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

NCT05250765 | Completed

• 1 other identifier: BC-08508
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapse

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Failure of the retainer (1)

  Through study completion (2 years)

• Failure of the retainer (2)

  Through study completion (2 years)

• Periodontal index- periodontal status

  Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)

• Periodontal index- BoP

  Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)

• Periodontal index- plaque

  Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)

Study Arms (2)

Bonding with rubberdam

EXPERIMENTAL

The retainer is bonded under rubber dam isolation

Device: Twistflex retainer; Device: Orthoflex retainer

Bonding under relative isolation

ACTIVE COMPARATOR

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

Device: Twistflex retainer; Device: Orthoflex retainer

Interventions

Twistflex retainer DEVICE

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

Bonding under relative isolation; Bonding with rubberdam

Orthoflex retainer DEVICE

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

Bonding under relative isolation; Bonding with rubberdam

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University of Ghent

Ghent, 9000, Belgium

Location

Related Publications (8)

• 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.

  PMID: 11974451 BACKGROUND

• 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.

  PMID: 33231109 BACKGROUND

• 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.

  PMID: 31390451 BACKGROUND

• 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.

  PMID: 26057215 BACKGROUND

• Liebenberg WH. Extending the use of rubber dam isolation: alternative procedures. Part II. Quintessence Int. 1993 Jan;24(1):7-17.

  PMID: 8511260 BACKGROUND

• 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.

  PMID: 27104351 BACKGROUND

• 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.

  PMID: 10511672 BACKGROUND

• 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.

  PMID: 20676816 BACKGROUND

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guy De Pauw, Prof

  Head of orthodontics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 22, 2022
• Study Start: September 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: September 1, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)