The Efficiency of Clear Aligners in Maxillary Molar Distalization: A Randomized Clinical Trial. (Aligner)

The Accuracy of Clear Aligners in Maxillary Molar Distalization With and Without Attachments: A Randomized Clinical Trial.

The aim of this study is to evaluate the accuracy of clear aligners on the amount of the maxillary molar distalization.

Study Overview

• Status: Recruiting
• Conditions: Orthodontic Aligners
• Intervention / Treatment: Device: Molar distalization by aligners with attachment

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Ibrahim Atalla, PhD; Phone Number: +201096290800; Email: ahmed.atalla@dentistry.cu.edu.eg
• Study Contact Backup: Name: Noha E Sabet, Prof; Phone Number: 01001942079

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • AinShams University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age more than15 years.
2. Gender; male or female.
3. Skeletal Class I or Class II malocclusion and a bilateral half-cusp class II molar relationship that require molar distalization.
4. Mild crowding in the upper arch (≤ 4 mm).
5. Absence or previous extraction of the upper third molars.
6. Good compliance during the treatment

Exclusion Criteria:

1. Transversal dental or skeletal discrepancies.
2. Extraction treatment (except for the third molar).
3. Periodontal disease. .
4. Prosthodontics rehabilitation of the maxillary molars.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Molar distalization by aligners without attachment	Device: Molar distalization by aligners with attachment; Plaster dental models will be poured from the rubber base impression.; Digital dental models will be created through scanning of plaster dental models.; Planning of the aligners will be done on 3 shape clear aligner.; Aligners will be fabricated on 3d printed models.; Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks.; Patient will receive the following aligner after 2 weeks.; Follow up visits every 4weeks until 6 months.
Experimental: Molar distalization by aligners with attachments	Device: Molar distalization by aligners with attachment; Plaster dental models will be poured from the rubber base impression.; Digital dental models will be created through scanning of plaster dental models.; Planning of the aligners will be done on 3 shape clear aligner.; Aligners will be fabricated on 3d printed models.; Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks.; Patient will receive the following aligner after 2 weeks.; Follow up visits every 4weeks until 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficiency of aligners in molar distalization	T2(3shape)-T1(actual) <mm>	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of anchorage loss	Linear ( mm)	6 months
Amount of molar tipping	Angular	6 months

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Noha E Sabet, Prof, AIN shams university; Study Director: Marwa s Abdelatef, Phd, AIN shams university

Study record dates

Study Major Dates

• Study Start (Estimated): April 27, 2024
• Primary Completion (Estimated): January 15, 2025
• Study Completion (Estimated): July 15, 2025

Study Registration Dates

• First Submitted: March 17, 2022
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Orthodontic, aligner, molar
• Other Study ID Numbers: Aligners in distalization

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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