Assessment of Maxillary Canine Retraction Using Self-ligating Brackets System Assisted With Micro-osteoperforations

Assessment of Maxillary Canine Retraction Using Self-ligating Brackets System Assisted With Micro-osteoperforations: A Prospective Controlled Clinical Study

Assessment of maxillary canine retraction using self-ligating brackets system assisted with micro-osteoperforations: A prospective controlled clinical study

Study Overview

• Status: Enrolling by invitation
• Conditions: Accerleration of Tooth Movement
• Intervention / Treatment: Biological: self ligating bracket with micro osteoperforation; Biological: conventional bracket with micro osteoperforation; Biological: conventional bracket without micro osteoperforation; Biological: self ligating bracket without micro osteoperforation

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Alazhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Both male and female patients between the age (14-20 y).
• Patients indicated for maxillary first premolar extraction.
• Angle's Class I bimaxillary, Class II Division 1 malocclusion (ANB <5).
• Irregularity index < 4 mm.
• No previous orthodontic treatment.
• Fully erupted dentition.

Exclusion Criteria:

• Patients not indicated for non-extraction approach.
• Prominent canine root (in labial cortical bone).
• History of systemic and medical illness that could interfere with OTM.
• Previous orthodontic treatment.
• Extreme skeletal class II occlusion (ANB >5).
• Poor oral hygiene or periodontally compromised patient

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1; Patient with self-ligating bracket system split mouth with and without micro-osteoperforations. Extraction of first premolars were done. A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment.	Biological: self ligating bracket with micro osteoperforation; A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment. Micro-osteoperforations will be formed; Biological: self ligating bracket without micro osteoperforation; A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment.
Active Comparator: group 2; Patient with conventional bracket with split mouth with and without micro-osteoperforations. Extraction of first premolars were done. A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment.	Biological: conventional bracket with micro osteoperforation; A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel-titanium were followed to achieve leveling and alignment. Micro-osteoperforations will be formed.; Biological: conventional bracket without micro osteoperforation; A standardized wire sequence of .012'', 0.014'',0,016'', and 0.016''×0.022'' nickel titanium were followed to achieve leveling and alignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of canine retraction	assessment of maxillary canine retraction rate using self-ligating brackets system assisted with micro-osteoperforations.	at 6 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: khaled sobhy abdelaziz, master, Al-Azhar University

Publications and helpful links

General Publications

• Abbing A, Koretsi V, Eliades T, Papageorgiou SN. Duration of orthodontic treatment with fixed appliances in adolescents and adults: a systematic review with meta-analysis. Prog Orthod. 2020 Oct 5;21(1):37. doi: 10.1186/s40510-020-00334-4.

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2024
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: October 23, 2022
• First Submitted That Met QC Criteria: October 23, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 850/2057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No