MalocclusionNCT05626335
Does Double With Regular Monitoring Prevent Undesired Tooth Movement?
An observational study of Malocclusion, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- Intraoral scan
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2021to 9 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Interdisciplinary Dentistry, Pomeranian Medical Univeristy in Szczecin
Szczecin, West Pomeranian Voivodeship, 70-111
About this study
Official title: 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.
Read the 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
- Being tested
- Intraoral scan
- Keywords
- retention, stability, orthodontic treatment, 3D analysis, intraoral scan
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral scanDiagnostic 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 | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Intraoral scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth displacement in mm
Measurement obtained by comparing superimposed scans
Measured: One month after debonding
Tooth displacement in mm
Measurement obtained by comparing superimposed scans
Measured: Three months after debonding
Tooth displacement in mm
Measurement obtained by comparing superimposed scans
Measured: Six months after debonding
Secondary outcomes (2)
Failure rate
Registration wherever the retention failure occured
Measured: Six months of observation
Compliance rate
Registration of patients attending to scheduled visits
Measured: Six months of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Jan 2021
- Primary completion9 Sep 2022
- Study completion9 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Collaborators
- 3Shape Poland Sp.z.o.o., Koszalin University of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626335
- Sponsor's protocol ID
- KB-0012/74/10/2020/Z
- Status last verified
- Oct 2022
- First submitted
- 15 Nov 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Double (Fixed and Removable Orthodontic Retention) With Regular Monitoring Prevent Undesired Tooth Movement?
- ClinicalTrials.gov ID
- NCT05626335
- Acronym / sponsor ID
- KB-0012/74/10/2020/Z
- Conditions
- Malocclusion
- Keywords
- retention, stability, orthodontic treatment, 3D analysis, intraoral scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Collaborators
- 3Shape Poland Sp.z.o.o., Koszalin University of Technology
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 9 Sep 2022 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Intraoral scanFrom 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoral scanOn 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). | Diagnostic test | Study group |
Primary outcome
Tooth displacement in mm
Time frame: One month after debonding
Measurement obtained by comparing superimposed scans
Tooth displacement in mm
Time frame: Three months after debonding
Measurement obtained by comparing superimposed scans
Tooth displacement in mm
Time frame: Six months after debonding
Measurement obtained by comparing superimposed scans
2 secondary outcomes
Failure rate
Time frame: Six months of observation
Compliance rate
Time frame: Six months of observation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malocclusion, run by Pomeranian Medical University Szczecin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tooth displacement in mm (time frame: One month after debonding). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.