The goal of this study is to evaluate the effects of using ice pack on postoperative complications (trismus, edema, pain) of impacted molar surgery.We perform this study on 30 Patients aged 17 to 30 years old with bilateral impacted mandibular third molars. All patients who participate in this study should be healthy without any significant medical problem. The impacted mandibular teeth on both sides should be in nearly the same angulation and position and should have same degree of surgical difficulty on panoramic radiographs. Exclusion criteria include presence of any systemic disease, drug consumption, and pathologic lesion in the third molar area. In each patient, the impacted tooth on one side (study side) is removed with instruction to use ice pack intermittently for 6 hours after surgery. The tooth on the other side (control side) will be removed with no use of postoperative ice pack. The study and control sides and their priority for surgery are randomly selected.The time interval between surgical removal study and control sides should be at least one month.
The severity of pain and the degree of edema and trismus were recorded on the second and seventh postoperative days and compared with the baseline preoperative
measurements. The examiner who measures the variables is blind to the design and purpose of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410214303N3
Registration date:2014-10-23, 1393/08/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-23, 1393/08/01
Registrant information
Name
Mohammad Zandi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1823 4047
Email address
zandi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of ice pack therapy on reduction of sequelae after mandibular third molar surgery
Public title
Evaluation of the effect of ice pack therapy on reduction of sequelae after surgery of wisdom tooth in the lower jaw
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Healthy patients with bilateral impacted mandibular third molars. The
impacted teeth on both sides should be in nearly same angulation and position and should have same degree of surgical difficulty on panoramic radiographs.
Exclusion criteria: Presence of any systemic disease, drug consumption, and pathologic lesion in the third molar area.
Age
From 17 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committeeو Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Postal code
65178
Approval date
2014-10-15, 1393/07/23
Ethics committee reference number
3461/9/35/16/پ
Health conditions studied
1
Description of health condition studied
Postoperative complications
ICD-10 code
K01.1
ICD-10 code description
Embedded teeth
Primary outcomes
1
Description
Trismus
Timepoint
Before surgery, 2 and 7 days after surgery
Method of measurement
Distance between upper and lower central incisal edge
2
Description
Edema
Timepoint
Before surgery, 2 and 7 days after surgery
Method of measurement
Sum of distances from the corner of the mouth to the tragus and from the lateral canthus of the eye to the angle of the mandible
3
Description
Pain
Timepoint
Before surgery, 2 and 7 days after surgery
Method of measurement
Four-point scale (0, no pain; 1, mild pain; 2, moderate pain; 3, severe pain)
Secondary outcomes
empty
Intervention groups
1
Description
Ice pack therapy
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zandi
Street address
Department of oral and maxillofacial surgery, Faculty of Dentistry, Shahid Fahmideh street
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Bashirian, Vice- Chancellor of university in research affairs
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Faculty of Dentistry, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zandi
Position
Associate Professor of Oral and Maxillofacial surgery
Other areas of specialty/work
Street address
Faculty of Dentistry, Shahid Fahmideh street
City
Hamadan
Postal code
65178-38677
Phone
+98 81 3838 0717
Fax
+98 81 3823 4014
Email
zandi88m@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zandi
Position
Associate Professor of Oral and Maxillofacial surgery
Other areas of specialty/work
Street address
Faculty of Dentistry, Shahid Fahmideh street
City
Hamadan
Postal code
65178-38677
Phone
+98 81 3838 0717
Fax
+98 81 3823 4014
Email
zandi88m@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Dentistry, Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Zandi
Position
Associate Professor
Other areas of specialty/work
Street address
Faculty of Dentistry, Shahid Fahmideh street
City
Hamadan
Postal code
65178-38677
Phone
+98 81 3838 0717
Fax
+98 65 1783 8677
Email
zandi88m@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)