Surgical impacted teeth can be associated with pain and swelling after removal surgery. So analgesia and glucocorticoids for patients undergoing surgery for an impacted tooth are necessary. to reduce discomfort of patients We decided to test new organic drug compounds (Nabid) to its effect on postoperative complications. 30 adult patients, range 17 to 30 years of age, Will be selected. All they need to remove an impacted third molar mandibular surgical procedure to take. teeth lies in radiography, as classified Pell & Gregory in Class 2 and 3 type B and C. local problems like pericoronitis, decay and systemic problems include gastrointestinal disorders, cardiovascular, metabolic and coagulation; use Oral contraceptive drug; pregnancy; use any drugs, antibiotics or painkillers during the 15 days before surgery cause the outflow of patients in the study. All patients have the same surgery. Patients are divided into two groups using random numbers table. Nabid a treatment group and the other group will receive placebo. Nabid Drug Administration (manufactured by Nabid drug) every 4 hours is 15 to 30 drops locally. Dosage placebo is every 4 hours. On the VAS according to the patients they feel pain mark in their 2-6-12-24-48-72 hours. To evaluate edema distances between reference points before surgery and 48 hours after surgery are measure by using an ultrasound device. The trismus analyze by measuring the distance interincisal, 24, 48, 72 hours and 7 days after surgery are measure. On the third day existence of dry socket be checked.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201505293398N3
Registration date:2016-05-17, 1395/02/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-17, 1395/02/28
Registrant information
Name
Alireza Navabazam
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 353624760
Email address
navabazam@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd University of Medical Sciences
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Nabid drug and placebo in controlling some of the complications of impacted mandibular third molars
Public title
Comparison of Nabid drug and placebo in controlling some of the complications of impacted mandibular third molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All they need to remove an impacted third molar mandibular surgical procedure to take; teeth lies in radiography, as classified Pell & Gregory in Class 2 and 3 type B and C
Exclusion criteria: local problems like pericoronitis, decay and systemic problems include gastrointestinal disorders, cardiovascular, metabolic and coagulation; use Oral contraceptive drug; pregnancy; use any drugs, antibiotics or painkillers during the 15 days before surgery
Age
From 17 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoghi University of Medical Sciences
Street address
Shahid Sadoghi University of Medical Sciences, Bahonar Square
City
Yazd
Postal code
8916978477
Approval date
2013-07-24, 1392/05/02
Ethics committee reference number
79791
Health conditions studied
1
Description of health condition studied
mandibular impacted third molar
ICD-10 code
K01.1
ICD-10 code description
An impacted tooth is a tooth that has failed to erupt because of obstruction by another tooth.
Primary outcomes
1
Description
pain
Timepoint
2-6-12-24-48-72 hours after surgery
Method of measurement
by using visual analog scale
Secondary outcomes
1
Description
bleeding
Timepoint
up to 12 hours after surgery
Method of measurement
if exist, record in Questionnaire
2
Description
inflation
Timepoint
1 day before and 48 hours after surgery
Method of measurement
to measure of maseter muscle inflation with ultra sound
3
Description
trismus
Timepoint
24-48-72 hours and 7 days after surgery
Method of measurement
To measure of inter incisal space
4
Description
dry socket
Timepoint
3 days after surgery
Method of measurement
evaluation of creation of dry socket
Intervention groups
1
Description
Nabid drug group patients,should use of nabid drug 15 to 30 drops every 4 hours for 3 days.
Category
Treatment - Drugs
2
Description
use placebo 15-30 drops each 4 hours for 3 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Surgery Department Of Dental School
Full name of responsible person
Mohammad Mahdi Nasiri
Street address
Surgery Department Of Dental School
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research Of Shahid Sadoghi University of Medical Sciences
Full name of responsible person
Dr Amir Hoshang Mehrparvar
Street address
Shahid Sadoghi University Of Medical Sciences, Bahonar Square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research Of Shahid Sadoghi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Surgery Department Of Dental School
Full name of responsible person
Dr Mohammad Mahdi Nasiri
Position
Resident of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Surgery Department Of Dental School
City
Yazd
Postal code
8915813477
Phone
+98 35 3821 0500
Fax
+98 35 3625 0344
Email
mohamadmahdi.nasiri@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University Of Medical Sciences
Full name of responsible person
Dr Alireza Navabazam
Position
Assistant Professor
Other areas of specialty/work
Street address
Surgery Department Of Dental School
City
Yazd
Postal code
8915813477
Phone
+98 35 3623 3261
Fax
+98 35 3625 0344
Email
navabazam@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Surgery Department Of Dental School
Full name of responsible person
Dr Mohammad Mahdi Nasiri
Position
Resident Of Oral and Maxillofacial Surgery
Other areas of specialty/work
Street address
Surgery Department Of Dental School
City
Yazd
Postal code
8915813477
Phone
+98 35 3821 0500
Fax
+98 35 3625 0344
Email
mohamadmahdi.nasiri@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)