Comparison of the effect of suture with and without cyanoacrylate glue on restoration and patients' satisfaction undergoing oral mucosal surgery: a randomized clinical trial
To compare the effect of suture with and without cyanoacrylate glue on restoration and patients' satisfaction undergoing oral mucosal surgery
Design
This is a randomized clinical trial, phase II, in which 20 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients who are candidate for undergoing oral mucosal surgery and will refer to Dental Clinic of Islamic Azad University in Tehran City during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
Patients who are the candidate for undergoing oral mucosal surgery (implant placement or alveoplasty)
Exclusion criteria:
Pregnancy or breastfeeding
Using alcohol;
Using opium;
Sensitivity to cyanoacrylate glue
Intervention groups
Intervention group:
Oral mucosal surgery and then suturing with cyanoacrylate glue
Control group:
Oral mucosal surgery and then suturing without cyanoacrylate glue
Main outcome variables
Primary outcome:
Restoration of the location of surgery
Patients' satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N261
Registration date:2019-02-11, 1397/11/22
Registration timing:retrospective
Last update:2019-02-11, 1397/11/22
Update count:0
Registration date
2019-02-11, 1397/11/22
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-21, 1396/08/30
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of suture with and without cyanoacrylate glue on restoration and patients' satisfaction undergoing oral mucosal surgery: a randomized clinical trial
Public title
Comparison of the effect of suture with and without cyanoacrylate glue on restoration and patients' satisfaction undergoing oral mucosal surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years
Patients who are candidate for undergoing oral mucosal surgery (implant placement or alveoplasty)
Exclusion criteria:
Pregnancy or breastfeeding
Using alcohol
Using opium
Sensitivity to cyanoacrylate glue
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring to each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
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
Ethics Committee of Islamic Azad University, Tehran Dental Branch
Street address
Tehran Dental Branch, Islamic Azad University, Ninth Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2017-11-12, 1396/08/21
Ethics committee reference number
IR.IAU.DENTAL.REC.1396.30
Health conditions studied
1
Description of health condition studied
Dental implant
ICD-10 code
M27.6
ICD-10 code description
Endosseous dental implant failure
Primary outcomes
1
Description
Restoration of the location of surgery
Timepoint
On the seventh day after surgery
Method of measurement
Through physical examination
2
Description
Patients' satisfaction
Timepoint
On the seventh day after surgery
Method of measurement
By taking history
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Oral mucosal surgery and then suturing with cyanoacrylate glue
Category
Treatment - Surgery
2
Description
Control group: Oral mucosal surgery and then suturing without cyanoacrylate glue
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Islamic Azad University
Full name of responsible person
Seyyedeh Negar NedaDahandeh
Street address
Tehran Dental Branch, Islamic Azad University, Ninth Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 8145 5618
Email
Nedadahandeh81@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Arash Azizi
Street address
Vice-chancellor for Research and Technology, Tehran Dental Branch, Islamic Azad University, Ninth Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 8145 5618
Email
ethics@hbi.ir
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
Seyyedeh Negar NedaDahandeh
Position
Dental Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tehran Dental Branch, Islamic Azad University, Ninth Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 8145 5618
Email
Nedadahandeh81@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyyedeh Negar NedaDahandeh
Position
Dental Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tehran Dental Branch, Islamic Azad University, Ninth Neyestan, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 8145 5618
Email
Nedadahandeh81@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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