Clinical trial NCT05121220: Efficacy and Cost-effectiveness of Orthodontic Retention Protocols
Official title: Efficacy and Cost-effectiveness of Orthodontic Retention Protocols
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Relapse
Keywords: retention wire
fixed retainer
orthodontic therapy
Lead sponsor: Poliklinika Orthonova
Sponsor class: OTHER
Collaborators: name: University of Zagreb School of Dental Medicine, Zagreb, Croatia
name: University of Rijeka Faculty of Dental Medicine, Rijeka, Croatia
First posted: 2021-11-16
Enrollment: 152
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: severity of relapse (unexpected tooth movement in mandibular frontal area) at 1 year
timeFrame: 1 year
measure: severity of relapse (unexpected tooth movement in mandibular frontal area) at 2 years
timeFrame: 2 years
measure: severity of relapse (unexpected tooth movement in mandibular frontal area) at 3 years
timeFrame: 3 years
measure: incidence of retainer failure (debonding, breakage) at 2 years
timeFrame: 2 years
measure: incidence of retainer failure (debonding, breakage) at 3 years
timeFrame: 3 years
measure: extent of biofilm accumulation at 2 years
timeFrame: 2 years
measure: extent of biofilm accumulation at 3 years
timeFrame: 3 years
Secondary outcomes:
measure: incidence of intercanine width change
timeFrame: 3 years
measure: changes of intercanine width
timeFrame: 2 years, 3 years
measure: extent of calculus accumulation at 2 years
timeFrame: 2 years
measure: extent of calculus accumulation at 3 years
timeFrame: 3 years
Other outcomes:
measure: incidence of relapse at 2 years
timeFrame: 2 years
measure: incidence of relapse at 3 years
timeFrame: 3 years
measure: extent of gingivitis at 2 years
timeFrame: 2 years
measure: extent of gingivitis at 3 years
timeFrame: 3 years
measure: duration of orthodontic treatment in months
timeFrame: 1 year
measure: satisfaction with stability of results in retention period
timeFrame: 3 years
measure: costs total
timeFrame: 3 years
measure: loss of productivity
timeFrame: 3 years
Locations:
city: Zagreb
country: Croatia
facility: Poliklinika Orthonova
Study officials:
affiliation: Poliklinika Orthonova
name: Silvija Kanižaj Ugrin, DDM
role: PRINCIPAL_INVESTIGATOR
References: