A comparison of mandibular archwidth changes using two different bracket systems

A comparison of mandibular archwidth changes using two different bracket systems: a randomised controlled clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68289972

Enrollment

Registered

2012-01-03

Start date

2011-12-01

Completion date

Unknown

Last updated

2018-03-26

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

Conditions

Orthodontics ? mandibular archform Oral Health

Interventions

Patients will be randomised into one of the two arms of study. Each arm of study will use a different bracket system, either: 1. Self-ligating brackets (Damon Q) 2. Non self-ligating brackets Treatme

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients: 1. Aged between 11 and 21 years of age 2. In the permanent dentition 3. Requiring upper and lower fixed appliances 4. Receiving treatment in the lower arch on a non-extraction basis 5. With mild lower arch crowding 6. All malocclusions

Exclusion criteria

Exclusion criteria: 1. Impacted teeth in the lower arch 2. Hypodontia in the lower arch 3. Extractions in the lower arch

Design outcomes

Primary

Measure	Time frame
Mandibular archwidth changes 1. Alginate impressions for study models of the maxillary and mandibular arches will be taken at: T0: Before placement of fixed appliances, at the start of treatment. T1: Removal of 0.014 inch round NiTi archwire and placement of 0.014 x 0.025 inch NiTi archwire T2: Removal of 0.014 x 0.025 inch NiTi archwire and placement of 0.018 x 0.025 inch NiTi archwire T3: Removal of 0.018 x 0.025 inch NiTi archwire and placement of next archwire These study models will be used to measure mandibular archwidth between the 2 groups at T0, T1, T2, and T3 measured at 4 places across arch (c-c, p1-p1, p2-p2, m-m). 2. Arch width measurements (from study models) c-c: Intercanine width: distance between the mandibular canine tips or between the central fossae on the surfaces in case of worn cusps p1-p1: First inter premolar width: distance between the central fossae on the occlusal surfaces of the maxillary first premolars p2-p2: Second inter premolar width: distance between the central fossae on occlusal surfaces of the maxillary second premolars m-m: Intermolar width: distance between the mesial ends of the central fissures on the occlusal surfaces of the maxillary first molars Measurement for the inter arch distances will be measured in mm using fine-pointed digital callipers. The measurements will be approximated to the first decimal place. All measurements will be carried out by a single investigator to avoid inter-operator error. Intra-operator reliability will be assessed by repeating measurements on 10 study casts 2 weeks apart and carrying out an error analysis.	—

Measure

Time frame

Mandibular archwidth changes 1. Alginate impressions for study models of the maxillary and mandibular arches will be taken at: T0: Before placement of fixed appliances, at the start of treatment. T1: Removal of 0.014 inch round NiTi archwire and placement of 0.014 x 0.025 inch NiTi archwire T2: Removal of 0.014 x 0.025 inch NiTi archwire and placement of 0.018 x 0.025 inch NiTi archwire T3: Removal of 0.018 x 0.025 inch NiTi archwire and placement of next archwire These study models will be used to measure mandibular archwidth between the 2 groups at T0, T1, T2, and T3 measured at 4 places across arch (c-c, p1-p1, p2-p2, m-m). 2. Arch width measurements (from study models) c-c: Intercanine width: distance between the mandibular canine tips or between the central fossae on the surfaces in case of worn cusps p1-p1: First inter premolar width: distance between the central fossae on the occlusal surfaces of the maxillary first premolars p2-p2: Second inter premolar width: distance between the central fossae on occlusal surfaces of the maxillary second premolars m-m: Intermolar width: distance between the mesial ends of the central fissures on the occlusal surfaces of the maxillary first molars Measurement for the inter arch distances will be measured in mm using fine-pointed digital callipers. The measurements will be approximated to the first decimal place. All measurements will be carried out by a single investigator to avoid inter-operator error. Intra-operator reliability will be assessed by repeating measurements on 10 study casts 2 weeks apart and carrying out an error analysis.

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Secondary

Measure	Time frame
1. Pain perception will be recorded using a pain questionnaire, to be completed by patients following each archwire change at: 1.1. 2 hrs 1.2. 6 hrs 1.3. Bedtime on day of appointment 1.4. When they wake up the day after their appointment 1.5. When they wake up 2 days after their appointment 1.6. When they wake up 3 days after their appointment 2. Anxiety experienced will be recorded using an anxiety questionnaire, to be completed by participant at end of appointment 3. Any appliance breakages during treatment will be recorded	—

Measure

Time frame

1. Pain perception will be recorded using a pain questionnaire, to be completed by patients following each archwire change at: 1.1. 2 hrs 1.2. 6 hrs 1.3. Bedtime on day of appointment 1.4. When they wake up the day after their appointment 1.5. When they wake up 2 days after their appointment 1.6. When they wake up 3 days after their appointment 2. Anxiety experienced will be recorded using an anxiety questionnaire, to be completed by participant at end of appointment 3. Any appliance breakages during treatment will be recorded

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Countries

United Kingdom

Outcome results

None listed

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