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Efficacy and Cost-effectiveness of Orthodontic Retention Protocols

Efficacy and Cost-effectiveness of Orthodontic Retention Protocols

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05121220
Acronym
orthoretenti
Enrollment
152
Registered
2021-11-16
Start date
2020-11-15
Completion date
2023-11-15
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Relapse

Keywords

retention wire, fixed retainer, orthodontic therapy

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.

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.

Interventions

bonded lingual mandibular fixed retainer on frontal teeth 33-43

DEVICEremovable retainer

thermoplastic vacuum-formed removable mandibular retainer

Sponsors

University of Zagreb School of Dental Medicine, Zagreb, Croatia
CollaboratorUNKNOWN
University of Rijeka Faculty of Dental Medicine, Rijeka, Croatia
CollaboratorUNKNOWN
Poliklinika Orthonova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

finished orthodontic treatment, participants must have all permanent teeth

Exclusion criteria

hypodontia, missing teeth

Design outcomes

Primary

MeasureTime frameDescription
severity of relapse (unexpected tooth movement in mandibular frontal area) at 1 year1 yearthe 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
extent of biofilm accumulation at 3 years3 yearsthe 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
extent of biofilm accumulation at 2 years2 yearsthe 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
incidence of retainer failure (debonding, breakage) at 3 years3 yearspercentage 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
incidence of retainer failure (debonding, breakage) at 2 years2 yearspercentage 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
severity of relapse (unexpected tooth movement in mandibular frontal area) at 3 years3 yearsthe 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
severity of relapse (unexpected tooth movement in mandibular frontal area) at 2 years2 yearsthe 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

Secondary

MeasureTime frameDescription
changes of intercanine width2 years, 3 yearsthe 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
incidence of intercanine width change3 yearspercentage 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
extent of calculus accumulation at 2 years2 yearsthe 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
extent of calculus accumulation at 3 years3 yearsthe 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

Other

MeasureTime frameDescription
incidence of relapse at 3 years3 yearsthe 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
loss of productivity3 yearsthe 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
costs total3 yearscalculation of costs of retention: failures and new retainers in euros
satisfaction with stability of results in retention period3 yearsParticipant'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
duration of orthodontic treatment in months1 yearthe unabbreviated scale title: numerical rating scale the minimum and maximum values: 0,30
extent of gingivitis at 3 years3 yearsthe 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
incidence of relapse at 2 years2 yearsthe 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
extent of gingivitis at 2 years2 yearsthe 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

Countries

Croatia

Contacts

Primary ContactSilvija Kanižaj Ugrin, DDM
kanizaj.ugrin@gmail.com00385915232860
Backup ContactStjepan Špalj, PhD
stjepan.spalj@fdmri.uniri.hr00385916119853

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026