Comparison of Self-ligating Mico One and Conventional MBT Brackets Regarding Alignment Efficiency and Pain Experience- a Randomized Clinical Trial

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 .

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: self ligating brackets

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 44000
      • Zainab Butt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: conventional; Participants in this arm will conventional brackets
Experimental: Experimental; Participants in this arm will self ligating brackets	Other: self ligating brackets; selfligating are new brackets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alignment efficiency	amount of tooth movement in millimeters	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain with tooth movement	pain perception using visual analogue scale with Zero equivalent to no pain and 10 indicates the worst possible pain	Four months

Collaborators and Investigators

• Sponsor: Shoaib Rahim
• Collaborators: Foundation University Islamabad

Publications and helpful links

General Publications

• 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.)

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2023
• Primary Completion (Actual): February 10, 2025
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: alignment efficiency and pain experience
• Other Study ID Numbers: FF/FUMC/215-329Phy/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No