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

NCT05416242 | Completed DMC

• 1 other identifier: UDDS-Ortho-11-2022
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Crowding, Tooth

Keywords

Self-Ligating Brackets; Flapless corticotomy; Severe crowding; Leveling; Aligning

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Fixed appliance

ACTIVE COMPARATOR

Patients in this group will be treated using traditional brackets alone.

Device: Traditional braces

Self-ligaton appliance

EXPERIMENTAL

Patients in this group will be treated using self-ligating brackets alone.

Device: Self-ligating braces

Self-ligaton appliance + piezocision

EXPERIMENTAL

Patients in this group will be treated using self-ligating brackets associated with piezocision.

Procedure: Self-ligating braces + piezocision

Interventions

Traditional braces DEVICE

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

Fixed appliance

Self-ligating braces DEVICE

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

Self-ligaton appliance

Self-ligating braces + piezocision PROCEDURE

Flapless corticotomy will be applied for the upper anterior teeth.

Self-ligaton appliance + piezocision

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

University of Damascus

Damascus, Syria

Location

Related Publications (5)

• 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.

  PMID: 32190212 BACKGROUND

• 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.

  PMID: 19123718 BACKGROUND

• 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.

  PMID: 30991984 BACKGROUND

• 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.

  PMID: 31208826 BACKGROUND

• 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.

  PMID: 19465738 BACKGROUND

MeSH Terms

Conditions

Malocclusion; Crowding

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Spatial Behavior; Behavior

Study Officials

• Heba M Al-Ibrahim, DDS,MSc

  Department of orthodontics, Damascus University, Syria

  PRINCIPAL INVESTIGATOR

• Mohammad Y Hajeer, DDS,MSc,PhD

  Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria.

  STUDY DIRECTOR

• Issam ِAlkhoury, DDS,MSc,PhD

  Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 13, 2022
• Study Start: April 14, 2019
• Primary Completion: October 7, 2020
• Study Completion: August 22, 2021
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)