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A clinical trial to compare the effectiveness of ibuprofen with low-level laser on acupuncture points in pain reduction after initial archwire placement in orthodontic patient

Protocol summary

Study aim
To compare the effectiveness of ibuprofen with low-level laser on acupuncture points in pain reduction after initial archwire placement in orthodontic patient
Design
Totally, 80 patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, Mashhad, Iran. In this single-blind, controlled clinical trial, the patients are assigned into parallel groups using simple sampling methods.
Settings and conduct
Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female with aged range 14-30 years; no history of systemic disease; nonuse of analgesic. Exclusion criteria: Having drug intolerance; having gastrointestinal disorders; pregnant and lactating women; having special medical condition.
Intervention groups
Intervention group I will receive 810 nm wavelength laser with 200 mW power for 30 seconds around the 6 points area around the root of tooth after initial archwire placement. Intervention group II will receive 810 nm wavelength laser with 200 mW power for 60 seconds in 5 acupuncture points after initial archwire placement. Intervention group III will receive 400 mg ibuprofen every 8 hours after initial archwire placement. Control group will receive laser off in acupuncture points after initial archwire placement.
Main outcome variables
Evaluation and comparison of the pain rate in chewing, biting, tipping anterior teeth, and put posterior teeth on each other in 2 and 6 hours, as well as 2, 3, 5 and 7 days after the intervention in the three intervention and control groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200622047886N1
Registration date: 2020-06-29, 1399/04/09
Registration timing: prospective

Last update: 2020-06-29, 1399/04/09
Update count: 0
Registration date
2020-06-29, 1399/04/09
Registrant information
Name
Melika Hagpanahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3883 2300
Email address
ahrarif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of ibuprofen with low-level laser on acupuncture points in pain reduction after initial archwire placement in orthodontic patient
Public title
The effectiveness of low-level laser on acupuncture points in pain reduction in orthodontic patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female with aged range 14-30 years No history of systemic disease Nonuse of analgesic
Exclusion criteria:
Having drug intolerance Having gastrointestinal disorders Pregnant and lactating women Having special medical condition
Age
From 14 years old to 30 years old
Gender
Female
Phase
1
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into three groups of 20 patients with blocks of 2, 4, 6 and 8 using randomization method. A noninvolved researcher will determine the random assignment sequencing in sampling using a statistical analysis system (SAS), computer software. Accordingly, the participants were given codes and assigned into the three intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2019-11-13, 1398/08/22
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1398.103

Health conditions studied

1

Description of health condition studied
Orthodontic
ICD-10 code
Z46.4
ICD-10 code description
Fitting and adjustment of orthodontic device

Primary outcomes

1

Description
The pain rate in chewing
Timepoint
2 and 6 hours, as well as 2, 3, 5 and 7 days after the intervention
Method of measurement
Visual Analogue Scale (VAS)

2

Description
The pain rate in biting
Timepoint
2 and 6 hours, as well as 2, 3, 5 and 7 days after the intervention
Method of measurement
Visual Analogue Scale (VAS)

3

Description
The pain rate when tipping anterior teeth
Timepoint
2 and 6 hours, as well as 2, 3, 5 and 7 days after the intervention
Method of measurement
Visual Analogue Scale (VAS)

4

Description
The pain rate when put posterior teeth on each other
Timepoint
2 and 6 hours, as well as 2, 3, 5 and 7 days after the intervention
Method of measurement
Visual Analogue Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group I will receive 810 nm wavelength laser with 200 mW power for 30 seconds around the 6 points area around the root of tooth after initial archwire placement.
Category
Treatment - Other

2

Description
Intervention group: Intervention group II will receive 810 nm wavelength laser with 200 mW power for 60 seconds in 5 acupuncture points after initial archwire placement.
Category
Treatment - Other

3

Description
Intervention group: Intervention group III will receive 400 mg ibuprofen every 8 hours after initial archwire placement.
Category
Treatment - Drugs

4

Description
Control group: Control group will receive laser off in acupuncture points after initial archwire placement.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad Faculty of Dentistry Dental Clinic
Full name of responsible person
Melika Hagpanahi
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
melikah750@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashhad University of Medical Sciences
Full name of responsible person
Melika Hagpanahi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
melikah750@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Melika Hagpanahi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Fax
Email
melikah750@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Melika Hagpanahi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3883 2300
Email
melikah750@gmail.com

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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The total data to be included are the primary and secondary effects to be shared.
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working in science center and university.
Under which criteria data/document could be used
Our data will be available for scholars working in science center and university.
From where data/document is obtainable
Melika Hagpanahi provides the analysis code to the applicants via email: melikah750@gmail.com
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.
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