Efficacy and Cost-effectiveness of Orthodontic Retention Protocols (orthoretenti)

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.

Study Overview

• Status: Recruiting
• Conditions: Orthodontic Relapse
• Intervention / Treatment: Device: fixed retainer; Device: removable retainer

Detailed Description

A total of 152 subjects will be recruited and randomly assigned into three groups. First group will have a square 8-stranded 0.673x0.268 mm retainer wire bonded in mandibular teeth after completing the active phase of comprehensive orthodontic treatment with fixed appliances. Retainer will be bonded on lingual site canine to canine on each tooth. Second group will have a round 6-stranded 0.40 mm retainer in mandible. Third group will be without fixed retainer, only with thermoplastic vacuum-formed removable Essix retainer in mandible.

Subjects will be examined before orthodontic treatment (T0), upon completion of treatment (T1), six months in retention (T2), two years (T3) and three years in retention (T4). Changes in intercanine width, relapse (unexpected tooth movements), retainer failure, accumulation of biofilm, calculus and gingivitis will be assessed.

• Study Type: Interventional
• Enrollment (Anticipated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvija Kanižaj Ugrin, DDM; Phone Number: 00385915232860; Email: kanizaj.ugrin@gmail.com
• Study Contact Backup: Name: Stjepan Špalj, PhD; Phone Number: 00385916119853; Email: stjepan.spalj@fdmri.uniri.hr

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • Poliklinika Orthonova
    • Contact: Silvija Kanižaj Ugrin, DMD; Phone Number: +385915232860; Email: kanizaj.ugrin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: finished orthodontic treatment, participants must have all permanent teeth Exclusion Criteria: hypodontia, missing teeth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fixed mandibular lingual rectangular retainer 0.673 x 0.268 mm; 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; bonded lingual mandibular fixed retainer on frontal teeth 33-43
Experimental: fixed mandibular lingual round retainer 0.40 mm; 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; bonded lingual mandibular fixed retainer on frontal teeth 33-43
Active Comparator: removable mandibular retainer; Group without fixed retainer will be wearing removable thermoplastic vacuum-formed Essix retainer	Device: removable retainer; thermoplastic vacuum-formed removable mandibular retainer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of intercanine width change	percentage of cases with intercanine width change, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result	3 years
changes of intercanine width	the unabbreviated scale title: intercanine width change in millimeters, the minimum and maximum values 0,5, higher scores mean a worse outcome, lower result mean a better outcome	2 years, 3 years
extent of calculus accumulation at 2 years	the unabbreviated scale title: Calculus Surface Index (CSI)-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 outcome	2 years
extent of calculus accumulation at 3 years	the unabbreviated scale title: Calculus Surface Index (CSI)-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 outcome	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of relapse at 2 years	the unabbreviated scale title: percentage of relapsed cases; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome	2 years
incidence of relapse at 3 years	the unabbreviated scale title: percentage of relapsed cases; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome	3 years
extent of gingivitis at 2 years	the unabbreviated scale title: Bleeding on probing (BOP)-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 gingivitis at 3 years	the unabbreviated scale title: Bleeding on probing (BOP)-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
duration of orthodontic treatment in months	the unabbreviated scale title: numerical rating scale the minimum and maximum values: 0,30	1 year
satisfaction with stability of results in retention period	Participant's satisfaction with stability of results as assessed using a 5-point Likert scale. Scores range from "very unsatisfied" (1) to "very satisfied" (5). Higher scores mean a better outcome, lower scores mean a worse outcome	3 years
costs total	calculation of costs of retention: failures and new retainers in euros	3 years
loss of productivity	the unabbreviated scale title: number of check-ups in retention period; the minimum and maximum values 0,10; higher scores mean a worse outcome, lower scores mean a better result the minimum and maximum values: 0,30	3 years

Collaborators and Investigators

• Sponsor: Poliklinika Orthonova
• Collaborators: University of Zagreb School of Dental Medicine, Zagreb, Croatia; University of Rijeka Faculty of Dental Medicine, Rijeka, Croatia
• Investigators: Principal Investigator: Silvija Kanižaj Ugrin, DDM, Poliklinika Orthonova

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2020
• Primary Completion (Anticipated): November 15, 2022
• Study Completion (Anticipated): November 15, 2023

Study Registration Dates

• First Submitted: October 2, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: fixed retainer; retention wire; orthodontic therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: 66771011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: on request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No