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

NCT ID: NCT06895083

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2025-03-10

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

conventional

Participants in this arm will conventional brackets

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental

Participants in this arm will self ligating brackets

Group Type: EXPERIMENTAL

self ligating brackets

Intervention Type: OTHER

selfligating are new brackets

Interventions

self ligating brackets

selfligating are new brackets

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: collaborator

Shoaib Rahim

OTHER

Sponsor Role: lead

Responsible Party

Shoaib Rahim

Assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zainab Butt

Islamabad, Federal, Pakistan

Countries

Pakistan

References

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.)

Reference Type: BACKGROUND

Other Identifiers

FF/FUMC/215-329Phy/23

Identifier Type: -

Identifier Source: org_study_id