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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03400111 |
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Date of registration:
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09/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Role of Paracetamol-caffeine and Laser Irradiation on Controlling Pain and Discomfort During Orthodontic Treatment
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Scientific title:
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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 |
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Date of first enrolment:
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September 15, 2017 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03400111 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Syrian Arab Republic
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Contacts
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Name:
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Rashad T Murad, DDS MSc PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Associate Professor of Toxins and Pharmaceutics , Faculty of Pharmacology, University of Damascus, Damascus, Syria |
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Name:
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Amer M Owayda, DDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria |
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Name:
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Mohammad Y Hajeer, DDS MSc PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School, Damascus, Syria |
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Key inclusion & exclusion criteria
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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.
Age minimum:
15 Years
Age maximum:
30 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Orthodontic Appliance Complication
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Pain and Discomfort
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Intervention(s)
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Radiation: low-level laser therapy
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Drug: Panadol-extra
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Primary Outcome(s)
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Change in Levels of Pain and Discomfort_LastArch
[Time Frame: (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.]
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Change in Levels of Pain and Discomfort_FouthArch
[Time Frame: (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.]
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Change in Levels of Pain and Discomfort_ThirdArch
[Time Frame: (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.]
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Change in Levels of Pain and Discomfort_Debonding
[Time Frame: (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.]
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Change in Levels of Pain and Discomfort_Separation
[Time Frame: (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.]
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Change in Levels of Pain and Discomfort_SecondArch
[Time Frame: (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.]
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Change in Levels of Pain and Discomfort_FirstArch
[Time Frame: (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.]
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Secondary Outcome(s)
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Change in oral-health-related quality of life_LastArch
[Time Frame: (1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.]
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Change in oral-health-related quality of life_FirstArch
[Time Frame: (1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.]
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Change in oral-health-related quality of life_Debonding
[Time Frame: (1) one week following appliance removal, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.]
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Change in oral-health-related quality of life_FourthArch
[Time Frame: (1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.]
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Change in oral-health-related quality of life_ThirdArch
[Time Frame: (1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.]
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Change in oral-health-related quality of life_SecondArch
[Time Frame: (1) one week following archwire engagement, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.]
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Change in oral-health-related quality of life_Separation
[Time Frame: (1) one week following separation, (2) at the following clinical visit which is usually expected to occur within 14 to 21 days.]
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Secondary ID(s)
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UDDS-Ortho-03-2018
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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