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

ConditionsBone MetabolismOrthodontic Aligners
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-25
SponsorAlexandria University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Directly printed aligners using Tera Harz TA28 resin

    Other intervention

    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 intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: directly printed alignersExperimental treatment 1 intervention
Group B: thermoformed alignersActive comparator 1 intervention

Trial outcomes

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).

Time frame
up to 21 days

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: