Does Double With Regular Monitoring Prevent Undesired Tooth Movement?

Malocclusion Clinical Trial

Official title:

Does Double (Fixed and Removable Orthodontic Retention) With Regular Monitoring Prevent Undesired Tooth Movement?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05626335
• Other study ID #: KB-0012/74/10/2020/Z
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: September 9, 2022

Study information

• Verified date: October 2022
• Source: Pomeranian Medical University Szczecin
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of observational study is to learn about the stability of orthodontic treatment results in orthodontic patients during retention phase of treatment.

Description:

The aim of the present study was to three-dimensionally analyze tooth movement in retention phase of treatment and wherever double effectively retention prevents it.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 9, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Non-extraction treatment

• No hypodontia

• Normal occlusion after treatment (Class I occlusion), perfect alignment

• Normal overjet and overbite

• Double retention including fixed retainer bonded from canine to canine in both dental arches and thermally formed removable splint

Exclusion Criteria:

• Fixed orthodontic treatment in one dental arch

• Extraction cases

• Patient treated with orthognathic surgery

• Imperfect treatment result due to treatment cessation on patients demand or health issues

• Craniofacial disorders

Related Conditions & MeSH terms

• Malocclusion

Intervention

Diagnostic Test:
• Intraoral scan
On the day of debonding, directly following retainer bonding, intraoral scans were performed (T0), using 3Shape Trios 4 (3Shape, Copenhagen, Denmark). The scans were repeated after a month. The patients were invited for repeating the scans after 1 (T1), 3 (T2) and 6 months (T3).

Locations

Country	Name	City	State
Poland	Department of Interdisciplinary Dentistry, Pomeranian Medical Univeristy in Szczecin	Szczecin	Zachodniopomorskie

Sponsors (3)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin	3Shape Poland Sp.z.o.o., Koszalin University of Technology

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tooth displacement in mm	Measurement obtained by comparing superimposed scans	One month after debonding
Primary	Tooth displacement in mm	Measurement obtained by comparing superimposed scans	Three months after debonding
Primary	Tooth displacement in mm	Measurement obtained by comparing superimposed scans	Six months after debonding
Secondary	Failure rate	Registration wherever the retention failure occured	Six months of observation
Secondary	Compliance rate	Registration of patients attending to scheduled visits	Six months of observation