Clinical trial NCT05416242: 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
Overall status: COMPLETED
Phase: NA
Conditions: Crowding, Tooth
Keywords: Self-Ligating Brackets
Flapless corticotomy
Severe crowding
Leveling
Aligning
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the levels of pain
timeFrame: After 24 hours; 4 days; 7 days; 14 days; 28 days
measure: Change in the levels of discomfort
timeFrame: After 24 hours; 4 days; 7 days; 14 days; 28 days
measure: Change in the Perception of swelling
timeFrame: After 24 hours; 4 days; 7 days; 14 days; 28 days
measure: Change in the difficulty of mastication
timeFrame: After 24 hours; 4 days; 7 days; 14 days; 28 days
measure: Change in the difficulty of swallowing
timeFrame: After 24 hours; 4 days; 7 days; 14 days; 28 days
measure: Change in the perception of the jaw movement restriction
timeFrame: After 24 hours; 4 days; 7 days; 14 days; 28 days
measure: The levels of satisfaction
timeFrame: This outcome will be assessed at 28 days following the beginning of treatment
measure: Recommendation of the procedure to a friend
timeFrame: This outcome will be assessed at 28 days following the beginning of treatment
measure: The possibility of repeating the procedure
timeFrame: This outcome will be assessed at 28 days following the beginning of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: University of Damascus
Study officials:
affiliation: Department of orthodontics, Damascus University, Syria
name: Heba M Al-Ibrahim, DDS,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria.
name: Mohammad Y Hajeer, DDS,MSc,PhD
role: STUDY_DIRECTOR
affiliation: Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria
name: Issam ِAlkhoury, DDS,MSc,PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.