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

Primary Purpose

Relapse

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Twistflex retainer
Orthoflex retainer
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapse focused on measuring Orthodontic retainers, Isolation, Bonding, Twistflex retainer, Coaxial retainer, OrthoflexTech retainer, Fixed retainer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bonding with rubberdam

Bonding under relative isolation

Arm Description

The retainer is bonded under rubber dam isolation

The retainer is bonded under relative isolation (hygrophormic suction, cotton pads)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Failure of the retainer (1)
Debonding of the retainer is registered, the date and place of reparation.
Failure of the retainer (2)
Possible activation (unwanted tooth movement possible torque differences) is checked after treatment.
Periodontal index- periodontal status
A periodontal status of the 6 anterior teeth is made, measuring probing depth 6 places per teeth
Periodontal index- BoP
Bleeding on probing is registered after the periodontal status (%)
Periodontal index- plaque
Plaque measurement (%)

Full Information

First Posted
January 11, 2022
Last Updated
December 21, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT05250765
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse
Keywords
Orthodontic retainers, Isolation, Bonding, Twistflex retainer, Coaxial retainer, OrthoflexTech retainer, Fixed retainer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
4 study groups are possible (2 types of retainers and 2 types of bonding protocol)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bonding with rubberdam
Arm Type
Experimental
Arm Description
The retainer is bonded under rubber dam isolation
Arm Title
Bonding under relative isolation
Arm Type
Active Comparator
Arm Description
The retainer is bonded under relative isolation (hygrophormic suction, cotton pads)
Intervention Type
Device
Intervention Name(s)
Twistflex retainer
Intervention Description
twisted 0.0195 dead-soft coaxial wire (Respond; Ormco, Orange, Calif)
Intervention Type
Device
Intervention Name(s)
Orthoflex retainer
Intervention Description
Ortho-flextech (Reliance orthodontic products, Itasca III, USA)
Primary Outcome Measure Information:
Title
Little Irregularity index
Description
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)
Time Frame
Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Secondary Outcome Measure Information:
Title
Failure of the retainer (1)
Description
Debonding of the retainer is registered, the date and place of reparation.
Time Frame
Through study completion (2 years)
Title
Failure of the retainer (2)
Description
Possible activation (unwanted tooth movement possible torque differences) is checked after treatment.
Time Frame
Through study completion (2 years)
Title
Periodontal index- periodontal status
Description
A periodontal status of the 6 anterior teeth is made, measuring probing depth 6 places per teeth
Time Frame
Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Title
Periodontal index- BoP
Description
Bleeding on probing is registered after the periodontal status (%)
Time Frame
Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Title
Periodontal index- plaque
Description
Plaque measurement (%)
Time Frame
Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy De Pauw, Prof
Organizational Affiliation
Head of orthodontics
Official's Role
Study Chair
Facility Information:
Facility Name
University of Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11974451
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.
Results Reference
background
PubMed Identifier
33231109
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.
Results Reference
background
PubMed Identifier
31390451
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.
Results Reference
background
PubMed Identifier
26057215
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.
Results Reference
background
PubMed Identifier
8511260
Citation
Liebenberg WH. Extending the use of rubber dam isolation: alternative procedures. Part II. Quintessence Int. 1993 Jan;24(1):7-17.
Results Reference
background
PubMed Identifier
27104351
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.
Results Reference
background
PubMed Identifier
10511672
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.
Results Reference
background
PubMed Identifier
20676816
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.
Results Reference
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Comparison of Efficiency and Effectiveness of Two Types of Bonded Orthodontic Retainers: an RCT.

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