Does Double With Regular Monitoring Prevent Undesired Tooth Movement?

Sponsor

Pomeranian Medical University Szczecin (Other)

Overall Status

Completed

CT.gov ID

NCT05626335

Collaborator

3Shape Poland Sp.z.o.o. (Other), Koszalin University of Technology (Other)

100

Enrollment

Location

20.2

Actual Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Malocclusion	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 Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Sep 9, 2022

Actual Study Completion Date :

Sep 9, 2022

Arms and Interventions

Arm	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).

Arm

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).

Outcome Measures

Primary Outcome Measures

Tooth displacement in mm [One month after debonding]
Measurement obtained by comparing superimposed scans
Tooth displacement in mm [Three months after debonding]
Measurement obtained by comparing superimposed scans
Tooth displacement in mm [Six months after debonding]
Measurement obtained by comparing superimposed scans

Secondary Outcome Measures

Failure rate [Six months of observation]
Registration wherever the retention failure occured
Compliance rate [Six months of observation]
Registration of patients attending to scheduled visits

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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