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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Metabolism; Orthodontic Aligners
• Intervention / Treatment: Other: Directly printed aligners using Tera Harz TA28 resin; Other: PETG thermoplastic sheets

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Karkoura, BDS; Phone Number: 002 01110309060; Email: ahmed.abdalrahman.dent@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Faculty of Dentistry, Alexandria University
    • Contact: Ahmed Karkoura, BDS
    • Principal Investigator: Ahmed Karkoura, BDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: directly printed aligners	Other: Directly printed aligners using Tera Harz TA28 resin; 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.
Active Comparator: thermoformed aligners	Other: PETG thermoplastic sheets; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in gingival inflammation	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)	up to 21 days
change in plaque accumulation	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)	up to 21 days
change in bleeding on probing	A clinical sign of gingival inflammation detected when gentle probing of the gingival sulcus causes bleeding. it is yes/no variable	up to 21 days

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: May 24, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1070-05/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No