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Completed

NCT Number: NCT05416242

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

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.

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Key information

Conditions

Crowding, Tooth Behavior Crowding Malocclusion Spatial Behavior Stomatognathic Diseases Tooth Diseases

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Damascus

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional braces

Device

MBT 0.022 perception traditional braces will be used without any acceleration method.

Self-ligating braces

Device

MBT 0.022 perception Self-ligating braces will be used without any acceleration method.

Self-ligating braces + piezocision

Procedure

Flapless corticotomy will be applied for the upper anterior teeth.

Primary outcomes

  1. Change in the levels of pain

    Time frame: 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.

  2. Change in the levels of discomfort

    Time frame: 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.

  3. Change in the Perception of swelling

    Time frame: 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.

  4. Change in the difficulty of mastication

    Time frame: 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.

  5. Change in the difficulty of swallowing

    Time frame: 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.

  6. Change in the perception of the jaw movement restriction

    Time frame: 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.

  7. The levels of satisfaction

    Time frame: 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.

  8. Recommendation of the procedure to a friend

    Time frame: 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.

  9. The possibility of repeating the procedure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Jun 13, 2022
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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