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NCT Number: NCT07617571

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

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.

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Key information

Conditions

Bone Metabolism Orthodontic Aligners

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location contact

Ahmed Karkoura, BDS

CONTACT

Ahmed Karkoura, BDS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. change in levels of Osteoprotegerin (OPG)

    Time frame: up to 21 days

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

Secondary outcomes

  1. change in gingival inflammation

    Time frame: up to 21 days

    A measure used to assess the severity of gingival inflammation based on color, consistency, and bleeding of the gingiva. Scores range from healthy gingiva (score 0) to severe inflammation (Score 3)

  2. change in plaque accumulation

    Time frame: up to 21 days

    A clinical index used to assess the amount of dental plaque accumulated on tooth surfaces. It helps evaluate oral hygiene status by scoring plaque from (score 0) no plaque to heavy plaque accumulation (score 3)

  3. change in bleeding on probing

    Time frame: up to 21 days

    A clinical sign of gingival inflammation detected when gentle probing of the gingival sulcus causes bleeding. it is yes/no variable

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Karkoura, BDS

CONTACT

[email protected]

01110309060 ext. 002

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Bone Metabolism in Patients Treated With 3d Printed Aligners Versus Thermoformed Aligners (Randomized Controlled Clinical Trial)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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