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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06410105
Other study ID # Tishreen U _orthodontic
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 19, 2020
Est. completion date March 15, 2024

Study information

Verified date December 2020
Source Tishreen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date March 15, 2024
Est. primary completion date November 20, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Syrian Arab Republic Tishreen University Latakia

Sponsors (1)

Lead Sponsor Collaborator
Tishreen University

Country where clinical trial is conducted

Syrian Arab Republic, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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Completed NCT02745626 - Comparison of Oral Hygiene & Root Resorption During Orthodontic Treatment N/A
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