Does Double With Regular Monitoring Prevent Undesired Tooth Movement?

NCT05626335 | Completed DMC

• 1 other identifier: KB-0012/74/10/2020/Z
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion

Keywords

retention; stability; orthodontic treatment; 3D analysis; intraoral scan

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Failure rate

  Six months of observation

• Compliance rate

  Six months of observation

Study Arms (1)

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

Interventions

Intraoral scan 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).

Study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead
• 3Shape Poland Sp.z.o.o.: collaborator
• Koszalin University of Technology: collaborator

Study Sites (1)

Department of Interdisciplinary Dentistry, Pomeranian Medical Univeristy in Szczecin

Szczecin, West Pomeranian Voivodeship, 70-111, Poland

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: January 1, 2021
• Primary Completion: September 9, 2022
• Study Completion: September 9, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)