Alveolar Bone Loss, Dental Crowding, Malocclusion
Conditions
Keywords
clear aligners, fixed orthodontic appliances, alveolar bone level, alveolar bone thickness, cone-beam computed tomography, incisor inclination, torque, Little's Irregularity Index, rate of alignment, non-extraction treatment, adults
Brief summary
This study compares two common ways of straightening teeth in adults who have mild-to-moderate crowding of the lower front teeth and do not need any teeth removed: clear aligners and traditional fixed braces. The main aim is to find out whether the two methods differ in how they affect the bone that surrounds the teeth. Using three-dimensional X-ray scans (cone-beam CT) and digital models of the teeth taken before and during treatment, the researchers measure the level and thickness of the bone around the lower front teeth, the tilt (inclination) of the lower front teeth, and how quickly the crowding is corrected. Adults are randomly assigned to receive either clear aligners or fixed braces, and the same measurements are compared between the two groups over about six months.
Interventions
Brackets bonded first-molar-to-first-molar; alignment sequence 0.014" NiTi → 0.016" NiTi → 0.016 × 0.022" NiTi → 0.017 × 0.025" stainless steel. Interproximal reduction performed on assigned contacts where indicated.
DEVICEClear aligners
Digital intraoral scan and staging (3Shape Ortho Analyzer); 3D-printed models thermoformed into aligners; attachments bonded where planned; sequential aligners worn \~22 h/day. Interproximal reduction per contact from canine-to-canine is done.
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and care providers cannot be masked because the two appliances are visibly different. All CBCT and digital-model measurements are performed by independent outcome assessors blinded to group allocation, and the statistician analyses coded data.
Intervention model description
Two arms in parallel; participants are assigned 1:1 to clear aligners or fixed appliances for the full \ 6-month levelling and alignment phase.
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Adults 18-25 years of age, of both sexes. * Mild-to-moderate mandibular anterior crowding (2-6 mm). * Angle Class I molar relationship with normal overjet (1-3 mm) and overbite (1-2 mm). * Full permanent dentition with a healthy periodontium. * Normal anteroposterior and vertical skeletal pattern.
Exclusion criteria
* Any local or systemic condition, or trauma, capable of affecting craniofacial growth and development. * History of previous orthodontic or interceptive treatment. * Loss of periodontal attachment. * Craniofacial anomalies, facial asymmetry or skeletal discrepancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in alveolar bone level | Baseline (T0) and end of alignment phase (T3)) (approximately 6 months) | Change (mm) in the distance from the cemento-enamel junction to the alveolar crest on the labial and lingual aspects of the mandibular central incisors, lateral incisors and canines, measured on CBCT (OnDemand software), calculated as the difference between baseline and end-of-alignment values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in alveolar bone thickness | Baseline (T0) and end of alignment phase (≈ 6 months) | Change (mm) in labial and lingual alveolar bone thickness measured at 3 mm and 6 mm from the CEJ and at the root apex of the mandibular central incisors, lateral incisors and canines on CBCT (OnDemand software), from baseline to end of alignment. |
| Change in mandibular incisor inclination (torque) | Baseline (T0) and end of alignment phase (≈ 6 months) | Change (degrees) in the inner angle between the long axis of each mandibular central incisors, lateral incisors and canines and the mandibular plane, measured on the sagittal view of CBCT (Invivo/Anatomage software), from baseline to end of alignment. |
| Rate of alignment (Little's Irregularity Index) | Baseline (T0), 8 weeks (T1), 16 weeks (T2) and end of alignment (T3, ≈ 24 weeks / 6 months) | Reduction in mandibular anterior crowding quantified by Little's Irregularity Index (mm) - the sum of the displaced anatomic contact points from canine to canine - measured on serial digital models; the change across time points and the percentage improvement from baseline describe the rate of alignment. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORahmed mohamed hesham elzoghary
Faculty of Oral and Dental Medicine, Future University in Egypt
Outcome results
None listed