Crowding, Tooth Clinical Trial
Official title:
The Effect of Corticision on Perceived Pain and Discomfort for Patients With Crowded Lower Anterior Teeth in Young Adult Patients: Randomized Clinical Trial
Verified date | February 2022 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods. Researches used minimally invasive surgical methods like corticision, piezocesion, disicion, micro-osteoperforation, and piezopuncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods. Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.
Status | Completed |
Enrollment | 52 |
Est. completion date | August 26, 2020 |
Est. primary completion date | January 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 24 Years |
Eligibility | Inclusion Criteria: 1. Age range between 18 and 24 years 2. Completion of permanent dentition (except third molars) 3. Mild to moderate crowding (2-6 mm according to Little's index) 4. Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment Exclusion Criteria: 1. Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery 2. Medical conditions that affect tooth movement (Corticosteroid, NSAIDs) 3. Patients had previous orthodontic treatments 4. Poor oral hygiene or concurrent periodontal disease |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | University of Damascus | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the levels of pain | Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced. The left end of the line refers to no pain (VAS=0) where the right end refers to maximum (unimaginable) pain (VAS=100). The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain. | at 1, 7, 14 days following the onset of orthodontic treatment | |
Primary | Change in the levels of discomfort: | discomfort is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of discomfort being experienced. The left end of the line refers to no discomfort (VAS=0) where the right end refers to maximum discomfort (VAS=100). The level of discomfort is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the discomfort. | at 1, 7, 14 days following the onset of orthodontic treatment | |
Primary | Change in the levels of swelling | swelling is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of swelling being experienced. The left end of the line refers to no swelling (VAS=0) where the right end refers to maximum swelling (VAS=100). The level of swelling is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the swelling. | at 1, 7, 14 days following the onset of orthodontic treatment | |
Primary | Change in the perception of mastication problems: | difficulties of mastication are assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulties in mastication being experienced. The left end of the line refers to no difficulties (VAS=0) where the right end refers to maximum difficulties (VAS=100). The level of difficulties in mastication are represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the difficulties of mastication. | at 1, 7, 14 days following the onset of orthodontic treatment | |
Primary | Number of analgesic tables taken | The number of tablets used: Patients in both groups were asked about taking analgesics and their quantity (mg) They answered about taking analgesics using a two-point scale (1. Yes or 2. No), and their quantity by mentioning how many tablets they took. | at seven days following the onset of orthodontic treatment | |
Secondary | Satisfaction using VAS: | Definition: satisfaction is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of satisfaction. The left end of the line refers to no satisfaction (VAS=0) where the right end refers to maximum satisfaction (VAS=100). The level of satisfaction is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the satisfaction. | At the end of leveling and alignment | |
Secondary | Satisfaction with the ease of the procedure | is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of ease. The left end of the line refers to no ease (VAS=0) where the right end refers to maximum ease (VAS=100). The grade of ease is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the ease of the procedure. | At the end of leveling and alignment | |
Secondary | Satisfaction through acceptability of the procedure | Patients in corticision group were asked about possibility of repeating the procedure, and they answered using a two-point scale (1. Yes or 2. No). | At the end of leveling and alignment | |
Secondary | Satisfaction through recommending the procedure | Recommendation to a friend: Patients in corticision group were asked about making recommendation to a friend, and they answered using a two-point scale (1. Yes or 2. No). | At the end of leveling and alignment |
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