Clinical trial NCT05250765: Comparison of Efficiency and Effectiveness of Two Types of Bonded Orthodontic Retainers: an RCT.
Official title: Comparison of Efficiency and Effectiveness of Two Types of Bonded Orthodontic Retainers: an RCT.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relapse
Keywords: Orthodontic retainers
Isolation
Bonding
Twistflex retainer
Coaxial retainer
OrthoflexTech retainer
Fixed retainer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 114
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 study groups are possible (2 types of retainers and 2 types of bonding protocol)
Primary purpose: TREATMENT

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

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?

Eligibility criteria: 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

Primary outcomes:
measure: Little Irregularity index
timeFrame: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Secondary outcomes:
measure: Failure of the retainer (1)
timeFrame: Through study completion (2 years)
measure: Failure of the retainer (2)
timeFrame: Through study completion (2 years)
measure: Periodontal index- periodontal status
timeFrame: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
measure: Periodontal index- BoP
timeFrame: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
measure: Periodontal index- plaque
timeFrame: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University of Ghent
Study officials:
affiliation: Head of orthodontics
name: Guy De Pauw, Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Liebenberg WH. Extending the use of rubber dam isolation: alternative procedures. Part II. Quintessence Int. 1993 Jan;24(1):7-17.
citation: 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.
citation: 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.
citation: 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.