Class II Division 1 Malocclusion Clinical Trial
Official title:
Assessment of the Levels of Pain and Discomfort Associated With Corticotomy-assisted Retraction of the Anterior Maxillary Teeth Using Two Different Corticotomy Techniques. A Randomized Controlled Clinical Trial.
Verified date | June 2023 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aimed to evaluate the levels of pain, discomfort, and functional impairment associated with traditional corticotomy and flapless corticotomy in the retraction of upper anterior teeth. 40 patients requiring extraction of maxillary first premolars and maximum anchorage to retract the upper anterior teeth will participate in the study. They will be divided randomly into two groups: flapless corticotomy (20 patients) and traditional corticotomy (20 patients).
Status | Completed |
Enrollment | 40 |
Est. completion date | May 15, 2020 |
Est. primary completion date | October 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years to 28 Years |
Eligibility | Inclusion Criteria: 1. Adult healthy patients 2. Class II Division 1 malocclusion : - Mild/moderate skeletal Class II (sagittal discrepancy angle =7) - Overjet =10 - Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle) - Mild to moderate crowding = 4 3. Permanent occlusion. 4. Existence of all the upper teeth (except third molars). 5. Good oral and periodontal health: - Probing depth < 4 mm - No radiographic evidence of bone loss. - Gingival index = 1 - Plaque index = 1 Exclusion Criteria: 1. Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs)) 2. Presence of primary teeth in the maxillary arch 3. Missing permanent maxillary teeth (except third molars). 4. Poor oral hygiene or Current periodontal disease: - Probing depth = 4 mm - radiographic evidence of bone loss - Gingival index > 1 - Plaque index > 1 5. Previous orthodontic treatment |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | Orthodontics Department, Faculty of Dentistry, 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 | Patients will be asked this question about their feeling of pain (Item no 01): 'What is the degree of pain you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient. | After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days | |
Primary | Change in the levels of discomfort | Patients will be asked this question about their feeling of discomfort: 'What is the degree of discomfort you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no discomfort- 100: the worst discomfort). The score will be determined by measuring the distance from the beginning until the point identified by the patient. | After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days | |
Primary | Change in the perception of swelling | Patients will be asked this question about their feeling of swelling: 'What is the degree of swelling you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no swelling- 100: the worst swelling). The score will be determined by measuring the distance from the beginning until the point identified by the patient. | After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days | |
Primary | Change in the levels of chewing difficulty | 'What is the degree of mastication difficulties you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no difficulty- 100: too much difficulty). The score will be determined by measuring the distance from the beginning until the point identified by the patient. | After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days | |
Primary | Change in the levels of swallowing difficulty | Patients will be asked this question about their feeling of swallowing: 'What is the degree of swallowing difficulties you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no difficulty- 100: the worst difficulty). The score will be determined by measuring the distance from the beginning until the point identified by the patient. | After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days | |
Primary | Change in the levels of jaw movement restriction | Patients will be asked this question about their feeling about the jaw movement restriction: 'What is the degree of the jaw movement restriction you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no restriction- 100: maximum restriction). The score will be determined by measuring the distance from the beginning until the point identified by the patient. | After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days | |
Primary | Level of satisfaction | Patients will be asked this question about their satisfaction level: 'What is your level of satisfaction on the orthodontic treatment provided?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no satisfaction- 100: the highest satisfaction). The score will be determined by measuring the distance from the beginning until the point identified by the patient. | This outcome will be assessed at 28 days following the surgical intervention | |
Primary | The more discomfort procedure between two interventions | Patients will be asked this question: (Which surgical intervention was more discomfort ("extraction of premolars" or "the surgical procedure for acceleration"?) Assessment will be performed using a three-point scale: 1- premolar extraction, 2- surgical procedure, or 3-the same. | This outcome will be assessed at 28 days following the surgical intervention | |
Primary | The willingness to undergo this procedure again | Patients would be asked this question about the possibility of repeating the surgical procedure if they had to make the decision again: 'Would you accept to undergo this treatment again?' Assessment will be performed using a two-point scale: Yes/No. | This outcome will be assessed at 28 days following the surgical intervention |
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