Orthodontic movement associated pain is one of the problems in the early days after the force application. Laser irradiation is one of the latest topical techniques and effective on pain relief. The aim of this study is comparison of low level laser effect with acetaminophen on pain relief after separator placement of orthodontic treatment.
This randomized, double-blind clinical trial will be done in 1392. For 66 samples (33 men and 33 women) aged 18 to 30 years of orthodontic patients or volunteer students, eight separators will be placed in the mesial and distal of the first molars teeth. Participants will be randomly matched with one of the three groups, sex matching also will be made: the laser group (laser radiation – drug placebo), acetaminophen group (laser off - drug) and laser-acetaminophen group (laser radiation - drug). The participants will receive 9 tablets (acetaminophen 500 mg Jalinous Company or similar placebo) that will take an hour before separator placement and will continue every 6 hours. Laser will radiate immediately and 24 hours after separator placement to eight points per quadrant for 4 seconds that will be low level laser or off with the same sound. Participants will be specified the pain that they feel at 0, 1, 6, 12, 24, 48 hours after separator placement by numerical scale of zero (no pain) to 10 (worst pain) in the questionnaire. Separators will be removed 48 hours after placement.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022312568N1
Registration date:2013-03-27, 1392/01/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-03-27, 1392/01/07
Registrant information
Name
Fariba Shahri
Name of organization / entity
Zahedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 54 1242 0940
Email address
shahri@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology Assistance of Zahedan University of Medical Science
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-06-05, 1392/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of low-level laser therapy and acetaminophen on pain after the separator placement in orthodontic treatment
Public title
Laser effects on pain after separator placement in orthodontic treatment.
Purpose
Supportive
Inclusion/Exclusion criteria
Intrusion criteria:
Age 18 to 30 years; All teeth in two jaws till second molar before treatment, are fully grown and second premolars, first and second molars are in contact; So let's put the two separator at the mesial and distal to the four first molars.
Exclusion criteria:
Dependence on psychoactive drugs; History of taking anti epileptic and antidepressant drugs; A history of chronic systemic diseases such as liver disease, lung, kidney and heart disease and so on; History of neuropathic disorders (diabetic neuropathy, trigeminal neuralgia (trigeminal) and glossopharyngeal neuralgia etc; Active oral herpes infection (simplex and zoster); History of temporomandibular arthritis; Infectious diseases, autoimmune diseases, immune deficiencies, HIV; History of allergic diseases, and organ transplantation; Diabetes and metabolic diseases; Pregnancy; Sensitivity to acetaminophen; Signs of infection or periodontal disease; History of mental and previous neurological or psychiatric problems; History of previous pain or chronic pain; History of analgesic drugs consumption; Addiction to drugs or alcohol; Unbearable pain (NRS above 7) and medication help; Early exit of separators from the space between the teeth; The history of tooth extraction from 2 weeks ago.
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
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
Research and Technology Assistance of Zahedan University of Medical Science
Street address
Zahedan University of Medical Science, Dr. Hesabi square, Zahedan
City
Zahedan
Postal code
Approval date
2013-03-12, 1391/12/22
Ethics committee reference number
91-2064
Health conditions studied
1
Description of health condition studied
Orthodontic pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
pain
Timepoint
0, 1, 6, 12, 24, 48 hours after separator placement
Method of measurement
By individual participants is determined by the numeric rating scale (NRS). 0 = no pain to 10 = worst pain imaginable
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: Under laser irradiation, and the use of placebo drug
Category
Placebo
2
Description
Group 2: the laser off and the use of Acetaminophen
Category
Treatment - Drugs
3
Description
Group 3: Under laser irradiation, and the use of Acetaminophen
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Spesialized clinic of Zahedan Dental University
Full name of responsible person
Dr. Fariba Shahri
Street address
Zahedan Dental College, Mehr street, Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Assistance of Zahedan University of Medical Science
Full name of responsible person
Dr. Hamid Reza Mahmood Zade Sagheb
Street address
Zahedan University of Medical Science, Dr Hesabi square, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Assistance of Zahedan University of Medical Science
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
Zahedan University of Medical Sciense
Full name of responsible person
Adel Sharifi Rayeni
Position
Dentistry student
Other areas of specialty/work
Street address
Fajr dormitory, Dental college, Mehr Street, Zahedan
City
Zahedan
Postal code
Phone
+98 54 1244 1824
Fax
Email
Sharifi.R.Adel@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciense
Full name of responsible person
Doctor Fariba Shahri
Position
Orthodontics Specialist
Other areas of specialty/work
Street address
Orthodontics department, Dental college, Mehr street, Zahedan
City
Zahedan
Postal code
Phone
+98 54 1242 0940
Fax
Email
Shahri_far@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciense
Full name of responsible person
Ael Sharifi Rayeni
Position
Dental student
Other areas of specialty/work
Street address
Fajr dormitory, Dental college, Mehr street, Zahedan
City
Zahedan
Postal code
Phone
+98 54 1244 1824
Fax
Email
Sharifi.R.Adel@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)