Comparison of Efficiency and Effectiveness of Two Types of Bonded Orthodontic Retainers: an RCT.

Comparson of efficiency and effectiveness of twisted/coaxial and linked retainers, placed under relative versus absolute isolation.

Study Overview

• Status: Completed
• Conditions: Relapse
• Intervention / Treatment: Device: Twistflex retainer; Device: Orthoflex retainer

Detailed Description

The domain of orthodontic retention is controversial. Orthodontic retention is the final step in an orthodontic procedure, and is performed after removal of the orthodontic appliance. Its goal is to prevent the relapse in occlusion or positioning of the teeth. Every patient will need some form of retention to maintain the ideal result. The bonded retainer is frequently used in the lower incisor region. It is capable to prevent relapse of orthodontic treatment but prevents tertiary crowding as well. Advantages of fixed retainers are in general no need for compliance and optimal aesthetics. The retention wire can stay in place for many years. Currently, there is a tendency towards lifelong retention. Disadvantages are more plaque and calculus accumulation, and possibly a poorer periodontal index.

Many types of bonded retainers with different properties could be bonded, each with different effects on periodontal health, potentially a different ability to maintain alignment, and different amounts of failure.

Different types of failure of fixed bonded retainers are possible. When the retainer does not stay in place and is debonded, this is is described as failure. It is also possible the retainer maintains bonded but shows unwanted tooth movement in the bonded teeth. This can also be described as a failure.

Bonding of the retention wire is a technique sensitive process. Correct and passive bonding could prevent debonding of the retainers. To eliminate moisture in the bonding process, it is possible to place a rubberdam before bonding the retainer.

One aim of this study is to compare two types of bonded retainer: the standard coaxial or twisted retainer. The other aim is to compare two bonding protocols with and without rubberdam isolation

Two general PICO questions can be formulated:

In an orthodontic patient (P), will fixed retention with a Ortho-flextech tm (Reliance orthodontic products, Itasca III, USA) (I) as compared to a 0.0195 in dead-soft coaxial wire (Respond; Ormco, Orange, Calif). (C) result in a more effective or efficient retention treatment (O)?

In an orthodontic patient (P), will placement of the retainer with rubber dam (I) result in less debonding (O) as compared to relative isolation with cotton rolls (C)?

Efficiency: is the procedure faster or cheaper than the alternative? Effectiveness: is the procedure better in maintaining the end result of treatment than the alternative? Are there less biomechanical or biological side effects?

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University of Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Fixed orthodontic appliances upper and lower jaw
• Patient stays for 2 years in Belgium
• Parents consent
• Proper oral hygiene

Exclusion Criteria:

• Orthognathic surgery
• Craniofacial disorders
• Cleft lip palate patients
• Orthodontic treatment without fixed appliances
• Extra retention other than bonded wire in the lower jaw

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bonding with rubberdam; The retainer is bonded under rubber dam isolation	Device: Twistflex retainer; twisted 0.0195 dead-soft coaxial wire (Respond; Ormco, Orange, Calif); Device: Orthoflex retainer; Ortho-flextech (Reliance orthodontic products, Itasca III, USA)
Active Comparator: Bonding under relative isolation; The retainer is bonded under relative isolation (hygrophormic suction, cotton pads)	Device: Twistflex retainer; twisted 0.0195 dead-soft coaxial wire (Respond; Ormco, Orange, Calif); Device: Orthoflex retainer; Ortho-flextech (Reliance orthodontic products, Itasca III, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Little Irregularity index	Stability of treatment. The index measures the distance, in millimetres, between the contact points of crooked teeth, and then adds them together. Therefore,the Irregularity Index is the sum of all the displaced contacts between the anterior teeth (canine to canine)	Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure of the retainer (1)	Debonding of the retainer is registered, the date and place of reparation.	Through study completion (2 years)
Failure of the retainer (2)	Possible activation (unwanted tooth movement possible torque differences) is checked after treatment.	Through study completion (2 years)
Periodontal index- periodontal status	A periodontal status of the 6 anterior teeth is made, measuring probing depth 6 places per teeth	Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Periodontal index- BoP	Bleeding on probing is registered after the periodontal status (%)	Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Periodontal index- plaque	Plaque measurement (%)	Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Study Chair: Guy De Pauw, Prof, Head of orthodontics

Publications and helpful links

General Publications

• Stormann I, Ehmer U. A prospective randomized study of different retainer types. J Orofac Orthop. 2002 Jan;63(1):42-50. doi: 10.1007/s00056-002-0040-6. English, German.
• Engeler OG, Dalstra M, Arnold DT, Steineck M, Verna C. In vitro comparison of the torsional load transfer of various commercially available stainless-steel wires used for fixed retainers in orthodontics. J Orthod. 2021 Jun;48(2):118-126. doi: 10.1177/1465312520972402. Epub 2020 Nov 24.
• Ferreira LA, Sapata DM, Provenzano MGA, Hayacibara RM, Ramos AL. Periodontal parameters of two types of 3 x 3 orthodontic retainer: a longitudinal study. Dental Press J Orthod. 2019 Aug 1;24(3):64-70. doi: 10.1590/2177-6709.24.3.064-070.oar.
• Sifakakis I, Eliades T, Bourauel C. Residual stress analysis of fixed retainer wires after in vitro loading: can mastication-induced stresses produce an unfavorable effect? Biomed Tech (Berl). 2015 Dec;60(6):617-22. doi: 10.1515/bmt-2015-0013.
• Liebenberg WH. Extending the use of rubber dam isolation: alternative procedures. Part II. Quintessence Int. 1993 Jan;24(1):7-17.
• Arnold DT, Dalstra M, Verna C. Torque resistance of different stainless steel wires commonly used for fixed retainers in orthodontics. J Orthod. 2016 Jun;43(2):121-9. doi: 10.1080/14653125.2016.1155814. Epub 2016 Apr 22.
• Arnone R. Bonding orthodontic lower 3 to 3 retainers with a rubber dam: a second generation step-by-step procedure. Am J Orthod Dentofacial Orthop. 1999 Oct;116(4):432-4. doi: 10.1016/s0889-5406(99)70229-5.
• Aldrees AM, Al-Mutairi TK, Hakami ZW, Al-Malki MM. Bonded orthodontic retainers: a comparison of initial bond strength of different wire-and-composite combinations. J Orofac Orthop. 2010 Jul;71(4):290-9. doi: 10.1007/s00056-010-9947-5. Epub 2010 Jul 30. English, German.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: February 10, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Isolation; Bonding; Orthodontic retainers; Twistflex retainer; Coaxial retainer; OrthoflexTech retainer; Fixed retainer
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: BC-08508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No