NCT06895083

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
Last Updated

March 26, 2025

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

March 19, 2025

Last Update Submit

March 19, 2025

Conditions

Pain

Keywords

alignment efficiency and pain experience

Outcome Measures

Primary Outcomes (1)

  • Alignment efficiency

    amount of tooth movement in millimeters

    4 months

Secondary Outcomes (1)

  • Pain with tooth movement

    Four months

Study Arms (2)

conventional

NO INTERVENTION

Participants in this arm will conventional brackets

Experimental

EXPERIMENTAL

Participants in this arm will self ligating brackets

Other: self ligating brackets

Interventions

self ligating bracketsOTHER

selfligating are new brackets

Experimental

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zainab Butt

Islamabad, Federal, 44000, Pakistan

Location

Related Publications (1)

  • 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.)

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Interventional or control group will be selected randomly through sealed envelope by an independent researcher not involved in the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 19, 2025

First Posted

March 26, 2025

Study Start

September 30, 2023

Primary Completion

February 10, 2025

Study Completion

March 10, 2025

Last Updated

March 26, 2025

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

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.

Locations

PA(1)