Bone Metabolism in Patients Treated With 3d Printed Aligners Versus Thermoformed Aligners

NCT07617571 | Not Yet Recruiting

• 1 other identifier: 1070-05/2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Orthodontic forces induce tissue reactions by triggering perturbations from orthodontic appliances, which lead to the modelling and remodelling of alveolar bone. Despite the growing popularity of 3D-printed aligners, no studies have compared their effects on bone metabolism in comparison with thermoformed aligners. Aim: This study aims to assess bone metabolism in patients undergoing treatment with 3D-printed aligners versus thermoformed aligners.

Conditions

Bone Metabolism; Orthodontic Aligners

Outcome Measures

Primary Outcomes (1)

• change in levels of Osteoprotegerin (OPG)

  The frozen samples of GCF from participants with both types of aligners will be thawed at room temperature for enzyme-linked immunosorbent assay (ELISA).

  up to 21 days

Secondary Outcomes (3)

• change in gingival inflammation

  up to 21 days

• change in plaque accumulation

  up to 21 days

• change in bleeding on probing

  up to 21 days

Study Arms (2)

directly printed aligners

EXPERIMENTAL

Other: Directly printed aligners using Tera Harz TA28 resin

thermoformed aligners

ACTIVE COMPARATOR

Other: PETG thermoplastic sheets

Interventions

Directly printed aligners using Tera Harz TA28 resin OTHER

Aligners will be digitally designed using the latest version of ArchForm software for segmentation of dental arches, virtual tooth movement planning and generation of sequential treatment stages, the finalized setups will be exported as STL files.

directly printed aligners

PETG thermoplastic sheets OTHER

Aligners were digitally designed using the latest version of ArchForm software .The 3D-printed resin models which were used as a mold for aligner thermoforming, were fabricated by Anycubic Photon Mono M5s (12K resolution) (Anycubic, China) 3D printing machine.

thermoformed aligners

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Minor malocclusion (2 to 4 mm of crowding) .
• Patients in need for Antero-posterior expansion and labial tipping of incisors without interproximal reduction
• No use of anti-inflammatory drugs or antibiotics in the past 6 months.
• Periodontal parameters of gingival index \<1 and no pocketing with a generalized pocketing depth of \<3mm.
• Radiographic parameters of no crestal bone loss.
• No history of smoking.

You may not qualify if:

• Signs of inflammation of the gingiva, and periodontitis.
• Systemic conditions (kidney disease, HIV, and liver disease).
• Teeth missing or poor oral hygiene.
• Bone disease e.g.; osteoporosis.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

Central Study Contacts

Ahmed Karkoura, BDS

CONTACT

01110309060; ahmed.abdalrahman.dent@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients will be blinded at appliance delivery, to reduce the risk of bias. Moreover, the biologist in the laboratory who will do the measurements, and the statistician will be blinded to the nature of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: July 1, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

EG (1)