NCT07350343

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
13mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Feb 2026Jun 2027

First Submitted

Initial submission to the registry

January 5, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

January 5, 2026

Last Update Submit

April 11, 2026

Conditions

Class I MalocclusionRotationCrowded TeethSpacing of Anterior Teeth

Keywords

direct printed graphy... thermoform

Outcome Measures

Primary Outcomes (1)

  • predictability of tooth movement

    The primary outcome will be calculated as the percentage difference between the final and initial positions for each individual tooth movement assessed and will be expressed as a continuous numerical variable representing tooth movement predictability (%).

    12 months

Secondary Outcomes (4)

  • predictability within different types

    12 months

  • Colour change of clear aligners

    12 months

  • Degree of Conversion

    12 months

  • shape memory effect

    12 months

Study Arms (2)

Direct-printed aligner (Graphy)

EXPERIMENTAL

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

Device: Direct-printed aligner (Graphy)

Thermoformed aligner

ACTIVE COMPARATOR

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

Device: Thermoformed aligner

Interventions

Direct-printed aligner (Graphy)DEVICE

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.

Direct-printed aligner (Graphy)
Thermoformed alignerDEVICE

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.

Thermoformed aligner

Eligibility Criteria

Age16 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The sample will be recruited from multicentre clinics (Private dental clinic, Orthodontic Department at Karbala Governmental Specialized Dental Centre, Orthodontic Department, College of Dentistry University of Baghdad).

Karbala, Iraq

Location

MeSH Terms

Conditions

Malocclusion, Angle Class ICrowding

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic DiseasesSpatial BehaviorBehavior

Study Officials

  • hussin anwar

    University of Baghdad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist.. PhD student

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 20, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

IR(1)