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Esthetic orthodontic appliance (bracketless orthodontic technique)

Effectiveness of bracketless fixed orthodontic technique (coated e-wires) for treatment of mild crowding cases in adults: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN93371079
Enrollment
48
Registered
2025-05-20
Start date
2024-10-03
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic tooth movement Oral Health

Interventions

Patients will be randomly assigned in a 1:1 allocation ratio to the two groups: 1. Experimental group: patients treated with the bracketless orthodontic technique (BOT) 2. Control group: patients trea

Sponsors

Damascus University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 28 years 2. Complete dentition except for third molars 3. Mild dental crowding ranging from 1 to 4 mm, not requiring the extraction of any teeth 4. Class I molar and canine relationship according to Angle’s classification 5. Skeletal sagittal relationship Class I (1 < ANB < 4), with normal growth pattern according to Björk (396 ± 6) 6. Lower incisor axis angle with the mandibular plane not exceeding 95°, and upper incisor axis angle with the anterior cranial base not exceeding 107° 7. Patients have good oral health: Plaque Index =1

Exclusion criteria

Exclusion criteria: 1. Patients with systemic health conditions affecting tooth movement 2. Teeth with deep caries or extensive restorations 3. Patients with impacted teeth 4. Patients who have undergone previous orthodontic treatment 5. Smokers

Design outcomes

Primary

MeasureTime frame
1. Time required for alignment of mildly crowded upper and lower teeth, measured in days, from the date of appliance placement to the point at which the Little’s Irregularity Index reaches zero. 2. Little’s Irregularity Index values accompanying the alignment of mildly crowded upper and lower teeth. The percentage of alignment will be determined using the following formula: [(Little’s Index at T0 – Little’s Index at the specified timepoint) / Little’s Index at T0] × 100 Dental impressions will be taken and casts poured monthly at each archwire change, starting from the beginning of treatment until alignment and leveling are complete, as follows: T0: before the start of treatment T1: 1 month after the start of treatment T2: 2 months after the start of treatment T3: 3 months after the start of treatment T4: 4 months after the start of treatment Tf: the final impression taken when Little’s Irregularity Index equals zero 3. Overjet, overbite, and arch length and width resulting from the alignment of mildly crowded upper and lower teeth: 3.1. The overjet will be measured at two timepoints: before the start of treatment (T0) and after the alignment of the anterior teeth is complete (Tf). The value at T0 will then be subtracted from the value at Tf to determine the change. 3.2. The overbite will be measured at two timepoints: before the start of treatment (T0) and after the alignment of the anterior teeth is complete (Tf). The value at T0 will then be subtracted from the value at Tf to determine the change. 3.3. Anterior dental arch length = SLux100/160 3.4. Lower dental arch length = Lu-2mm 4. Axial inclinations of upper and lower incisors resulting from the alignment of mildly crowded upper and lower teeth. To calculate the amount of change in the position of the lower incisor axes, the angle formed between the axis of the lower incisor (L1) and the mandibular plane (ML) will be measured at both timepoints (before starting treatment [T0] and after completing the alignm

Secondary

MeasureTime frame
1. Pain and discomfort assessed using a Visual Analogue Scale (VAS) daily for 5 days following the application of any new orthodontic wire 2. Oral health-related quality of life (OHRQoL) measured using the Oral Health Impact Profile (OHIP) questionnaire at five different timepoints: T0: Before the start of treatment T1: 1 month after treatment initiation T2: 2 months after treatment initiation T3: 3 months after treatment initiation T4: At the end of treatment 3. Periodontal indices: Plaque Index (PI), Gingival Index (GI), Papillary Bleeding Index (PBI); clinically assessed at the following timepoints: T0: Before starting treatment T1: 1 month after treatment initiation T2: 2 months after treatment initiation T3: At the end of treatment

Countries

Syria

Contacts

Public ContactNataly Alqaisi
nataly.qaisi@gmail.com+963 (0)947688800

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026