Orthodontic Appliance Complication, Pain and Discomfort
Conditions
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.
Interventions
RADIATIONlow-level laser therapy
low-level laser therapy will be used to relieve pain and discomfort during orthodontic treatment at specific time points.
DRUGPanadol-extra
Tablets of 565-mg Panadol-extra will be used at specific time points to control pain and discomfort
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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).
Eligibility
Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Levels of Pain and Discomfort_Debonding | (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'. |
| Change in Levels of Pain and Discomfort_Separation | (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 | (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 | (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 | (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 | (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 | (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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in oral-health-related quality of life_Debonding | (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'. |
| Change in oral-health-related quality of life_Separation | (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 | (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 | (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 | (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 | (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 | (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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Psychological General Well-being | 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 |
Countries
Syria
Outcome results
None listed