Actively Recruiting
Retention With Three Different Bonded Retainers: a Multicenter, Randomized Controlled Trial With 5-year Follow-up
Led by Region Örebro County · Updated on 2023-09-08
324
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate and compare the effectiveness, failure rates, and complications of three types of bonded retainers used to maintain the corrected position of lower front teeth after orthodontic treatment. The study focuses on patients who have completed orthodontic treatment with fixed appliances and require a mandibular lingual fixed canine-to-canine retainer. Since retention is crucial to prevent teeth from moving back to their original position, this trial compares traditional and newer retainer types to provide more reliable data on long-term stability and cost-effectiveness. Participants are randomly assigned to one of three groups: the Penta-One multistranded wire, the Ortho-FlexTech stainless steel chain, or the Memotain CAD/CAM fabricated nickel-titanium wire. Half of the patients in each group will have their teeth treated with sandblasting before bonding, while the other half will not. The bonding procedures involve cleaning and preparing the teeth surfaces, applying primer and composite materials, and securing the retainers using precise techniques specific to each retainer type. Follow-up visits are scheduled at baseline, 6 months, 1 year, 2 years, and 5 years after debonding. During the study, participants will have digital impressions and intraoral photographs taken at each visit to assess tooth position and retainer condition. Researchers will monitor retainer failures such as debonding or breakage and record any complications like plaque, calculus, or gum inflammation. They will also analyze the costs associated with each retainer type and investigate whether sandblasting improves retainer durability. The primary outcome is the failure rate of each retainer over the observation period, with additional assessments of complications and cost-effectiveness conducted at 2 and 5 years.
CONDITIONS
Brief Title
Retention With Three Different Bonded Retainers a Multicenter, Randomized Controlled Trial With 5-year Follow-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients requiring mandibular lingual fixed canine-to-canine retainer after undergoing orthodontic treatment with fixed appliances
- Sound enamel on the lingual surface
- Calculus-free lingual surface in the lower anterior segment
You will not qualify if you...
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single visit for bonding procedure
Participants receive one of three types of bonded mandibular lingual fixed retainers after orthodontic treatment. The bonding procedure includes cleaning, polishing, etching, and applying composite material to secure the retainer on the lower six anterior teeth. For one retainer type, a digital scan is taken prior to bonding. Half of the retainers are bonded with sandblasted enamel and half without.
1 visit (in-person)
Duration - 5 years
Participants attend scheduled follow-up visits for impressions, digital scans, and intraoral photographs to assess retainer failure and complications. Follow-ups occur at baseline (immediately after debonding), 6 months, 1 year, 2 years, and 5 years post-bonding.
5 visits (in-person) at baseline, 6 months, 1 year, 2 years, and 5 years
Trial Site Locations
Total: 2 locations
1
Universitat Internacional de Catalunya, Department of Orthodontics
Barcelona, Catalonia, Spain
Not Yet Recruiting
2
Postgraduate Dental Education Center
Örebro, Sweden, SE-70111
Actively Recruiting
Research Team
F
Farhan Bazargani, DDS, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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