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Completed

NCT Number: NCT03400111

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

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.

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Key information

Conditions

Pain and Discomfort Neurologic Manifestations Orthodontic Appliance Complication Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, University of Damascus Dental School

Damascus, DM20AM18, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low-Level Laser Therapy

Radiation

low-level laser therapy will be used to relieve pain and discomfort during orthodontic treatment at specific time points.

Panadol-extra

Drug

Tablets of 565-mg Panadol-extra will be used at specific time points to control pain and discomfort

Primary outcomes

  1. 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).

  2. 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'.

  3. 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'.

  4. 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'.

  5. 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'.

  6. 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'.

  7. 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'.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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'.

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 17, 2018
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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