Orthodontic Treatment With Clear Aligner

Three-dimensional Assessment of Root Resorption Following Treatment With Clear Aligners Using Cone Beam Computed Tomography

Three-dimensional Assessment of Root Resorption following treatment with clear aligners using Cone Beam Computed Tomography Design: A randomized, controlled, crossover, double-blind clinical study including twenty six adult , aged 18-25 years old.

Study Overview

• Status: Completed
• Conditions: Orthodontic Pathological Resorption of External Root
• Intervention / Treatment: Device: CLEAR ALIGNERS

Detailed Description

Orthodontically induced root resorption is one of the common undesirable sequalae of orthodontic treatment. one third of the patients treated with fixed appliances showed more than 3 mm of root resorption whereas at least 2% of orthodontic patients showed more than 5 mm of root resorption.

There is a controversy in the literature regarding the effect of clear aligners on apical root resorption. One previous study reported that some kinds of removable aligners may have the potential of minimizing orthodontic ally induced root resorption due to the studied piezoelectric property by these materials Till now, the degree of apical root resorption following treatment with (in house) aligners has not been reported in the literature.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Syrian Arab Republic
  • Latakia, Syrian Arab Republic
    • Tishreen University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

The Clinical Diagnosis the age of patients ranges between 18-25 years, medium crowding between 3-6 mm in the area of the upper anterior teeth according to Little irregularity index 20,class1 according angel classification healthy patient No previous orthodontic treatment vital teeth with periodontal tissue without root absorption,

Exclusion Criteria:

Previous history of orthodontic or orthopedic treatment. Presence of craniofacial anomalies. Presence of any signs and symptoms of gingival and periodontal diseases. Presence of significant medical history (including drug allergy). Pregnant and lactating women

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Groub(1): 13 patient treated with CLEAR ALIGNERS; The CA group included 13 patients treated with clear aligners Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm	Device: CLEAR ALIGNERS; The CA group included 13 patients treated with clear aligners Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm
Experimental: Groub(2): 13 patient treated with a fixed orthodontic; . The FA group included 13 patients treated with a fxed orthodontic appliance (american orthodontics, WI.Sheboygam, USA). Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm, which	Device: CLEAR ALIGNERS; The CA group included 13 patients treated with clear aligners Tree-dimensional images were captured using a CBCT scan (KaVo® Dental GmbH, Bismarckring, Germany). Te pre-treatment imaging parameters were 120 kV, 5 mA, 0.3 mm voxel size, and a feld of view of 230×170 mm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment with clear aligners	to determine the root resorption for upper anterior teeth following treatment with clear aligners orthodontic appliances CA comparison with fixed appliances using CBCT.)	two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparative study of Buccolingual Inclination changes	to evaluate the Buccolingual Inclination changes and for upper anterior teeth following treatment with clear aligners orthodontic appliances CA comparison with fixed appliances using CBCT.	two years

Collaborators and Investigators

• Sponsor: Tishreen University
• Investigators: Study Chair: fadi khalil, prof, Tishreen University

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2020
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: May 4, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Orthodontic, clear aligners, fixed appliances, CBCT
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Resorption
• Other Study ID Numbers: Tishreen U _orthodontic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: study protocol ,Informed Consent From
• IPD Sharing Time Frame: 9 month
• IPD Sharing Supporting Information Type: ICF

Drug and device information, study documents

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