Clinical trial NCT06895083: Comparison of Self-ligating Mico One and Conventional MBT Brackets Regarding Alignment Efficiency and Pain Experience- a Randomized Clinical Trial
Official title: Comparison of Self-ligating Mico One and Conventional MBT Brackets Regarding Alignment Efficiency and Pain Experience- a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: alignment efficiency and pain experience
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
Collaborators: name: Foundation University Islamabad
First posted: 2025-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blind, randomized parallel-arm study with two arms. Participants will be randomly assigned to either receive self ligating brackets or conventional brackets regarding Alignment efficiency and pain experience.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The rate of Orthodontic tooth movement affects the efficacy and time duration of the treatment. One of the key factors, during the initial alignment phase, is the amount of the force that the arch-wire applies to the dentition. The amount of the applied force and the rate of tooth movement are directly proportional to the frictional resistance between the arch wire and bracket. The quality and degree of resistance is related to the physical characteristics of the arch wire, bracket material, arch wire dimensions, and the type of arch wire ligation. The estimated rate of tooth movement is about 0.35 to 2.04 mm per month, which is influenced by various factors and variables including the biological response of the individual to orthodontic forces, the complexity of the case, treatment mechanics and patient compliance throughout the course of treatment .

Detailed description: To compare the alignment efficiency and pain experience of Mico-one self-ligating and conventional ligating MBT pre-adjusted brackets in the initial alignment stage of patients undergoing orthodontic treatment.CONVENTIONAL MBT BRACKETS: In conventional brackets elastic ligatures or metal ties are used to ligate the wire in the bracket slot. 2. SELF-LIGATING BRACKETS: Self-ligating brackets like conventional braces are placed relatively the same way.

The exception is that self-ligating braces don't use elastics, or metal ties. Instead it has special clips or brackets with a spring-loaded door. The brackets while maintaing pressure on the archwire, help move the teeth along it at a steady pace .\[9\] 3 .ALIGNMENT EFFICIENCY Movement of the teeth measured at four months interval. Scoring method involves measuring the linear distance between anatomical contact points between maxillary and mandibular incisors from adjacent tooth anatomical points. (Little's irregularity index)

4.PAIN Unpleasant sensory and emotional experience associated with tooth movement will be measured as a mean using the VAS at 4 hours, 24 hours, day 3, day 7, 1 st Month, 2 nd Month, 3 rd Month and 4 th Month.

Eligibility criteria: Inclusion Criteria

* Patients with Non extraction orthodontic treatment plan
* Crowding of 3 to 6 mm according to Little's irregularity index
* Both male and female patients
* 14-20 years of age.
* All permanent teeth present up to first permanent molar

Exclusion Criteria:

* Poor oral hygiene
* Systemic disease
* Patients with periodontally compromised teeth
* Patient requiring Orthognathic surgery to correct skeletal discrepancies
* Patients taking medications, like NSAIDs or other anti-inflammatory drugs
* Cleft lip or palate
* Hypodontia, or Hyperdontia

Primary outcomes:
measure: Alignment efficiency
timeFrame: 4 months
Secondary outcomes:
measure: Pain with tooth movement
timeFrame: Four months
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Zainab Butt
state: Federal
Study officials:
References:
citation: 1. Wagner D, Lévy-Benichou H, Lefebvre F, Bolender Y. [Are self-ligating brackets more efficient than conventional brackets ? A meta-analysis of randomized controlled and split-mouth trials]. L' Orthodontie Francaise. 2020 Dec;91(4):303-321 2. Tantidhnazet S, Leehathorn P, Rattanasumawong S, Santiwong P. Comparison of self-ligating bracket and conventional bracket in orthodontic treatment: A systematic review. M Dent J 2018; 38: 213-228 3. Dehbi H, Azaroual MF, Zaoui F, Halimi A, Benyahia H. Therapeutic efficacy of self-ligating brackets: A systematic review. Int Orthod. 2017 Sep;15(3):297-311. 4. 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. 5. Galvão MCS, Sato JR, Coelho EC. Dahlberg formula - a novel approach for its evaluation. Dental Press J Orthod. 2012;17(1):115-24.)