The effect of locally applied gelofen in postoperative complication after wisdom surgery
Design
Clinical trial with control group, double-blind,randomized
Settings and conduct
The study will be carried out at the Ardebil Dental School. This double-blind study is a simple randomized controlled trial in which the evaluator and participants are blinded. The intervention group are treated with gelofen-containing gelfoam placed in empty caries of wisdom teeth, and the control group will receive a treatment with gelofen-free gelfoam. Post-operative complications such as pain, bleeding, dry cavity, and swelling will be examined by a questionnaire and through patient examination on days after the surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria were the age of 14-65 years, having mandibular impacted wisdom teeth،signature of consent
Exclusion criteria included pregnancy, painkiller use, and drug abuse, systemic disease
Intervention groups
The intervention group is treated with gelofen-containing gelfoam(Apadana tak Co.,Iran) in the socket of wisdom teeth. The contents of a 400 mg gelofen tablet (Jaber-ibne Hayan Co., Iran) is discharged by a syringe containing 1 cc of gelofen, then transferred to the gelfoam, and inserted into dental socket. The control group will be treated with gelofen-free gelfoam.
Main outcome variables
Pain, bleeding,trismus,Swelling،dry socket
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181215041988N1
Registration date:2019-07-11, 1398/04/20
Registration timing:retrospective
Last update:2019-07-11, 1398/04/20
Update count:0
Registration date
2019-07-11, 1398/04/20
Registrant information
Name
Pouyan Sigari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4454 1504
Email address
p.sigari@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-08, 1398/03/18
Expected recruitment end date
2019-07-09, 1398/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of locally applied gelofen in postoperative complication after wisdom tooth surgery
Public title
Gelofen in wisdom tooth surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having an impacted mandibular wisdom tooth
Age between 14 and 65 years
Signature of consent
Exclusion criteria:
Systemic disease
Pregnancy
Drug abuse
Using anti_ analgesic grug
Age
From 14 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
This study will be performed as a randomized double-blind trial in which the patient and the examiner will be absolutely unaware of the contents of the envelope provided to the surgeon. To this end, a total of 34 apparently similar envelopes will be selected and placed in a 17 surgical card packs together with gelofen, and the other 17 surgical envelopes contain no gelofen. The surgeon chooses randomly one of the envelopes before surgery, and will perform the operation according to the envelope type.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, only the researcher( surgeon) will be informed of the main drug or placebo assigned to each patient. The participants will not be informed of the sucket contents of the surgery .The patient does not see a dental sucket during surgery and the evaluator is also absent during surgery.Neither the participant nor evaluator not know who is in which group .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Ardabil University of Medical Sciences
Street address
Vice President of Research،northern side of Ardabil University of Medical Sciences،University Square،University Street
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2019-05-25, 1398/03/04
Ethics committee reference number
IR.ARUMS.REC.1398.085
Health conditions studied
1
Description of health condition studied
Wisdom surgery
ICD-10 code
Y56.7
ICD-10 code description
Dental drugs, topically applied
Primary outcomes
1
Description
Pain
Timepoint
2,4,6,12,24,48 hours after surgery
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
Bleeding
Timepoint
2 days after surgery
Method of measurement
questionnaire
2
Description
Swelling
Timepoint
2 days after surgery
Method of measurement
Measured by ruler from comissure of lip_ lop of ear and countus of eye _ Angle of mandible
3
Description
Trismus
Timepoint
2 days after surgery
Method of measurement
distance between the upper and lower incisal edges in millimeters.
4
Description
Dry sucket
Timepoint
2 days after surgery
Method of measurement
Examination
Intervention groups
1
Description
The intervention group is treated with gelofen-containing gelfoam in the socket of wisdom teeth. The contents of a 400 mg gelofen tablet (Jaber-ibne Hayan Co., Iran) is discharged by a syringe containing 1 cc of gelofen, then transferred to the gelfoam(Apadanatac Co.,Iran).
Category
Treatment - Drugs
2
Description
Control group: The control group is treated with gelofen-free gelfoam (Apadanatak Co.، Iran. placebo)in the socket of wisdom teeth.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Ardabil School of Dentistry
Full name of responsible person
Pouyan Sigari
Street address
Clinic of ardabil school dentistry, Daneshgah Blv, Janbazan Square
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 45 3352 3890
Fax
+98 45 3351 0054
Email
dentistry@arums.ac.ir
Web page address
http://www.arums.ac.ir/dentistry/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahab bohluli
Street address
Vice President of Research،northern side of Ardabil University of Medical Sciences،University Square،University Street
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4776
Fax
+98 45 3353 4757
Email
research@arums.ac.ir
Web page address
http://www.arums.ac.ir/vcresearch/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Pouyan Sigari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ardabil university of medical sciences,Daneshgah Ave,Janbazan square,Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 21 4454 1504
Fax
Email
P.Sigari@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Pouyan Sigari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ardabil university of medical sciences,Daneshgah Ave,Janbazan square,Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
5618953141
Phone
+98 21 4454 1504
Fax
+98 45 3351 0054
Email
P.Sigari@arums.ac.ir
Web page address
http://www.arums.ac.ir/dentistry/fa
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Fahimeh Mirakhorloo
Position
دانشجو
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 3، No. 123، Farhangian Town, West of Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۹۷۸۶۴۶۶۴
Phone
+98 21 4454 1504
Email
Fahimeh.mirakhorloo_22@yahoo.con
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