-09-03, 1401/06/12
Ethics committee reference number
IR.MEDILAM.REC.1401.087

Health conditions studied

1

Description of health condition studied
palatal wound
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
wound healing index
Timepoint
5 and 7 days after surgery
Method of measurement
examination by periodontist

2

Description
bleeding inndex
Timepoint
5 and 7 days after surgery
Method of measurement
examination by periodontist

3

Description
pain index
Timepoint
5 and 7 days after surgery
Method of measurement
examination by periodontist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the first group, the open wound created in the palate will be sutured with 0-3 silk thread from supa classic suture and the wound will be closed.
Category
Treatment - Other

2

Description
Intervention group: For the second group, the open wound which created in the palate is covered by cyanomethacrylate oral adhesive. For this purpose, after the wound, the powder prepared by GS company will be mixed with the accompanying liquid, and then an adhesive oral adhesive will be created and the wound will be covered with this mater.
Category
Treatment - Other

3

Description
Intervention group: For the third group, the open wound which created in the palate, half of it will be sutured with 0-3 silk thread from supa classic suture, and the other half will be covered with cyanomethacrylate oral adhesive.
Category
Treatment - Other

4

Description
Control group: For the fourth group, which is the control group, no action will be taken for the open wound in the palate.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Abdi's personal office
Full name of responsible person
Zynab Abdi
Street address
Ilam town beheshti blvd payam Ave tarnian allay
City
Ilam
Province
Ilam
Postal code
6931313119
Phone
+98 84 3223 5024
Email
Avin.abs676@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Abbas Maleki
Street address
Ilam University of Medical Sciences campus, Banganjab, Research Blvd
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
abbasmaleki_ilam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Fatemeh abbasi
Position
General dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ilam town beheshti blvd payam ave tarnian allay
City
Ilam
Province
Ilam
Postal code
6931313119
Phone
+98 84 3223 5024
Email
Avin.abs676@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Zeynab Abdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Azadi blvd azadi 9 ave sepanta apartment
City
Ilam
Province
Ilam
Postal code
6931433373
Phone
+98 84 3223 5024
Email
zeynab_dent@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Reza pakzad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Beheshti blvd payam ave tarnian allay
City
Ilam
Province
Ilam
Postal code
6931313119
Phone
+98 84 3223 5024
Email
rezapakzad2010@yahoo.com

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
datas that there is no problem to publish them will be published
When the data will become available and for how long
Six months after the results are published
To whom data/document is available
Researchers and students
Under which criteria data/document could be used
Doing research work
From where data/document is obtainable
Fatemeh abbasi Avin.abs676@gmail.com
What processes are involved for a request to access data/document
It will be sent to the person's email address for a maximum of one month
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