Comparison of Clinical Findings of Two Methods of Using Suture and Tissue Glue
Design
A clinical trial with a control and test group, single blind, unidirectional
Settings and conduct
Patients undergoing surgical procedure for increasing crown length in the maxillary premolar area referred to the periodontology department of the faculty of dentistry of Jondishapur University of Ahvaz have undergone surgery. Then the wound is sutured or closed with tissue glue. During the next sessions, indications for wound healing, presence or non-sensitivity, lower bone matching, postoperative hemorrhage.
Participants/Inclusion and exclusion criteria
Patients undergoing crown lengthening in maxillary premolar teeth with a range of 20-50 years old who are non-smokers with no systemic disease and no history of allergy are selected from patients referring to periodontics department of dental faculty of Ahwaz Jundishapur University.
Intervention groups
Surgical wound closure with tissue glue (Test group) or suture (control group).
Main outcome variables
It is expected that using a tissue adhesive in the amount of pain, wound healing, presence or non-sensitivity, lower bone matching, postoperative hemorrhage compared with sutures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190509043541N1
Registration date:2019-06-22, 1398/04/01
Registration timing:retrospective
Last update:2019-06-22, 1398/04/01
Update count:0
Registration date
2019-06-22, 1398/04/01
Registrant information
Name
Azarnoush Aryankia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 4565
Email address
aryankian-a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two periodontal flap closure methods , suture and tissue adhesive , in crown lengthening surgery .
Public title
Evaluation of different wound closer methode in periodontal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for crown lengthening surgery in maxillary premolars
Exclusion criteria:
Smoker patients
Patient with any past history of systemic disease or sensitivity
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Ethics Committee for Biomedical Research
Street address
Headquarters of the Ministry of Health and Medical Education, Block A, Thirteenth Class, Simay Iran Avenue, Between South Falamak and Zarafshan, Shahrak Ghods
City
Tehran
Province
Tehran
Postal code
5618985991
Approval date
2019-04-28, 1398/02/08
Ethics committee reference number
IR.AJUMS.REC.1398.079
Health conditions studied
1
Description of health condition studied
Crown Lengthening
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postoperative bleeding
Timepoint
3 day after surgery
Method of measurement
On the third day, with the observation and clinical examination of the patient, the rate of postoperative bleeding (divided into: 1 - high bleeding 2 - low and continuous bleeding 3 - low bleeding and accidental bleeding 4 - bleeding 5 - no bleeding) (10) And are recorded on the respective charts.
Secondary outcomes
1
Description
wound healing index
Timepoint
14 days after surgery
Method of measurement
wound healing index by observation and examination Clinical patient (including very weak, weak, satisfactory, good, very good)
2
Description
presence or non-sensitivity
Timepoint
14 days after surgery
Method of measurement
sensitivity to the patient's clinical examination (including sensitization or not)
3
Description
lower bone matching
Timepoint
14 days after surgery
Method of measurement
tissue fitting with the lower bone by observation and clinical examination of the patient (including Adapted and not compliant
4
Description
Pain score
Timepoint
14 days after surgery
Method of measurement
the degree of pain was measured by asking the patient based on the use of VAS (visual scale) scaling from zero to ten (0 = painless to 10 = the worst pain possible)
Intervention groups
1
Description
Control group: suture- in half of the patients silk 0.4 suture is placed and followed for two weeks
Category
Treatment - Devices
2
Description
Intervention group: tissue adhesive- in half of the patients PeriAcryl 90-HV with tissue adhesive. flap tissue is held in place for 2 min until wound is closed.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology, Faculty of Dentistry, Jundishapur University of Ahvaz
Full name of responsible person
Azarnoush Aryankia
Street address
Periodontology Department, Dental College, Jundishapur University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3333 2368
Fax
Email
aryankian_a@agums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badavi
Street address
University of ahvaz, assistant professor of research and technology, university of medical sciences Ahvaz Jundishapur health services- Ground floor
City
ahvaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Azarnoush Aryankia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Academic city, adjacent to Central Office of Jundishapur University of Medical Sciences and Health Services Ahvaz, Deputy Director for Research and Technology Development
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 613332368
Email
aryankiaa@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Azarnoush Aryankia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontology Department, Dental College, Jundishapur University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3333 2368
Email
aryankian-a@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Azarnoush Aryankia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontology Department, Dental College, Jundishapur University of Medical Sciences, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3333 2368
Email
aryankian-a@ajums.ac.ir
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