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CompletedNCT06410105Updated May 10, 2024

Orthodontic Treatment With Clear Aligner

An interventional study of CLEAR ALIGNERS in Orthodontic Pathological Resorption of External Root, sponsored by Tishreen University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-10.

Sponsored by Tishreen University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 4 months after the study started (first participant enrolled Dec 2020, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Orthodontic Pathological Resorption of External Root

Keywords

  • Orthodontic, clear aligners, fixed appliances, CBCT
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In context

Lead sponsor

Tishreen University is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
26 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DeviceCLEAR 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

06

What researchers measure

Primary outcomes

  1. 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.)

    Time frame: two years

Secondary outcomes

  1. 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.

    Time frame: two years

07

Study locations

1 site
  • Tishreen University
    Latakia, Syrian Arab Republic
08

References and documents

Individual participant data

Plan to share: Yes — study protocol ,Informed Consent From

Supporting information: Informed consent form

Time frame: 9 month

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06410105
Lead sponsor
Tishreen University
Responsible party
Sponsor
First posted
May 10, 2024
Start date
Dec 19, 2020
Primary completion
Nov 20, 2023
Completion
Mar 15, 2024
Last update
May 10, 2024

Study contacts

fadi khalil, prof
study chair · Tishreen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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