Clinical trial NCT05926934: The Effectiveness of 3 Orthodontic Fixed Retention Schemes on Post-treatment Stability and Gingival Recession
Official title: A Single-center, 3-arm, Parallel-group Randomized Controlled Trial to Evaluate Bond Failures and the Effectiveness of Three Orthodontic Retention Schemes in Preventing Post-treatment Mandibular Arch Changes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Relapse
Orthodontic Retention
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 90
Sex: ALL
Minimum age (years): 13
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is high possibility of relapse of the lower anterior teeth after orthodontic treatment. Relapse is related with the initial orthodontic anomaly, pathology of surrounding tissues, patient's age and sex and compliance and the retention protocol applied. The options for the later are various. Permanent fixed retainers are considered of the most common ones and vastly vary based of composition. There are fixed retainers distinguished for their composition (SS, β-NiTi, fiber-reinforced composite retainers) or for their shape and dimensions (round or rectangular shape and single-strand or multi-strand respectively), and/or for the teeth they are placed on (canine and canine or canine to canine). Fixed retainers may require patient's cooperation , nevertheless debond failure rate varies between 0.1-53%.

The aim of this prospective randomized clinical study is to compare failure incidents and retention effect on lower anterior teeth after orthodontic finish between three different types of fixed retainers. There will be 3 arms studied in this research: a) single strand 0.016x0.022'' β-Ti canine to canine, b) 0.028'' SS canine to canine and c) 0.027'' multi-strand twistflex canine to canine. Variables such as repeatability of failures, and undesired tooth movements will be measured. Measurements will be repeated every 3 months after patient's recruitment in this study, for one year period (12 months in total). Intraoral scans will be collected during baseline (fixed retainer insertion) and after 12 months.


Eligibility criteria: Inclusion Criteria:

* Patients treated with fixed orthodontic appliances (Roth 0.018'' slot at their final finishing stage)
* Patients with fixed orthodontic appliances at least between their lower first premolars
* No lower anterior teeth crowding (total irregularity index score = 0)
* Patients with no need of removable retention appliances on their lower teeth

Exclusion Criteria:

* Active caries on adjacent or lingual surfaces of lower anterior teeth
* Active periodontitis
* Supragingival calculus
* Gum bleeding during bonding of fixed retainer
* Gingival pocket depth greater than 3mm
* Syndromes or other anomalies of the craniofacial complex or other mental illness
* Missing or impacted teeth or other dental anomalies
* Congenital anomalies/syndromes
* Allergies regarding the alloys of fixed retainers
* Need for chemoprevention before data collection of periodontal indexes
* Diabetes
* Smoking
* Usage of antibiotics
* Pregnancy
* Participation in other clinical trials

Primary outcomes:
measure: Number of teeth that failed regarding the bonding strength
timeFrame: baseline-3 months
measure: Number of teeth that failed regarding the bonding strength
timeFrame: 3 months-6 months
measure: Number of teeth that failed regarding the bonding strength
timeFrame: 6 months-9 months
measure: Number of teeth that failed regarding the bonding strength
timeFrame: 9 months-1 year
measure: Repeatability of bonding strength failure per patient and per tooth
timeFrame: baseline-3 months
measure: Repeatability of bonding strength failure per patient and per tooth
timeFrame: 3 months-6 months
measure: Repeatability of bonding strength failure per patient and per tooth
timeFrame: 6 months-9months
measure: Repeatability of bonding strength failure per patient and per tooth
timeFrame: 9months-1 year
measure: Breakage of fixed retainer wires
timeFrame: baseline-3 months
measure: Breakage of fixed retainer wires
timeFrame: 3 months-6 months
measure: Breakage of fixed retainer wires
timeFrame: 6 months-9 months
measure: Breakage of fixed retainer wires
timeFrame: 9 months-1 year
measure: Space discrepancy (Little index)(in mm)
timeFrame: baseline-3 months
measure: Space discrepancy (Little index)(in mm)
timeFrame: 3 months-6 months
measure: Space discrepancy (Little index)(in mm)
timeFrame: 6 months-9 months
measure: Space discrepancy (Little index)(in mm)
timeFrame: 9 months-1 year
measure: Mandibular intercanine distance
timeFrame: baseline-3 months
measure: Mandibular intercanine distance
timeFrame: 3 months-6 months
measure: Mandibular intercanine distance
timeFrame: 6 months-9 months
measure: Mandibular arch length (in mm)
timeFrame: 9 months-1 year
Secondary outcomes:
measure: Tooth rotations in lower anterior teeth
timeFrame: baseline-3 months
measure: Tooth rotations in lower anterior teeth
timeFrame: 3 months-6 months
measure: Tooth rotations in lower anterior teeth
timeFrame: 6 months-9 months
measure: Tooth rotations in lower anterior teeth
timeFrame: 9 months-1 year
measure: Extrusion in lower anterior teeth
timeFrame: baseline-3 months
measure: Extrusion in lower anterior teeth
timeFrame: 3 months-6 months
measure: Extrusion in lower anterior teeth
timeFrame: 6 months-9 months
measure: Extrusion in lower anterior teeth
timeFrame: 9 months-1 year
measure: Tip inclinations anteroposteriorly
timeFrame: baseline-3 months
measure: Tip inclinations anteroposteriorly
timeFrame: 3 months-6 months
measure: Tip inclinations anteroposteriorly
timeFrame: 6 months-9 months
measure: Tip inclinations anteroposteriorly
timeFrame: 9 months -1 year
Other outcomes:
Locations:
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens, School of Dentistry, Departments of Orthodontics
state: Attiki
Study officials:
References: