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

Alexandria University

Status: Not yet enrolling

Conditions: Orthodontic Aligners; Bone Metabolism

Treatments: Other: Directly printed aligners using Tera Harz TA28 resin; Other: PETG thermoplastic sheets

Study type: Interventional

Funder types: Other

Identifiers

NCT07617571

1070-05/2025

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

directly printed aligners

Experimental group

Treatment:

Other: Directly printed aligners using Tera Harz TA28 resin

thermoformed aligners

Active Comparator group

Treatment:

Other: PETG thermoplastic sheets