The Comparison of Efficacy of Pharmacological (Iboprofen) with Non-Pharmacological (Photobiomodulation and Chewing Gum) Interventions on Reducing Pain in Teeth with Elastomeric Separators
Determination Of The Effect Of Drug Interventions (Ibuprofen) With Non-Pharmacological (Photomodenation And Chewing Gum) On Pain Associated With Elastomeric Separator
Design
Clinical trial, with parallel groups, single-blind, randomized, phase 3 on 90 patients. The RANDBETWEEN function of Excel software was used for randomization.
Settings and conduct
In this randomized clinical trial study, about 90 patients requiring an elastomeric spacer on the right side of the mandible were included in the study. Ibuprofen, laser, and chewing gum were used to reduce pain. Patients are given a McGill Pain Questionnaire to report their pain. This study is designed to be one-sided blind. Due to the nature of the interventions, it is not possible to blind the patient, but the outcome assessor has no Information of the study hypothesis and how the study groups are assigned.
Participants/Inclusion and exclusion criteria
Patients Need Elastomeric Separators
Dental Tight Contact
No Systemic Disease And Use Of Painkillers
Intervention groups
Ibuprofen, chewing gum, PBMT groups
Main outcome variables
The main outcome of this study is pain, which is measured by using the McGill Pain Questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210927052611N1
Registration date:2022-03-14, 1400/12/23
Registration timing:registered_while_recruiting
Last update:2022-03-14, 1400/12/23
Update count:0
Registration date
2022-03-14, 1400/12/23
Registrant information
Name
Maryam Malekpour salimezadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3823 1196
Email address
m_malekpour83@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-09, 1400/12/18
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of Efficacy of Pharmacological (Iboprofen) with Non-Pharmacological (Photobiomodulation and Chewing Gum) Interventions on Reducing Pain in Teeth with Elastomeric Separators
Public title
The Comparison of Ibuprofen, Chewing Gum and laser in orthodontic pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female patients between 30 and 15 years old seeking fixed orthodontic treatment
No pain in the mouth (teeth and gums) when starting the study
The first molar teeth are fully erupted
Presence of the first molar teeth in the opposite arch interproximal
tight contact between teeth adjacent to the first molar
irregularity index more than 2 mm
No previous tooth restoration, root canal treatment and periodontal disease in the examined tooth
Exclusion criteria:
Failure to complete or incomplete form of informed consent or VAS questionnaire
Take painkillers and other painkillers the day before the separators are placed
smoking
Pregnancy and Breastfeeding
PBM usage history
Detachment of one or more elastomeric separators
Lack of second premolars or second molars in the arch
Participants with a pain threshold higher (greater than 1500 g) or lower (less than 500 g)
Age
From 15 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
A Table of Random Numbers is Used For Randomization. In Excel Software Environment, Four-Digit Codes Are Generated Using The RANDBETWEEN Command. Each Patient Is Assigned A 4-Digit Code. If The Far Right Digit Is 1, 2, And 3, The Patient Is In The Photobiomodulation Group, Numbers 4, 5, And 6 Is Assigned In The Chewing Gum Group And Eventually Numbers 7, 8, And 9 Is Assigned In The Ibuprofen Group. Zero Does Not Count In Encodings. All Codes Are Are Written On Paper And Stored In Specific Envelopes. The Envelopes Are Arranged Randomly And The Responsible Secretary, Who Is Aware Of The Objectives Of The Study, Will Give Them One Of These Envelopes Before Entering The Doctor's Room When Reviewing The Inclusion Criteria And Recording Patient Information. The Secretary Is Not Aware Of The Study Hypothesis And Is Not Aware Of The Details Of The Codes For Assigning To Groups. The Doctor Will Decide On The Treatment Process For The Patient Based On The Specified Code.
Blinding (investigator's opinion)
Single blinded
Blinding description
This Study Is Designed To Be One-Sided Blind. Due To The Nature Of The Interventions, It Is Not Possible To Blind The Patient, But The Outcome Assessor Has No Knowledge Of The Study Hypothesis And How The Study Groups Are Assigned.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences