Patient-centered Outcomes During Using Self-ligating Brackets With or Without Piezocision vs Traditional Brackets
Primary Purpose
Crowding, Tooth
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Traditional braces
Self-ligating braces
Self-ligating braces + piezocision
Sponsored by
About this trial
This is an interventional treatment trial for Crowding, Tooth focused on measuring Self-Ligating Brackets, Flapless corticotomy, Severe crowding, Leveling, Aligning
Eligibility Criteria
Inclusion Criteria:
- The patient's age is between 18 and 25 years
- Severe crowding on the upper jaw (more than 6 mm) requires upper first premolars extraction
- Little's Index of Irregularity is greater than 7 mm
- Overbite ranging between 0-4 mm
- Normal inclination of the upper incisors
- No missing teeth (except for third molars)
- Class I or class II (ANB ≤ 5) or class III (ANB ≥ 0)
Exclusion Criteria:
- The presence of any systemic disease affecting orthodontic movement
- The presence of congenital syndromes or cleft lip and palate
- Poor oral health with a plaque index greater than (1)
- Skeletal maxillary constriction
Sites / Locations
- University of Damascus
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Fixed appliance
Self-ligaton appliance
Self-ligaton appliance + piezocision
Arm Description
Patients in this group will be treated using traditional brackets alone.
Patients in this group will be treated using self-ligating brackets alone.
Patients in this group will be treated using self-ligating brackets associated with piezocision.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05416242
Brief Title
Patient-centered Outcomes During Using Self-ligating Brackets With or Without Piezocision vs Traditional Brackets
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
April 14, 2019 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
August 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Pain associated with orthodontic treatment is one of the undesirable complications, which negatively affects the patient's cooperation. Pain may occur due to the pressure on the periodontal ligaments induced by orthodontic forces. The perception of pain is affected by many factors related to the patient, such as age, gender and any previous treatment experiences, which are negatively or positively reflected on the patient's cooperation. As for the factors related to the type of orthodontic treatment provided, the pain and discomfort are proportional to the brackets system used and the forces applied, especially in the leveling and alignment stage. The amount of tooth movement is directly affected by the friction between the brackets and the wires used. The physical properties of the wire and brackets used and the dimensions of the applied wires, in addition to the type of ligation play a significant role in the amount of friction generated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crowding, Tooth
Keywords
Self-Ligating Brackets, Flapless corticotomy, Severe crowding, Leveling, Aligning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fixed appliance
Arm Type
Active Comparator
Arm Description
Patients in this group will be treated using traditional brackets alone.
Arm Title
Self-ligaton appliance
Arm Type
Experimental
Arm Description
Patients in this group will be treated using self-ligating brackets alone.
Arm Title
Self-ligaton appliance + piezocision
Arm Type
Experimental
Arm Description
Patients in this group will be treated using self-ligating brackets associated with piezocision.
Intervention Type
Device
Intervention Name(s)
Traditional braces
Intervention Description
MBT 0.022 perception traditional braces will be used without any acceleration method.
Intervention Type
Device
Intervention Name(s)
Self-ligating braces
Intervention Description
MBT 0.022 perception Self-ligating braces will be used without any acceleration method.
Intervention Type
Procedure
Intervention Name(s)
Self-ligating braces + piezocision
Intervention Description
Flapless corticotomy will be applied for the upper anterior teeth.
Primary Outcome Measure Information:
Title
Change in the levels of pain
Description
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.
Time Frame
After 24 hours; 4 days; 7 days; 14 days; 28 days
Title
Change in the levels of discomfort
Description
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.
Time Frame
After 24 hours; 4 days; 7 days; 14 days; 28 days
Title
Change in the Perception of swelling
Description
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.
Time Frame
After 24 hours; 4 days; 7 days; 14 days; 28 days
Title
Change in the difficulty of mastication
Description
'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.
Time Frame
After 24 hours; 4 days; 7 days; 14 days; 28 days
Title
Change in the difficulty of swallowing
Description
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.
Time Frame
After 24 hours; 4 days; 7 days; 14 days; 28 days
Title
Change in the perception of the jaw movement restriction
Description
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.
Time Frame
After 24 hours; 4 days; 7 days; 14 days; 28 days
Title
The levels of satisfaction
Description
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.
Time Frame
This outcome will be assessed at 28 days following the beginning of treatment
Title
Recommendation of the procedure to a friend
Description
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.
Time Frame
This outcome will be assessed at 28 days following the beginning of treatment
Title
The possibility of repeating the procedure
Description
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.
Time Frame
This outcome will be assessed at 28 days following the beginning of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient's age is between 18 and 25 years
Severe crowding on the upper jaw (more than 6 mm) requires upper first premolars extraction
Little's Index of Irregularity is greater than 7 mm
Overbite ranging between 0-4 mm
Normal inclination of the upper incisors
No missing teeth (except for third molars)
Class I or class II (ANB ≤ 5) or class III (ANB ≥ 0)
Exclusion Criteria:
The presence of any systemic disease affecting orthodontic movement
The presence of congenital syndromes or cleft lip and palate
Poor oral health with a plaque index greater than (1)
Skeletal maxillary constriction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heba M Al-Ibrahim, DDS,MSc
Organizational Affiliation
Department of orthodontics, Damascus University, Syria
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad Y Hajeer, DDS,MSc,PhD
Organizational Affiliation
Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Issam ِAlkhoury, DDS,MSc,PhD
Organizational Affiliation
Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria
Official's Role
Study Director
Facility Information:
Facility Name
University of Damascus
City
Damascus
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32190212
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.
Results Reference
background
PubMed Identifier
19123718
Citation
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.
Results Reference
background
PubMed Identifier
30991984
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.
Results Reference
background
PubMed Identifier
31208826
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.
Results Reference
background
PubMed Identifier
19465738
Citation
Tecco S, D'Attilio M, Tete 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.
Results Reference
background
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Patient-centered Outcomes During Using Self-ligating Brackets With or Without Piezocision vs Traditional Brackets
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