RecruitingNot ApplicableNCT04828096

Retention With Three Different Bonded Retainers a Multicenter, Randomized Controlled Trial With 5-year Follow-up

Retention With Three Different Bonded Retainers: a Multicenter, Randomized Controlled Trial With 5-year Follow-up


Sponsor

Region Örebro County

Enrollment

324 participants

Start Date

Mar 25, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

One of major challenges in orthodontics is to inhibit relapse and ensure stability of treatment outcomes. Retention is the phase of orthodontic treatment that attempts to keep teeth in the corrected position after correction with orthodontic braces. Without retention there is a tendency for the teeth to return to their initial position (1). Retention is usually necessary to overcome the elastic recoil of the periodontal supporting fibers and to allow remodeling of the alveolar bone. The bonded orthodontic lingual retainer constructed from composite and orthodontic wires provides an esthetic and efficient system for maintained retention and has been shown to be an effective means of retaining aligned anterior teeth in the post treatment position in the long term. This has been in popular use as a method of retention since the late 1970s (2). The traditional retainers, which are still in use, are multi-strand stainless steel retainers such as Penta-one® 0.0215 (Masel Orthodontics, Carlsbad, CA, USA). The main problem with multistrand stainless steel retainers is their high rate of failure. Clinical studies indicate that 5% to 37% of mandibular retainers fail during retention in some form, either bond failure or wire breakage (3-5). Reliance Orthodontic Products, Inc. (Itasca, IL, USA) recently introduced a bonded retainer system (Ortho-Flextech™ chain). This retainer's bonding is claimed to be quick and easy by reducing chairside time and eliminating laboratory costs (6). One other recently introduced retainer is Memotain™ (CA-Digital in Mettmann, Germany). Memotain is a CAD/CAM fabricated lingual retainer made of 0.014 X 0.014-inch rectangular nickel-titanium. The wire is highly flexible and custom cut to precisely adapt to the patient's lingual tooth anatomy. According to manufacturer, Memotain offers numerous perceived advantages to traditional multistranded lingual wires, including no need for wire measuring or bending, individually optimized placement, greater accuracy of fit, tighter interproximal adaptation, less tongue irritation, better durability, and resistance to microbial colonization (6). However, randomized clinical trials are necessary to determine whether these advantages are substantiated with scientific data. A recent review by the Cochrane group concluded that to date there is insufficient evidence to single out any particular retention strategy as the preferred method: it was recommended that future studies should include true randomization, reporting of dropouts, adequate sample size calculation, and a minimum follow-up period of 3 months (8). Thus, the aims of this multicenter, randomised controlled trial are: * To compare and evaluate the effectiveness and failure rate of Penta-one multistrand, Ortho-Flextech and Memotain retainers with each other * To compare the possible complications between the three retainers over time * To establish the cost-effectiveness of the three retainers * To evaluate the effectiveness of sandblasting in the retention of the wires


Eligibility

Min Age: 10 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at three different types of dental retainers — the thin wires glued behind your lower front teeth after braces — to see which one holds up best over five years. After orthodontic treatment, retainers are essential to stop your teeth from shifting back. Researchers want to find out which bonded retainer design works the best and lasts the longest. The study is being done at multiple dental centers and randomly assigns patients to one of three retainer types. Participants will be followed for five years with regular check-ups to track whether the retainer stays intact and whether teeth stay in their corrected positions. You may be eligible if: - You need a lower front (canine-to-canine) fixed retainer after braces - You are between 10 and 60 years old - Your tooth enamel on the back of your lower front teeth is healthy - Your lower front teeth are free of tartar buildup You may NOT be eligible if: - You have damaged enamel on the back of your lower front teeth - You have significant tartar or calculus on your lower front teeth Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROrthodontic retention

The stability of the mandibular anterior teeth after two resp. 5 years of retention


Locations(2)

Universitat Internacional de Catalunya, Department of Orthodontics

Barcelona, Catalonia, Spain

Postgraduate Dental Education Center

Örebro, Sweden

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NCT04828096


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