The Predictability of Directly Printed Versus Thermoformed Clear Aligners

University of Baghdad

Status: Not yet enrolling

Conditions: Crowded Teeth; Rotation; Class I Malocclusion; Spacing of Anterior Teeth

Treatments: Device: Thermoformed aligner; Device: Direct-printed aligner (Graphy)

Study type: Interventional

Funder types: Other

Identifiers

NCT07350343

1154425

Details and patient eligibility

About

The study is randomized controlled trial ...The null hypothesis suggests that there is no significant difference between actual and predicted dental movement in patients treated using direct printed aligners produced with Graphy™ Tera Harz TA-28 resin as compared to those treated with thermoformed clear aligner therapy.

Full description

the patients will be randomly assigned to one of two study groups which either direct printed or thermoformed clear aligner. All patients would be given the same instructions: aligners had to be worn for at least 22 hours per day, except during meals and oral hygiene activities, and should be changed every 10 days.Teeth positions would be planned according to esthetic and functional principles, starting with the 3D T0 digital model and aligning and leveling dental arches following orthodontic aligner biomechanical principles. Each aligner had a planned movement speed of 0.2 mm linear displacement, 2° long-axis rotation, and a vestibulo-lingual inclination of 2.5°.

Enrollment: 36 estimated patients

Sex: All

Ages: 16 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with mild to moderate malocclusion that can be treated by less than 40 steps of aligner treatment, including those with dental rotation of < 30°, diastema or crowding of < 8 mm.
• Patients aged ≥ 16 years with fully erupted permanent teeth (regardless of the third molar).
• No supernumerary teeth, no enamel malformation.
• No tooth shape anomalies

Exclusion criteria

• Systemic pathologies such as uncontrolled diabetes or heart diseases
• active or past periodontal disease
• previous orthodontic treatment
• temporomandibular joint disorders
• ongoing pharmacological treatment could influence orthodontic treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Direct-printed aligner (Graphy)

Experimental group

Description:

Patients will be treated with direct-printed Graphy aligners until dental levelling alignment; space closure is finished.

Treatment:

Device: Direct-printed aligner (Graphy)

Thermoformed aligner

Active Comparator group

Description:

Patients will be treated with thermoformed aligners until dental alignment, levelling, space closure is finished.

Treatment:

Device: Thermoformed aligner