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A prospective randomized trial investigating lower incisor inclination and mandibular arch dimensional changes of two pre-adjusted edgewise orthodontic bracket systems in non-extraction cases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67900267
Enrollment
20
Registered
2007-09-28
Start date
2006-09-22
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Oral Health: Orthodontics Oral Health Orthodontics

Interventions

Smart-Clip® ligature free brackets vs conventional pre-adjusted edgewise brackets (3M Unitek).

Sponsors

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients should be fit and well and not currently on any medication or suffering from any craniofacial syndrome. Medication could theoretically affect the connective tissues that remodel during orthodontic treatment 2. Children under 18 years 3. Lower incisor tooth crowding of up to 5mm as part of their malocclusion 4. A requirement for fixed orthodontic treatment on a non-extraction basis 5. More severely crowded dentitions often require the loss of premolar teeth to provide the necessary space for alignment of the dental arch

Exclusion criteria

Exclusion criteria: 1. A complete overbite. Complete overbite might be expected to reduce rates of tooth alignment due to bracket interferences. 2. No incisor teeth completely excluded from the dental arch

Design outcomes

Primary

MeasureTime frame
The ability of two fixed appliance orthodontic bracket systems to align crowded lower incisors. In particular lower incisor inclination and arch form changes will be compared. Null hypothesis: there is no difference in lower incisor inclination, and angulation, and lower arch dimensions using self-ligating and conventional pre-adjusted edgewise brackets.

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

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