Bone Metabolism, Orthodontic Aligners
Conditions
Brief summary
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.
Interventions
OTHERDirectly 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.
OTHERPETG 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.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patients will be blinded at appliance delivery, to reduce the risk of bias. Moreover, the biologist in the laboratory who will do the measurements, and the statistician will be blinded to the nature of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in levels of Osteoprotegerin (OPG) | 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
| Measure | Time frame | Description |
|---|---|---|
| change in gingival inflammation | 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) |
| change in plaque accumulation | 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) |
| change in bleeding on probing | 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 |
Countries
Egypt
Contacts
CONTACTAhmed Karkoura, BDS
Outcome results
None listed