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

P

Poliklinika Orthonova

Status

Unknown

Conditions

Orthodontic Relapse

Treatments

Device: fixed retainer
Device: removable retainer

Study type

Interventional

Funder types

Other

Identifiers

NCT05121220
66771011

Details and patient eligibility

About

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.

Full 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.

Enrollment

152 estimated patients

Sex

All

Ages

11 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

152 participants in 3 patient groups

fixed mandibular lingual rectangular retainer 0.673 x 0.268 mm
Experimental group
Description:
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).
Treatment:
Device: fixed retainer
fixed mandibular lingual round retainer 0.40 mm
Experimental group
Description:
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).
Treatment:
Device: fixed retainer
removable mandibular retainer
Active Comparator group
Description:
Group without fixed retainer will be wearing removable thermoplastic vacuum-formed Essix retainer
Treatment:
Device: removable retainer

Trial contacts and locations

1

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Central trial contact

Silvija Kanižaj Ugrin, DDM; Stjepan Špalj, PhD

Data sourced from clinicaltrials.gov

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