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

NCT04828096 | Recruiting

• 1 other identifier: 2020-04104
• Study Type: interventional
• Target: 324
• Locations: 2 countries
• Sites: 2

Brief 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

Conditions

Dental Malocclusion; Stability

Keywords

Orthodontic retention, Stability, Long-term

Outcome Measures

Primary Outcomes (2)

• Failure rate

  Failure rate/breakage of the retainers during the observation periods

  2-year follow-up

• Failure rate

  Failure rate/breakage of the retainers during the observation periods

  5-year follow-up

Secondary Outcomes (6)

• Complications

  2-year follow-up

• Cost-effectiveness

  2-year follow-up

• Effect of micro-etching

  2-year follow-up

• Complications

  5-year follow-up

• Cost-effectiveness

  5-year follow-up

Study Arms (3)

Penta-one retainer

ACTIVE COMPARATOR

Penta-one retainer is one wire that is been in use for many years. Penta-one retainer is to be bonded on the lower anterior 6 teeth (canine-to-canine)- Half of the retainers are going to be bonded with sandblasted enamel and half without.

Other: Orthodontic retention

Ortho-FlexTech retainer

EXPERIMENTAL

Ortho-Flextech chain wire is relatively new in the market and needs to be evaluated. Ortho-Flextech retainer is to be bonded on the lower anterior 6 teeth (canine-to-canine)- Half of the retianers are going to be bonded with sandblasted enamel and half without.

Other: Orthodontic retention

Memotain retainer

EXPERIMENTAL

Memotain wire is relatively new in the market. It requires digital scanning and the technique is said to be very exact. Memotain retainer is to be bonded on the lower anterior 6 teeth (canine-to-canine)- Half of the retianers are going to be bonded with sandblasted enamel and half without.

Other: Orthodontic retention

Interventions

Orthodontic retention OTHER

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

Memotain retainer; Ortho-FlexTech retainer; Penta-one retainer

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (2)

Universitat Internacional de Catalunya, Department of Orthodontics

Barcelona, Catalonia, Spain

NOT YET RECRUITING

Postgraduate Dental Education Center

Örebro, SE-70111, Sweden

RECRUITING

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Farhan Bazargani, DDS, PhD

CONTACT

+46196024050; farhan.bazargani@regionorebrolan.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD, Associate professor

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Study Start: March 25, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); SE (1)