None listed
Conditions
Brief summary
This randomised controlled trial aims to compare the effectiveness of three types of fixed orthodontic retainers in maintaining lower front tooth alignment after orthodontic treatment. Participants will receive either a CAD/CAM 0.026-inch stainless steel retainer, a CAD/CAM 0.018-inch stainless steel retainer, or a conventional multi-stranded stainless steel retainer. All participants will also receive a standard lower removable vacuum-formed retainer. The study will assess post-treatment tooth stability as the primary outcome, as well as retainer failure, periodontal health, and patient satisfaction. We expect to determine whether the CAD/CAM retainers provide similar or improved stability and clinical outcomes compared with the conventional fixed retainer.
Interventions
Intervention: Following completion of active orthodontic treatment, participants will undergo placement of a mandibular fixed orthodontic retainer and will be randomly allocated to one of three groups:
1. CAD/CAM 0.026-inch stainless steel fixed retainer (intervention group 1)
2. CAD/CAM 0.018-inch stainless steel fixed retainer (intervention group 2)
3. Conventional multi-stranded stainless steel fixed retainer (intervention group 3)
A standardised lower removable vacuum-formed retainer will al
Intervention: Following completion of active orthodontic treatment, participants will undergo placement of a mandibular fixed orthodontic retainer and will be randomly allocated to one of three groups: 1. CAD/CAM 0.026-inch stainless steel fixed retainer (intervention group 1) 2. CAD/CAM 0.018-inch stainless steel fixed retainer (intervention group 2) 3. Conventional multi-stranded stainless steel fixed retainer (intervention group 3) A standardised lower removable vacuum-formed retainer will also be provided to all participants. Delivery: The fixed and removable retainers will be provided face-to-face and individually at the Melbourne Dental Clinic by orthodontic registrars under the supervision of specialist orthodontists with appropriate training and experience in fixed retainer placement and post-orthodontic retention. Fixed retainer placement will be completed during a single clinical visit of approximately 60-90 minutes. Participants will be instructed to wear their removable retainer full-time for the first three months, followed by nightly wear for at least 7 hours per night for 24 months. Fixed retainers will be reviewed every six months, with each review visit lasting approximately 15 minutes. Fixed retainers are intended to remain in situ indefinitely. If breakage occurs, the retainer will be repaired or replaced as clinically appropriate. Participants may also elect to have the fixed retainer removed at any time. The intervention is standard for all patients following orthodontic treatment, irrespective of whether they are part of the trial. Frequency and duration: The retainers will be placed/provided at the completion of active orthodontic treatment. Participants will subsequently attend scheduled follow-up assessments at the following time points: immediately after completion of active orthodontic treatment, followed by 1 months, 6 months, 12 months, 24 months and 5 years, after completing active orthodontic treatment. Adherence: Fixed retainer integrity will be assessed at follow-up visits. Participants will be instructed on the prescribed wear of the removable retainer, with adherence reviewed during follow-up.
Sponsors
The University of Melbourne
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
12 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Patients with good general health aged 12-45 years old at the time of completion of their orthodontic treatment will be invited to participate around 1-2 months prior their expected completion of orthodontic treatment, actual participation begins at the completion of orthodontic treatment. These patients must have had comprehensive fixed or aligner orthodontic treatment, and the presence of all maxillary and mandibular anterior teeth with normal shape and size. Participation for the trial begins at the completion of orthodontic treatment.
Exclusion criteria
Patients with craniofacial disorders/syndromes, lingual appliances, periodontal disease, anterior teeth caries, restorations, hypoplasia or fractures, fluorosis or retreatment.
Outcome results
None listed