Menu
Enrolling by invitation NCT07350343

The Predictability of Directly Printed Versus Thermoformed Clear Aligners

No phase Interventional Class I Malocclusion Crowded Teeth Spacing of Anterior Teeth Rotation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Direct-printed aligner (Graphy), Thermoformed aligner.
Who it may be relevant to
Registry conditions: Class I Malocclusion, Crowded Teeth, Spacing of Anterior Teeth, Rotation. Basic parameters: 16 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iraq
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Predictability of Directly Printed Shape Memory (Graphy) Versus Thermoformed Clear Aligners: A Randomized Clinical Trial

Overview

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 aligners.

Detailed 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°.

Interventions

  • Device Direct-printed aligner (Graphy)
    intraoral scanner would be used to scan patient teeth then aligner fabrication by direct printing then the patient will be treated with direct-printed aligners(graphy) until dental levelling alignment; space closure is finished. 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.
  • Device Thermoformed aligner
    An intraoral scanner would be used to scan patient teeth then aligner fabrication by thermoforming then the Patients will be treated with thermoformed aligners until dental alignment, levelling, space closure is finished. 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.

Primary outcome measures

  • predictability of tooth movement [Time frame: 12 months]
Secondary outcome measures (4)
  • predictability within different types [Time frame: 12 months]
  • Colour change of clear aligners [Time frame: 12 months]
  • Degree of Conversion [Time frame: 12 months]
  • shape memory effect [Time frame: 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Iraq · 1 center
  • The sample will be recruited from multicentre clinics (Private dental clinic, Orthodontic — Karbala

Identifiers

NCT: NCT07350343 · 1154425

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗