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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05250765
Enrollment
114
Registered
2022-02-22
Start date
2020-09-01
Completion date
2023-09-01
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapse

Keywords

Orthodontic retainers, Isolation, Bonding, Twistflex retainer, Coaxial retainer, OrthoflexTech retainer, Fixed retainer

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?

Interventions

DEVICETwistflex retainer

twisted 0.0195 dead-soft coaxial wire (Respond; Ormco, Orange, Calif)

DEVICEOrthoflex retainer

Ortho-flextech (Reliance orthodontic products, Itasca III, USA)

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

4 study groups are possible (2 types of retainers and 2 types of bonding protocol)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Little Irregularity indexMeasured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)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)

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026