Evaluation of the effects of low-level laser therapy and laser acupuncture on reducing orthodontic pain
Design
This clinical trial has 2 intervention groups and 1 control group.
The trial will be one-way blind, randomized, phase 2 and on 45 people.
Patients will be randomly divided into one of three groups using triple blocks.
Settings and conduct
In this study, patients referred to private clinics of Birjand who are undergoing orthodontic treatment will be invited to participate in the trial. This study will be a single-blind randomized clinical trial in which patients will not be informed whether they are in the treatment or placebo group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are treated for the first time using a fixed appliance; Had no systemic diseases; Had fully erupted permanent teeth; Had no chronic or neural pain. The exclusion criteria: Patients who are pregnant; patients who use systemic medications (analgesics, antibiotics, anti-inflammatory drugs, antidepressants, and bisphosphonates); patients with pathological conditions associated with teeth, gingiva, or periodontium.
Intervention groups
Intervention group 1 (low level laser therapy): A Simpler2 diode laser will be used for patients in this group. Intervention group 2 (acupuncture laser therapy): A Wiser 3 diode laser will be used for patients in this group. Control group: The laser device will be in the same position as the previous two groups, except that the device will be off.
Main outcome variables
Orthodontic treatment pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210514051292N1
Registration date:2022-05-11, 1401/02/21
Registration timing:registered_while_recruiting
Last update:2022-05-11, 1401/02/21
Update count:0
Registration date
2022-05-11, 1401/02/21
Registrant information
Name
Behzad Ghadiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3650 8135
Email address
behzad.ghadiri.14@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing low level laser therapy and laser acupuncture effects on reducing pain in orthodontic patients
Public title
Investigating the effect of laser in orthodontics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients that are treated for the first time using a fixed orthodontic appliance.
Having no systemic diseases.
Having fully erupted permanent teeth.
Having no chronic or neural pain.
Exclusion criteria:
Patients who are pregnant.
Patients who use systemic medications (analgesics, antibiotics, anti-inflammatory drugs, antidepressants, and bisphosphonates).
Patients with pathological conditions associated with teeth, gingiva, or periodontium.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with the above conditions were divided into three groups randomly and by blocking method (blocks of size 3) into one of three groups: intervention 1 and intervention 2 or control. Patients were divided into three groups: Simpler2 diode laser as group A, Wiser 3 laser diode as group B and control group as group C. First, various blocks of size 3 were created (ABC, ACB, BAC, BCA, CAB, CBA). One of these blocks was randomly selected and divided into one of three groups A, B or C according to the order mentioned in the patients' selected block. Then randomization was performed for other patients.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single-blinded in which patients are unaware that they are receiving laser therapy or placebo. In both treatment groups and placebo, the laser is placed in the same way and with the same specifications in the desired points, and the light and sound of the laser beep are on for both groups, but the radiation is done only for the treatment group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand University of Medical Sciences
Street address
Birjand University of Medical Sciences, Moalem street, Birjand
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2021-10-09, 1400/07/17
Ethics committee reference number
IR.BUMS.REC.1400.206
Health conditions studied
1
Description of health condition studied
Pain in orthodontics
ICD-10 code
G89
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
Pain score
Timepoint
Immediately, 6 hours, 12 hours, 1 day, 2 days, 3 days, 4 days and 5 days after orthodontic applique placement.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: For patients in this group, a Simpler2 diode laser (Doctor Smile Simpler, made in Italy) with a wavelength of 980 nm with a biomodeling handpiece will be used with the following parameters: 1 watt output energy, 1 cm square cross-sectional area, continuous mode ), Dose 150 joules per square centimeter, time 150 seconds in total. The laser diode will be in contact with the soft tissue.
Category
Treatment - Other
2
Description
Intervention group 2: For patients in this group, a Wiser 3 diode laser (Doctor Smile, made in Italy) with a wavelength of 808 nm with a biomodeling handpiece with the following parameters will be used: 200 mW output energy, 0.28 cm cm cross-sectional area, continuous mode continuous), energy dose 21 joules per square centimeter, time 30 seconds at each point, 8 points (points sl18-st6-st7-li4 on both sides), total time 4 minutes. The diode laser will be used in contact with the tissue.
Category
Treatment - Other
3
Description
Control group: For this group, the device is kept in the same position as the previous groups for patients, but no treatment is provided.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hossein clinic
Full name of responsible person
Behzad Ghadiri
Street address
Emam Hossein clinic, Pasdaran street, Birjand
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 2338 1705
Email
M.Dehshibi@bums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Mohammadreza Miri
Street address
Research and Technology Deputy of Birjand University of Medical Sciences, Ghafari Street, Birjand, South Khorasan
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1200
Email
research@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?