Compare analgesic effect of Gelofen and Naproxen in lower third molar surgery
Design
Block randomization, randomized patients into four groups (n=20); Pre-Gelofen group: Patients received 400 mg Gelofen 30 minute before surgery and continued taking it every 6 hours postoperatively, Gelofen group: patients received 400 mg Gelofen immediately after the operation and continued taking it every 6 hours postoperatively. In Pre-Naproxen group: patients received 500 mg Naproxen 30 minute before surgery and continued taking it every 8 hours postoperatively. In Naproxen group: patients received 500 mg Naproxen immediately after the operation and continued it every 8 hours postoperatively. An experienced surgeon operated for all of the patients.
Settings and conduct
The study was related to third molar teeth surgery which was conducted in Shiraz School of Dentistry. Patients who attended this center for third molar surgery were asked to voluntarily participate in the study. The patient was blind by covering the capsules
Participants/Inclusion and exclusion criteria
all of the patients signed an informed consent before their participation in the study. All of the patients had an impact mandibular third molar and were in ASA 1 category. All impact teeth were in level A and class 1 according to Pell and Gregory classification. None of the patients received analgesic medication at least 12 hours before the surgery. Exclusion criteria were any condition which contraindicated the use of NSAIDs, such as pregnancy, known allergy to NSAIDs, any drugs interaction, active ulceration or gastrointestinal bleeding, liver dysfunction, inflammatory intestinal disease, kidney dysfunction, or any psychological disorders.
Intervention groups
Pain intensity after lower third molar surgery between those who have received Gelofen compared to those received Naproxen
Main outcome variables
Pain intensity after the surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180330039161N1
Registration date:2018-09-10, 1397/06/19
Registration timing:retrospective
Last update:2018-09-10, 1397/06/19
Update count:0
Registration date
2018-09-10, 1397/06/19
Registrant information
Name
Saeid Tavanafar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 6655
Email address
Tavanafar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-16, 1396/09/25
Actual recruitment start date
2017-07-05, 1396/04/14
Actual recruitment end date
2017-09-21, 1396/06/30
Trial completion date
empty
Scientific title
Comparison of Naproxen and Gelofen for Pain Relief in the Third Molar Surgery:A single-blind randomized clinical trial study
Public title
Different pain killer for third molar surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
an impact mandibular third molar
ASA 1 category
level A and class 1 according to Pell and Gregory classification
No analgesic medication at least 12 hours before the surgery
Exclusion criteria:
pregnancy
known allergy to NSAIDs
drugs interaction
active ulceration or gastrointestinal bleeding
liver dysfunction
inflammatory intestinal disease
kidney dysfunction
psychological disorders
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
block individual table randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Both medication had similar capsules
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
none
Secondary trial Id
none
Registration date
2017-12-11, 1396/09/20
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Qom Abad, Ghasrodasht Street
City
Shiraz
Province
Fars
Postal code
7134647379
Approval date
2017-04-09, 1396/01/20
Ethics committee reference number
IR.SUMS.REC.1396.122
Health conditions studied
1
Description of health condition studied
Pain after lower third molar surgery
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
Pain intensity after third molar surgery
Timepoint
pain intensity at 2, 6, 12 and 24 hours after intervention
Method of measurement
visual analogue scale to measure pain
Secondary outcomes
1
Description
none
Timepoint
none
Method of measurement
none
Intervention groups
1
Description
Control group: 400 mg Gelofen immediately after third molar surgery and continuing every 6 hours
Category
Treatment - Drugs
2
Description
Intervention group 1: 400 mg Gelofen 30 minute pre-operative and continuing every 6 hours,
Category
Treatment - Drugs
3
Description
Intervention group 2: 500 mgNaproxen 30 minute pre-operative and every 8 hours
Category
Treatment - Drugs
4
Description
Intervention group 3: 500mg Naproxen immediately postoperative and every 8 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Hayati
Street address
Ghasrodasht street, Gomabad District
City
Shiraz
Province
Fars
Postal code
7134647379
Phone
+98 17 3230 6655
Email
tavanafar@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehdi Hayati
Street address
Ghasro ِDasht Street, Gom Abad District
City
Shiraz
Province
Fars
Postal code
7134647379
Phone
+98 71 3230 6655
Email
tavanafar@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
10
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
Shiraz University of Medical Sciences
Full name of responsible person
Saeid Tavanafar
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Gomabad District, Ghasrodasht Street
City
Shiraz
Province
Fars
Postal code
7134647379
Phone
+98 71 3230 6655
Email
tavanafar@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Saeid Tavanafar
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Gomabad District, Dasrodasht street
City
Shiraz
Province
Fars
Postal code
7134647397
Phone
+98 71 3230 6655
Email
tavanafar@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Saeid Tavanafar
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Gomabad District, Ghasrodasht street
City
Shiraz
Province
Fars
Postal code
7134647397
Phone
+7 132306655
Email
tavanafar@sums.ac.ir
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
IPD collected for the primary outcome measure only
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
only available for people working in academic institutions
Under which criteria data/document could be used
For scientific researches and only for academic staff
From where data/document is obtainable
by Email to : "s.tavanafar@gmail.com" or "tavanafar@sums.ac.ir"
What processes are involved for a request to access data/document