NCT06410105

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 19, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
Last Updated

May 10, 2024

Status Verified

December 1, 2020

Enrollment Period

2.9 years

First QC Date

May 4, 2024

Last Update Submit

May 8, 2024

Conditions

Keywords

Orthodontic, clear aligners, fixed appliances, CBCT

Outcome Measures

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.)

    two years

Secondary Outcomes (1)

  • comparative study of Buccolingual Inclination changes

    two years

Study Arms (2)

Groub(1): 13 patient treated with CLEAR ALIGNERS

EXPERIMENTAL

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

Groub(2): 13 patient treated with a fixed orthodontic

EXPERIMENTAL

. 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

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

Groub(1): 13 patient treated with CLEAR ALIGNERSGroub(2): 13 patient treated with a fixed orthodontic

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tishreen University

Latakia, Syria

Location

Study Officials

  • fadi khalil, prof

    Tishreen University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: : Crossover Assignment A randomized, controlled, crossover, double-blind clinical study, Comparison of
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2024

First Posted

May 10, 2024

Study Start

December 19, 2020

Primary Completion

November 20, 2023

Study Completion

March 15, 2024

Last Updated

May 10, 2024

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

study protocol ,Informed Consent From

Shared Documents
ICF
Time Frame
9 month

Locations