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

Sponsor
University Hospital, Ghent (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05250765
Collaborator
(none)
100
1
2
36
2.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Twistflex retainer
  • Device: Orthoflex retainer
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
4 study groups are possible (2 types of retainers and 2 types of bonding protocol)4 study groups are possible (2 types of retainers and 2 types of bonding protocol)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Efficiency and Effectiveness of Two Types of Bonded Orthodontic Retainers: an RCT.
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Little Irregularity index [Measured 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 Outcome Measures

  1. Failure of the retainer (1) [Through study completion (2 years)]

    Debonding of the retainer is registered, the date and place of reparation.

  2. Failure of the retainer (2) [Through study completion (2 years)]

    Possible activation (unwanted tooth movement possible torque differences) is checked after treatment.

  3. Periodontal index- periodontal status [Measured 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

  4. Periodontal index- BoP [Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)]

    Bleeding on probing is registered after the periodontal status (%)

  5. Periodontal index- plaque [Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)]

    Plaque measurement (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Ghent Ghent Belgium 9000

Sponsors and Collaborators

  • University Hospital, Ghent

Investigators

  • Study Chair: Guy De Pauw, Prof, Head of orthodontics

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT05250765
Other Study ID Numbers:
  • BC-08508
First Posted:
Feb 22, 2022
Last Update Posted:
Feb 22, 2022
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Ghent
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 22, 2022