RCT for the Effectiveness of 3 Orthodontic Retention Schemes on Post-treatment Stability and Gingival Recession

Gingival Recession Clinical Trial

— OrthRe10tion  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02742493
• Other study ID #: 294
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 2023

Study information

• Verified date: May 2022
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: October 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingival Recession
• Recurrence
• Relapse

Intervention

Other:
• 0.028 bonded to canines
lower fixed canine and canine retainer (0.028 stainless steel bonded to canines) and upper removable Hawley (Intervention A)
• 0.027 7-strand bonded to all 6
lower fixed canine to canine retainer (7-strand Twistflex 0.027 bonded to all six anterior teeth) and upper removable Hawley (Intervention B)
• removable Hawley-type
lower Hawley-type and upper Hawley removable retainer (Control)

Locations

Country	Name	City	State
Greece	Department of Orthodontics, School of Dentistry, University of Athens	Athens	Goudi

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Little's Irregularity Index in the mandible (mm)		1 year in retention, 2 years in retention, 5 years in retention
Primary	Changes in Intercanine width in the mandible (mm)		1 year in retention, 2 years in retention, 5 years in retention
Primary	Changes in Interpremolar width in the mandible (mm)		1 year in retention, 2 years in retention, 5 years in retention
Primary	Changes in Intermolar width in the mandible (mm)		1 year in retention, 2 years in retention, 5 years in retention
Primary	Changes in Arch length in the mandible (mm)		1 year in retention, 2 years in retention, 5 years in retention
Secondary	Changes in Gingival Recessions on the lingual surfaces of the six lower anterior teeth		1 year in retention, 2 years in retention, 5 years in retention
Secondary	Changes in Intercanine width in the maxilla (mm)		1 year in retention, 2 years in retention, 5 years in retention
Secondary	Changes in Interpremolar width in the maxilla (mm)		1 year in retention, 2 years in retention, 5 years in retention
Secondary	Changes in Intermolar width in the maxilla (mm)		1 year in retention, 2 years in retention, 5 years in retention
Secondary	Changes in Arch length in the maxilla (mm)		1 year in retention, 2 years in retention, 5 years in retention
Secondary	Changes in Overbite and Overjet (mm)		1 year in retention, 2 years in retention, 5 years in retention
Secondary	Accidental bond failures of fixed retainers or breakages of removable ones		1 year in retention, 2 years in retention, 5 years in retention
Secondary	Leveling or torque related problems of the lower anterior teeth		1 year in retention, 2 years in retention, 5 years in retention