Efficacy and Cost-effectiveness of Orthodontic Retention Protocols

NCT05121220 | Unknown

• 1 other identifier: 66771011
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Objective is to assess changes of dentition and periodontium, and hygiene in retention after the end of the active phase of orthodontic treatment, and relationship with gender, type of retention appliance, pre-therapeutic condition of dentition and duration of active phase of treatment.

Conditions

Orthodontic Relapse

Keywords

retention wire; fixed retainer; orthodontic therapy

Outcome Measures

Primary Outcomes (7)

• severity of relapse (unexpected tooth movement in mandibular frontal area) at 1 year

  the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome

  1 year

• severity of relapse (unexpected tooth movement in mandibular frontal area) at 2 years

  the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome

  2 years

• severity of relapse (unexpected tooth movement in mandibular frontal area) at 3 years

  the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome

  3 years

• incidence of retainer failure (debonding, breakage) at 2 years

  percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result

  2 years

• incidence of retainer failure (debonding, breakage) at 3 years

  percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result

  3 years

• extent of biofilm accumulation at 2 years

  the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result

  2 years

• extent of biofilm accumulation at 3 years

  the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result

  3 years

Secondary Outcomes (4)

• incidence of intercanine width change

  3 years

• changes of intercanine width

  2 years, 3 years

• extent of calculus accumulation at 2 years

  2 years

• extent of calculus accumulation at 3 years

  3 years

Other Outcomes (8)

• incidence of relapse at 2 years

  2 years

• incidence of relapse at 3 years

  3 years

• extent of gingivitis at 2 years

  2 years

Study Arms (3)

fixed mandibular lingual rectangular retainer 0.673 x 0.268 mm

EXPERIMENTAL

0.673 x 0.268 mm 8-stranded wire Bond A Braid (Reliance Orthodontic Products, USA) will be bonded in mandible canine to canine on each tooth using Filtek flowable composite (Ivoclar Vivadent, Lichtenstein) and Multilink adhesive (3M, USA).

Device: fixed retainer

fixed mandibular lingual round retainer 0.40 mm

EXPERIMENTAL

0.40 mm round 6-stranded wire (Forestadent, Germany) will be bonded on 6 mandibular frontal teeth, canine to canine on each tooth using Filtek flowable composite (Ivoclar Vivadent, Lichtenstein) and Multilink adhesive (3M, USA).

Device: fixed retainer

removable mandibular retainer

ACTIVE COMPARATOR

Group without fixed retainer will be wearing removable thermoplastic vacuum-formed Essix retainer

Device: removable retainer

Interventions

fixed retainer DEVICE

bonded lingual mandibular fixed retainer on frontal teeth 33-43

fixed mandibular lingual rectangular retainer 0.673 x 0.268 mm; fixed mandibular lingual round retainer 0.40 mm

removable retainer DEVICE

thermoplastic vacuum-formed removable mandibular retainer

removable mandibular retainer

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Poliklinika Orthonova: lead
• University of Zagreb School of Dental Medicine, Zagreb, Croatia: collaborator
• University of Rijeka Faculty of Dental Medicine, Rijeka, Croatia: collaborator

Study Sites (1)

Poliklinika Orthonova

Zagreb, 10000, Croatia

RECRUITING

Related Publications (1)

• Kanizaj Ugrin S, Spalj S. Comparison of efficacy of thermoplastic retainer with round and rectangular bonded lingual wire retainer in the mandible two years after orthodontic treatment: a randomised controlled trial. Clin Oral Investig. 2024 Mar 1;28(3):183. doi: 10.1007/s00784-024-05572-y.

  PMID: 38424224 DERIVED

MeSH Terms

Interventions

Orthodontic Appliances, Fixed

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Silvija Kanižaj Ugrin, DDM

  Poliklinika Orthonova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvija Kanižaj Ugrin, DDM

CONTACT

00385915232860; kanizaj.ugrin@gmail.com

Stjepan Špalj, PhD

CONTACT

00385916119853; stjepan.spalj@fdmri.uniri.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist, Orthodontic specialist

Study Record Dates

• First Submitted: October 2, 2021
• First Posted: November 16, 2021
• Study Start: November 15, 2020
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2023
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)