evaluation of tissue healing after periodontal surgery using cyanoacrylate adhesive in patients reffering to islamic azad university of tehran in 1397-98
evaluation of tissue helaing after periodontal surgery using cyanoacrylate ahesive and not using it in patients referring to islamic azad university dental branch of tehran in 1397-98
Design
Two arm parallel group randomised trial not blinded postoperative care and outcome assessment
Settings and conduct
this split mouth clinical trial study is performed on the patients referring to the periodontics department of islamic azad university of tehran. all the patients who are indicated for periodontal surgery in 6 sextants or more are evaluating after signing a written and informed agreement. mouth of each patient splits to control and intervention group randomly. to close the wound cyanoacrylate is used in intervention group and 4-0 suture is used in control group. pain is measured by VAS index. tissue healing that is measured bu Landry index and the amount of plaque on the surgery site that is measured by Turesky index is evaluating on the first follow up that is a week after surgery. probing depth of surgery site is measured by a periodontal prob on second follow up that is 6 weeks after surgery.
Participants/Inclusion and exclusion criteria
inclusion criteria: patients who need pocket elimination periodontal surgery in 2 sextants or more
exclusion criteria: patients with systemic diseases that affects tissue healing, using medications that affects the tissue healing, pregnancy, more than 20% of plaque index
Intervention groups
in control group 0000 suture is used after surgery.
in intervention group cyanoacrylate adhesive is used after surgery.
Main outcome variables
pain; plaque index on surgery site; probing depth on surgery site; healing index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120220009088N2
Registration date:2019-10-01, 1398/07/09
Registration timing:registered_while_recruiting
Last update:2019-10-01, 1398/07/09
Update count:0
Registration date
2019-10-01, 1398/07/09
Registrant information
Name
Saeed Sadat Mansouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2291 9455
Email address
s_sadatmansouri@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of tissue healing after periodontal surgery using cyanoacrylate adhesive in patients reffering to islamic azad university of tehran in 1397-98
Public title
evaluation of tissue healing after periodontal surgery using cyanoacrylate adhesive
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients who are indicated for periodontal flap elimination surgery in 2 sextants or more
Exclusion criteria:
patients with systemic diseases that affects tissue healing
using medications that affects tissue healing
pregnancy
more than 20% of plaque index
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
each sextant of each patient is used as a sample
Randomization (investigator's opinion)
Randomized
Randomization description
randomization method: simple randomization
randomization unit: a sextant of patients mouth
randomization instrument: dentists observation
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
Faculty of dentistry, islamic azad university, Tehran.
Street address
no 4, 10th Neyestan, Pasdaran
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2018-12-22, 1397/10/01
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.025
Health conditions studied
1
Description of health condition studied
periodontal surgery for pocket elimination
ICD-10 code
K05
ICD-10 code description
Gingivitis and periodontal diseases
Primary outcomes
1
Description
pain
Timepoint
pain is measured everyday from the day of surgery up to a week.
Method of measurement
Visual Analogue Scale
2
Description
tissue healing index
Timepoint
first follow up that is a week after surgery
Method of measurement
Landry index
3
Description
plaque on surgery site
Timepoint
first follow up that is a week after surgery
Method of measurement
Turesky index
4
Description
probing depth on surgery site
Timepoint
second follow up that is 6 weeks after surgery
Method of measurement
periodontal probe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after surgery on the intended sextant of the patients mouth that is chosen randomly, cyanoacrylate adhesive is used to close the wound. Periacryl90 cyanoacrylate adhesive that is that is a combination of butyl and octyl cyanoacrylate, made in glustitch company in canada, purple colored that is seen when using, in of water and saliva polymerises rapidly. it is used to cover the donor sites of the gum, protecting the sutures and recipient sites,....
Category
Treatment - Other
2
Description
Control group: after surgery on the intended sextant of the patients mouth that is chosen randomly, 4-0 silk suture is used to close the wound. The suture is made in supa company in iran.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic azad university dental branch of tehran
Full name of responsible person
Saeed Sadatmansouri
Street address
No. 9, 9th Neyestan St. , Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2291 9455
Email
s_sadatmansouri@dentaliau.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
No. 9, 9th Neyestan St. , Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2258 0925
Email
drarashazizi@yahoo.com
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
Saeed Sadat Mansouri
Position
Associate professor, Periodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
no 9 , 9th Neyestan , Pasdaran , Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2225 5994
Fax
+98 21 2292 0790
Email
s_sadatmansouri@dentaliau.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saeed Sadat Mansouri
Position
Associate professor, Periodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
no 4 , 10th Neyestan , Pasdaran , Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2225 5994
Fax
+98 21 2292 0790
Email
s_sadatmansouri@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Saeed Sadat Mansouri
Position
Associate professor, Periodontist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
no 9 , 9th Neyestan , Pasdaran , Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2225 5994
Fax
+98 21 2292 0790
Email
s_sadatmansouri@dentaliau.ac.ir
Web page address
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