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

N/ANot Yet RecruitingNCT07617571

Alexandria University30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bone Metabolism Orthodontic Aligners

Interventions

Directly printed aligners using Tera Harz TA28 resinOTHER

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 sheetsOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 25 Years

Medical Language ↔ Plain English

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.

Locations (1)

Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

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).

Time frame: up to 21 days

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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

Time frame: up to 21 days

Central Contacts

Ahmed Karkoura, BDS

CONTACT

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

Data from ClinicalTrials.gov

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