Does Double With Regular Monitoring Prevent Undesired Tooth Movement?

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

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

Study Overview

• Status: Completed
• Conditions: Malocclusion
• Intervention / Treatment: Diagnostic test: Intraoral scan

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Poland
  • Zachodniopomorskie
    • Szczecin, Zachodniopomorskie, Poland, 70-111
      • Department of Interdisciplinary Dentistry, Pomeranian Medical Univeristy in Szczecin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study group comprised 300 patients adult patients (age 18 to 41) who have completed fixed orthodontic treatment between (1st January 2021 - 9th September 2022).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Study group; From all the patients meeting the inclusion criteria every third patients was randomly chosen and invited to participate in the study. Written informed consent was obtained from every participant. Thus 100 patients have agreed to participate. All fixed retainers (stainless steel braided rectangular wire) were bonded in both arches by the same experienced clinician, who subsequently made impression for thermally formed splints and delivered them on the day of debonding. The effect of each of the procedures was verified by two independent experienced clinicians. On the day of debonding, directly following retainer bonding, intraoral scans were performed (T0). The patients were invited for repeating the scans after 1 (T1), 3 (T2) and 6 months (T3). The displacements were assessed by superimposition of the scans. The patients were recommended to wear removable retainers 22h/day. They were instructed to immediately report a failure and to apply immediately to the office in case of failure.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tooth displacement in mm	Measurement obtained by comparing superimposed scans	One month after debonding
Tooth displacement in mm	Measurement obtained by comparing superimposed scans	Three months after debonding
Tooth displacement in mm	Measurement obtained by comparing superimposed scans	Six months after debonding

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure rate	Registration wherever the retention failure occured	Six months of observation
Compliance rate	Registration of patients attending to scheduled visits	Six months of observation

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin
• Collaborators: 3Shape Poland Sp.z.o.o.; Koszalin University of Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): September 9, 2022

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: retention; stability; orthodontic treatment; 3D analysis; intraoral scan
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: KB-0012/74/10/2020/Z

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No