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CAD/CAM nitinol bonded retainer versus a chairside bonded retainer: a multicentre randomised controlled trial

CAD/CAM nitinol bonded retainer versus a chairside bonded retainer: a multicentre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17122529
Enrollment
100
Registered
2018-02-12
Start date
2017-10-20
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Orthodontic relapse Oral Health

Interventions

Simple randomisation will be used to allocate patients to one of the two groups. The randomisation website: www.sealedenvelope.com will be used to allocate patients to treatment group 1 or group 2. Bl

Sponsors

Leeds Dental Institute
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Each subject will: 1. Have undergone a course of upper and lower fixed appliance orthodontic treatment with satisfactory correction of the presenting malocclusion, where the treating clinician feels that retention is required 2. Have a full and normal complement of teeth in the upper and lower labial segments (incisors and canines) with these teeth being of normal size and shape 3. Brush their teeth at least twice per day 4. Be in good health 5. Be willing and able to comply with the trial regime 6. Have given written informed consent Subjects may: 1. Have received treatment at any of the research sites 2. Have had dental extractions (premolar or molar) or a non-extraction approach 3. Have had other orthodontic treatment (e.g. removable or functional appliances) as part of their orthodontic treatment 4. Have undergone adjunctive surgical treatment, whether minor oral surgery to expose a tooth or orthognathic surgery to correct the position of the jaws

Exclusion criteria

Exclusion criteria: Subjects with: 1. Nickel allergy 2. Cleft palate and/or other severe facial deformity 3. Poor periodontal health including the presence of supragingival or subgingival calculus or periodontal pocketing greater than 3.5mm as determined by a basic periodontal examination (BPE) probe 4. Gross or uncontrolled caries 5. Prosthodontic requirement in the upper or lower arch at end of treatment 6. Restorations on the palatal/lingual surfaces of upper or lower incisors or canines 7. A starting malocclusion requiring extreme transverse correction

Design outcomes

Secondary

MeasureTime frame
Assessed at the 6 week, 6 month, 1 year, 2 year and 5 year review appointments: 1. The survival rate of each retainer type 2. The patient satisfaction with each retainer type Assessed at the 1 year and 5 year review appointments: 1. The cost-effectiveness of each retainer type

Primary

MeasureTime frame
Stability measured by changes in Little's Irregularity Index, and the width of the upper and lower dental arches measured by inter-canine and inter-molar width. In extraction cases, the trialists will also assess whether or not the extraction space re-opens. These measurements will be carried out on orthodontic study models taken at the debond appointment, and the 6 month, 1 year, 2 year and 5 year review appointments.

Countries

England, United Kingdom

Outcome results

None listed

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