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The Role of Paracetamol-caffeine and Laser Irradiation on Controlling Pain and Discomfort During Orthodontic Treatment

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ClinicalTrials.gov Identifier: NCT03400111
Recruitment Status : Completed
First Posted : January 17, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Damascus University

Tracking Information
First Submitted Date  ICMJE January 9, 2018
First Posted Date  ICMJE January 17, 2018
Last Update Posted Date July 18, 2019
Actual Study Start Date  ICMJE September 15, 2017
Actual Primary Completion Date March 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2018)
  • 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. ]
    Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after performing the first step in orthodontic installation of the appliance, i.e. the separation stage where separators are placed between the molar teeth on both sides of the jaw and in both jaws. Separators are placed for seven days before cementing the bands (that surround the molar teeth).
  • 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. ]
    Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after banding the molars and bonding the rest of the dental arches. Brackets are to be placed and the first archwire will be engaged. Assessment will be made at this stage which is called 'First Arch Placement'.
  • 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. ]
    Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after inserting the second arch in the sequence of arches of the orthodontic treatment. Assessment will be made at this stage which is called 'Second Arch Placement'.
  • 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. ]
    Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after inserting the third arch in the sequence of arches of the orthodontic treatment. Assessment will be made at this stage which is called 'Third Arch Placement'.
  • 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. ]
    Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after inserting the fourth arch in the sequence of arches of the orthodontic treatment. Assessment will be made at this stage which is called 'Fourth Arch Placement'.
  • 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. ]
    Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after inserting the fifth (i.e. the last) arch in the sequence of arches of the orthodontic treatment. Assessment will be made at this stage which is called 'Last Arch Placement'.
  • 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. ]
    Patients will be given a rating numeric scale (RNS) to show their level of pain and discomfort after appliance removal (i.e. taking off all the braces and bands). Assessment will be made at this stage which is called 'Appliance Removal'.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03400111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2018)
  • 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. ]
    Patients will be given a questionnaire to be filled after performing the first step in orthodontic installation of the appliance, i.e. the separation stage where separators are placed between the molar teeth on both sides of the jaw and in both jaws. Separators are placed for seven days before cementing the bands (that surround the molar teeth). This questionnaire is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled with three minutes.
  • 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. ]
    Patients will be given a questionnaire to be filled after banding the molars and bonding the rest of the dental arches. Brackets are to be placed and the first archwire will be engaged. Assessment will be made at this stage which is called 'First Arch Placement'. The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled with three minutes.
  • 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. ]
    Patients will be given a questionnaire to be filled after inserting the second arch in the sequence of arches of the orthodontic treatment. Assessment will be made at this stage which is called 'Second Arch Placement'.The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled with three minutes.
  • 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. ]
    Patients will be given a questionnaire to be filled after inserting the third arch in the sequence of arches of the orthodontic treatment. Assessment will be made at this stage which is called 'Third Arch Placement'.The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled with three minutes.
  • 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. ]
    Patients will be given a questionnaire to be filled after inserting the fourth arch in the sequence of arches of the orthodontic treatment. Assessment will be made at this stage which is called 'Fourth Arch Placement'.The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled with three minutes.
  • 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. ]
    Patients will be given a questionnaire to be filled after inserting the fifth (i.e. the last) arch in the sequence of arches of the orthodontic treatment. Assessment will be made at this stage which is called 'Last Arch Placement'.The questionnaire to be used is called Oral-Health-Impact-Profile with 14 items (OHIP-14) which can be filled with three minutes.
  • 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. ]
    Patients will be given a questionnaire to be filled after appliance removal (i.e. taking off all the braces and bands). Assessment will be made at this stage which is called 'Appliance Removal'.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 9, 2018)
Psychological General Well-being [ Time Frame: One week before performing the first step in Orthodontic Appliance Installation (i.e. one week before separation) ]
Patients will be requested to fill in the Psychosocial General Well-being Index (PGWBI) before the commencement of treatment
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Role of Paracetamol-caffeine and Laser Irradiation on Controlling Pain and Discomfort During Orthodontic Treatment
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Patients in the first group will undergo active irradiation with low-level laser therapy but they will consume placebo tablets. Patients in the second group will consume real Panadol-extra tablets but they will be subjected to a placebo red-beam as if they are irradiated with a laser beam. Patients in the third group will be subjected to both placebo procedures (i.e. placebo red-beam and not low-level laser therapy and placebo tablets).
Primary Purpose: Treatment
Condition  ICMJE
  • Pain and Discomfort
  • Orthodontic Appliance Complication
Intervention  ICMJE
  • Radiation: low-level laser therapy
    low-level laser therapy will be used to relieve pain and discomfort during orthodontic treatment at specific time points.
  • Drug: Panadol-extra
    Tablets of 565-mg Panadol-extra will be used at specific time points to control pain and discomfort
Study Arms  ICMJE
  • Experimental: Low-level laser therapy
    Patients upper and lower jaws will be irradiated with low-level laser therapy at specific points on the alveolus around the teeth from the vestibular and lingual sides. This group of patients will be followed up till the end of treatment.
    Intervention: Radiation: low-level laser therapy
  • Experimental: Panadol-extra
    Patients will be given Panadol-extra (565 mg: 500 mg paracetamol and 65 mg caffeine) at specific time points to control pain and discomfort during orthodontic treatment. This group of patients will be followed up till the end of treatment.
    Intervention: Drug: Panadol-extra
  • No Intervention: Traditional Treatment
    Patients will not undergo any actual irradiation therapy or take any active tablets during orthodontic treatment.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date March 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Syrian Arab Republic
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03400111
Other Study ID Numbers  ICMJE UDDS-Ortho-03-2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Damascus University
Study Sponsor  ICMJE Damascus University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amer M Owayda, DDS MSc student in Orthodontics, University of Damascus Dental School, Damascus, Syria
Study Chair: Mohammad Y Hajeer, DDS MSc PhD Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School, Damascus, Syria
Study Director: Rashad T Murad, DDS MSc PhD Associate Professor of Toxins and Pharmaceutics , Faculty of Pharmacology, University of Damascus, Damascus, Syria
PRS Account Damascus University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP