Clinical trial NCT03400111: The Role of Paracetamol-caffeine and Laser Irradiation on Controlling Pain and Discomfort During Orthodontic Treatment
Official title: Assessment of Low-level Laser Therapy Versus Paracetamol-caffeine Efficacy in Controlling Pain During Fixed Orthodontic Treatment and Their Role in Enhancing Oral-health-related Quality of Life: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain and Discomfort
Orthodontic Appliance Complication
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with class I malocclusion who have mild to moderate crowding will be treated in this study. The efficacy of low level laser therapy and Panadol-extra® in relieving pain due to orthodontic treatment will be assessed. The effect of these two interventions on oral-health related quality of life during all stages of orthodontic treatment will be explored, i.e. at the following stages: (1) separation between teeth, (2) archwire changing, (3) bonding of brackets, (4) removal of the fixed appliances.

There are three groups :

1. a group of patient being irradiated with low-level laser therapy (LLLT) at specific time points to relieve pain and discomfort.
2. a group of patient in which pain control will be accomplished by prescribing Panadol Extra tablets in a regular manner.
3. a group of patients in which nothing will be given to them during the course of treatment.

Detailed description: The assessment of oral-health-related quality of life during the different stages of orthodontic treatment is probably unique in the literature.

The study will cover the different stages of orthodontic treatment from A to Z. In other words, patients will be followed up till the end of treatment at which fixed appliances are removed. Pain control will be accomplished in one arm using LLLT and in another arm by prescribing Panadol Extra®. A third group will be left without any medication or laser irradiation to serve as a control group.

Eligibility criteria: Inclusion Criteria:

* Class I malocclusion with mild to moderate crowding (2-5 mm of tooth-size-arch-length-discrepancy)..
* Good oral hygiene and periodontal health
* No need for any preparation for fixed orthodontic appliance.
* No severe skeletal discrepancy (i.e. Class I skeletal relationship).

Exclusion Criteria:

* Previous orthodontic treatment
* Patients with psychological abnormalities.
* Patients with systematic diseases or being treated from chronic pain or headache.

Primary outcomes:
measure: Change in Levels of Pain and Discomfort_Separation
timeFrame: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
measure: Change in Levels of Pain and Discomfort_FirstArch
timeFrame: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
measure: Change in Levels of Pain and Discomfort_SecondArch
timeFrame: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
measure: Change in Levels of Pain and Discomfort_ThirdArch
timeFrame: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
measure: Change in Levels of Pain and Discomfort_FouthArch
timeFrame: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
measure: Change in Levels of Pain and Discomfort_LastArch
timeFrame: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
measure: Change in Levels of Pain and Discomfort_Debonding
timeFrame: (1) one hour following insertion of separators, (2) 24 hours, (3) 2 days, (4) seven days, (5) next meeting which is expected to be within 14 to 21 days.
Secondary outcomes:
measure: Change in oral-health-related quality of life_Separation
timeFrame: (1) one week following separation, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.
measure: Change in oral-health-related quality of life_FirstArch
timeFrame: (1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.
measure: Change in oral-health-related quality of life_SecondArch
timeFrame: (1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.
measure: Change in oral-health-related quality of life_ThirdArch
timeFrame: (1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.
measure: Change in oral-health-related quality of life_FourthArch
timeFrame: (1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.
measure: Change in oral-health-related quality of life_LastArch
timeFrame: (1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.
measure: Change in oral-health-related quality of life_Debonding
timeFrame: (1) one week following appliance removal, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.
Other outcomes:
measure: Psychological General Well-being
timeFrame: One week before performing the first step in Orthodontic Appliance Installation (i.e. one week before separation)
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, University of Damascus Dental School
Study officials:
affiliation: MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria
name: Amer M Owayda, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School, Damascus, Syria
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_CHAIR
affiliation: Associate Professor of Toxins and Pharmaceutics , Faculty of Pharmacology, University of Damascus, Damascus, Syria
name: Rashad T Murad, DDS MSc PhD
role: STUDY_DIRECTOR
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