Crowding, Tooth Clinical Trial
Official title:
Evaluation of Patient-centered Outcomes Associated With Acceleration of Lower Incisors Decrowding Using Self-ligating Brackets With and Without Piezocision in Comparison With Traditional Brackets: A Randomized Controlled Clinical Trial
Verified date | June 2022 |
Source | Damascus University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The different types of brackets (e.g., self-ligating and conventional brackets), and the various acceleration methods (e.g., corticotomy) cause varying degrees of pain and discomfort. This study will assess pain, discomfort, and other patient-centered outcomes in adults with severe crowding on the upper jaw requiring two first premolars extraction. There are three groups: The first group (control group): the patients in this group will be treated using conventional brackets alone. The second group (Experimental group): the patients in this group will be treated using self-ligating brackets alone. The third group (Experimental group): the patients in this group will be treated using self-ligating brackets associated with flapless corticotomy.
Status | Completed |
Enrollment | 63 |
Est. completion date | August 22, 2021 |
Est. primary completion date | October 7, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 28 Years |
Eligibility | Inclusion Criteria: 1. The patient's age is between 18 and 25 years 2. Severe crowding on the upper jaw (more than 6 mm) requires upper first premolars extraction 3. Little's Index of Irregularity is greater than 7 mm 4. Overbite ranging between 0-4 mm 5. Normal inclination of the upper incisors 6. No missing teeth (except for third molars) 7. Class I or class II (ANB = 5) or class III (ANB = 0) Exclusion Criteria: 1. The presence of any systemic disease affecting orthodontic movement 2. The presence of congenital syndromes or cleft lip and palate 3. Poor oral health with a plaque index greater than (1) 4. Skeletal maxillary constriction |
Country | Name | City | State |
---|---|---|---|
Syrian Arab Republic | University of Damascus | Damascus |
Lead Sponsor | Collaborator |
---|---|
Damascus University |
Syrian Arab Republic,
Fleming PS, Dibiase AT, Sarri G, Lee RT. Pain experience during initial alignment with a self-ligating and a conventional fixed orthodontic appliance system. A randomized controlled clinical trial. Angle Orthod. 2009 Jan;79(1):46-50. doi: 10.2319/121007-579.1. — View Citation
Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9. — View Citation
Jahanbin A, Hasanzadeh N, Khaki S, Shafaee H. Comparison of self-ligating Damon3 and conventional MBT brackets regarding alignment efficiency and pain experience: A randomized clinical trial. J Dent Res Dent Clin Dent Prospects. 2019 Fall;13(4):281-288. doi: 10.15171/joddd.2019.043. — View Citation
Lai TT, Chiou JY, Lai TC, Chen T, Wang HY, Li CH, Chen MH. Perceived pain for orthodontic patients with conventional brackets or self-ligating brackets over 1 month period: A single-center, randomized controlled clinical trial. J Formos Med Assoc. 2020 Jan;119(1 Pt 2):282-289. doi: 10.1016/j.jfma.2019.05.014. Epub 2019 Jun 14. — View Citation
Tecco S, D'Attilio M, Tetè S, Festa F. Prevalence and type of pain during conventional and self-ligating orthodontic treatment. Eur J Orthod. 2009 Aug;31(4):380-4. doi: 10.1093/ejo/cjp003. Epub 2009 May 22. — View Citation
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 impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue 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; 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 (Item no 02):
'What is the degree of discomfort you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue 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; 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 (Item no 03):
'What is the degree of swelling you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue 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; 4 days; 7 days; 14 days; 28 days | |
Primary | Change in the difficulty of mastication | 'What is the degree of mastication difficulties you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue 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; 4 days; 7 days; 14 days; 28 days | |
Primary | Change in the difficulty of swallowing | Patients will be asked this question about their feeling of swallowing (Item no 05):
'What is the degree of swallowing difficulties you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue 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; 4 days; 7 days; 14 days; 28 days | |
Primary | Change in the perception of the jaw movement restriction | Patients will be asked this question about their feeling of the jaw movement restriction (Item no 06):
'What is the degree of the jaw movement restriction you have experienced?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue 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; 4 days; 7 days; 14 days; 28 days | |
Primary | The levels of satisfaction | Patients will be asked this question about their levels of satisfaction (Item no 07): 'What is your levels of satisfaction on the orthodontic treatment provided?' A standardized questionnaire will be used to assess pain, discomfort and functional impairments' levels during the active phase of treatment. The patient will be asked to specify a point on the visual analogue 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 beginning of treatment | |
Primary | Recommendation of the procedure to a friend | Patients will be asked this question (Item no 08): 'Would you recommend a friend undergo this treatment?' Assessment will be performed using a two-point scale to answer yes or no. | This outcome will be assessed at 28 days following the beginning of treatment | |
Primary | The possibility of repeating the procedure | Patients will be asked this question about the possibility of repeating the procedure (Item no 09): 'Would you accept to undergo this treatment again?' Assessment will be performed using a two-point scale to answer yes or no. | This outcome will be assessed at 28 days following the beginning of treatment |
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