Clinical trial NCT02742493: RCT for the Effectiveness of 3 Orthodontic Retention Schemes on Post-treatment Stability and Gingival Recession
Official title: A Single-center, 3-arm, Parallel-group Randomized Controlled Trial to Evaluate the Effectiveness of Three Orthodontic Retention Schemes in Preventing Post-treatment Mandibular Arch Changes and Gingival Recession in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Relapse
Gingival Recession
Keywords: relapse
irregularity
recession
retention
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to assess the effectiveness of three different retention schemes used to maintain tooth position after orthodontic treatment with fixed orthodontic appliances (stability) and to evaluate possible association between retention scheme and gingival recessions on the lingual surfaces of the lower anterior teeth seen for up to 5 years post-treatment. Moreover the possible association between primary relapse tendency and long term occlusal stability will be evaluated.

Detailed description: This is a randomized, controlled, single-center, equivalence trial with three parallel groups and an allocation ratio of 1:1:1, that aims to investigate the effectiveness of 3 orthodontic retention schemes on post-treatment mandibular arch stability and gingival recession.

Eligibility criteria: Inclusion Criteria:

* Both sexes
* Age between 10 and 16 years
* At the finishing stage of orthodontic treatment, programmed for debonding
* Class I to Class II molar relationship before the beginning of orthodontic treatment
* Non-extraction treatment plan with fixed straight-wire appliances
* Space deficiencies and irregularity of no more than 6mm in the maxillary/ mandibular arch (Irregularity Index)

Exclusion Criteria:

* No missing teeth, impacted teeth or other dental anomalies
* No congenital anomalies/ syndromes

Primary outcomes:
measure: Changes in Little's Irregularity Index in the mandible (mm)
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
measure: Changes in Intercanine width in the mandible (mm)
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
measure: Changes in Interpremolar width in the mandible (mm)
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
measure: Changes in Intermolar width in the mandible (mm)
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
measure: Changes in Arch length in the mandible (mm)
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
Secondary outcomes:
measure: Changes in Gingival Recessions on the lingual surfaces of the six lower anterior teeth
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
measure: Changes in Intercanine width in the maxilla (mm)
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
measure: Changes in Interpremolar width in the maxilla (mm)
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
measure: Changes in Intermolar width in the maxilla (mm)
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
measure: Changes in Arch length in the maxilla (mm)
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
measure: Changes in Overbite and Overjet (mm)
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
measure: Accidental bond failures of fixed retainers or breakages of removable ones
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
measure: Leveling or torque related problems of the lower anterior teeth
timeFrame: 1 year in retention, 2 years in retention, 5 years in retention
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Department of Orthodontics, School of Dentistry, University of Athens
state: Goudi
Study officials:
affiliation: National and Kapodistrian University of Athens
name: Iosif Sifakakis, Lecturer
role: PRINCIPAL_INVESTIGATOR
References: