Patient-centered Outcomes During Using Self-ligating Brackets With or Without Piezocision vs Traditional Brackets

Not Applicable

Completed

• Conditions: Crowding, Tooth
• Interventions: Device: Traditional braces; Procedure: Self-ligating braces + piezocision; Device: Self-ligating braces

• Registration Number: NCT05416242
• Lead Sponsor: Damascus University

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.

Study Timeline

• Study Start: 2019-04-14
• Primary Completion: 2020-10-07
• Study Completion: 2021-08-22
• Status Verified: 2022-06
• Study First Submitted: 2022-06-05
• Study First Submitted QC: 2022-06-08
• Last Update Submitted: 2022-06-10
• Study First Posted: 2022-06-13
• Last Update Posted: 2022-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed appliance	Traditional braces	Patients in this group will be treated using traditional brackets alone.
Self-ligaton appliance + piezocision	Self-ligating braces + piezocision	Patients in this group will be treated using self-ligating brackets associated with piezocision.
Self-ligaton appliance	Self-ligating braces	Patients in this group will be treated using self-ligating brackets alone.

Primary Outcome Measures

Name	Time	Method
Change in the difficulty of mastication	After 24 hours; 4 days; 7 days; 14 days; 28 days	'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.
Recommendation of the procedure to a friend	This outcome will be assessed at 28 days following the beginning of treatment	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.
Change in the perception of the jaw movement restriction	After 24 hours; 4 days; 7 days; 14 days; 28 days	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.
Change in the levels of discomfort	After 24 hours; 4 days; 7 days; 14 days; 28 days	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	After 24 hours; 4 days; 7 days; 14 days; 28 days	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 swallowing	After 24 hours; 4 days; 7 days; 14 days; 28 days	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 levels of pain	After 24 hours; 4 days; 7 days; 14 days; 28 days	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.
The levels of satisfaction	This outcome will be assessed at 28 days following the beginning of treatment	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.
The possibility of repeating the procedure	This outcome will be assessed at 28 days following the beginning of treatment	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.

Trial Locations

Locations (1)

University of Damascus; 🇸🇾 Damascus, Syrian Arab Republic