Does Double With Regular Monitoring Prevent Undesired Tooth Movement?

NCT ID: NCT05626335

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-09-09

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.

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.

Conditions

Malocclusion

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Intraoral scan

Intervention Type: DIAGNOSTIC_TEST

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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3Shape Poland Sp.z.o.o.

UNKNOWN

Sponsor Role: collaborator

Koszalin University of Technology

UNKNOWN

Sponsor Role: collaborator

Pomeranian Medical University Szczecin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Interdisciplinary Dentistry, Pomeranian Medical Univeristy in Szczecin

Szczecin, West Pomeranian Voivodeship, Poland

Countries

Poland

Other Identifiers

KB-0012/74/10/2020/Z

Identifier Type: -

Identifier Source: org_study_id