Orthodontic Appliance ComplicationNCT04616755
Stability of Maxillary Anterior Teeth After Two Years of Retention in Adolescents Comparing Two Bonded and a Vacuum-formed Retainer
A study testing Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place. in people with Orthodontic Appliance Complication, run by Kronoberg County Council.
Trial summary
After orthodontic treatment 3 different retention devices will be compared.Thirty patients in each group; Group 1) Bonded retainer 13-23, Group 2)Bonded retainer 12-22 and Group 3) Vacuum-formed retainer covering all erupted teeth in the maxilla. Read more about this study
- Who is it for?
- Ages 11 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Aug 2020
- Phase
- Interventional
- 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 11 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Young children age between 11 to 19 years old undergone orthodontic treatment.
Who cannot join
- Syndrome patients
- Skeletal discrepancy
- missing maxillary anterior teeth
- Adults
About this study
Official title: Stability of Maxillary Anterior Teeth After Two Years of Retention in Adolescents - A Randomized Controlled Trial Comparing Two Bonded and a Vacuum-formed Retainer
After orthodontic treatment 3 different retention devices will be compared.Thirty patients in each group; Group 1) Bonded retainer 13-23, Group 2)Bonded retainer 12-22 and Group 3) Vacuum-formed retainer covering all erupted teeth in the maxilla. Retention capacity between these three devices will be compared after 2 years of retention by measuring Contact Point displacements (CPD) between 6 anterior teeth and sum of 5 anterior CPDs called Little´s Irregularity Index (LII).
Read the detailed description
Studies have shown that esthetics, no doubt, is the major motivating factor for orthodontic treatment both in adults and adolescents.Orthodontic relapses are usually described as changes toward the pretreatment status. These changes occur very fast if the teeth are not kept in their new position. That is the reason why, after orthodontic treatment, the result must be stabilized by some kind of retention device to prevent relapse. However, after this first period of remodeling of periodontal structures, comes the later period of changes.
Relapse in aesthetic zone (Anterior teeth), is the major reason why patients are dissatisfied with the results and seek for retreatment. There is a gap in our knowledge which kind of retention device is more effective to stabilize achieved alignment after orthodontic treatment.
This randomized clinical trial, tries to answer to that question. The investigators shall compare three different retention devices and measure changes after 2 years when retention devices have been in place and later compare the long-term results when the retainers have been removed after 2 years of retention (future study 5 years ptstretention).
Randomization Three months before the estimated removal of the fixed appliances, the patients will be invited to take part in the trial. After gaining informed consent from the patient and their custodians, the patients are randomly allocated to one of the three retention groups as follow: A) bonded retainer 13-23, B) bonded retainer 12-22 and C) removable vacuum-formed retainer (VFR) covering the maxillary teeth including the second molars. The randomization process is prepared by an independent person and carried out by three staff members not involved in the trial. The randomization uses blocks of 30. The randomization notes is delivered in a sealed opaque envelope each. Every new participant picked an envelope and reveal the group assignment by opening the envelope. Recruitment is ongoing until the total number of participants meet the estimated sample size.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.
- Keywords
- Retention devices, Relapse, Maxillary incisors, Irregularity
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.Other
Also called Measuring changes of 5 single Contact point displacements in mm 2 years after retention have been I place.
Measuring changes occurred under 2 years which the retention devices have been in place between the groups
| Study group | Role | What they receive |
|---|---|---|
| Bonded retainer 13-23 | Active comparator | This group have bonded retainer behind six front teeth in the maxilla to keep front teeth stable. Receives: Other: Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place. |
| Bonded retainer 12-22 | Active comparator | This group have bonded retainer behind four front teeth in the maxilla to keep front teeth stable. Receives: Other: Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place. |
| Vacuum-formed retainer | Active comparator | This group have Vacuum-formed retainer covering all erupted teeth in maxilla to keep front teeth stable Receives: Other: Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in LII (sum of 5 contact point discrepancy)among 6 maxillary front teeth
Sum of five single contact points of maxillary anterior teeth
Measured: 2 years after retention device in place
Changes in CPD
Changes in single contact point discrepancy of five maxillary anterior teeth
Measured: 2 years after retention device in place
Secondary outcomes (2)
Intercanine distance
Measuring the distance between top of the canines in maxilla
Measured: 2 years after retention device in place
Intermolar distance
Measuring the distance between cusp tips of first molars
Measured: 2 years after retention device in place
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study startApr 2013
- Primary completionAug 2018
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups with different retention devices
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kronoberg County Council
- Sponsor type
- Other government
- Collaborators
- Malmö University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616755
- Sponsor's protocol ID
- Region Kronoberg
- Status last verified
- Nov 2020
- First submitted
- 23 Oct 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naraghi S, Ganzer N, Bondemark L, Sonesson M. Stability of maxillary anterior teeth during retention and 1 year after removal of retention-an RCT on adolescents retained with two different bonded retainers and a vacuum-formed retainer. Eur J Orthod. 2023 Nov 30;45(6):629-636. doi: 10.1093/ejo/cjad020.
PubMed 37119264Sonesson M, Naraghi S, Bondemark L. Cost analysis of two types of fixed maxillary retainers and a removable vacuum-formed maxillary retainer: a randomized controlled trial. Eur J Orthod. 2022 Mar 30;44(2):197-202. doi: 10.1093/ejo/cjab080.
PubMed 35021204Naraghi S, Ganzer N, Bondemark L, Sonesson M. Stability of maxillary anterior teeth after 2 years of retention in adolescents: a randomized controlled trial comparing two bonded and a vacuum-formed retainer. Eur J Orthod. 2021 Apr 3;43(2):152-158. doi: 10.1093/ejo/cjaa077.
PubMed 33351886
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stability of Maxillary Anterior Teeth After Two Years of Retention in Adolescents - A Randomized Controlled Trial Comparing Two Bonded and a Vacuum-formed Retainer
- ClinicalTrials.gov ID
- NCT04616755
- Acronym / sponsor ID
- Region Kronoberg
- Conditions
- Orthodontic Appliance Complication
- Keywords
- Retention devices, Relapse, Maxillary incisors, Irregularity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kronoberg County CouncilOther government
- Collaborators
- Malmö University
- Study start
- Apr 2013 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 5 Nov 2020 (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.
After orthodontic treatment 3 different retention devices will be compared.Thirty patients in each group; Group 1) Bonded retainer 13-23, Group 2)Bonded retainer 12-22 and Group 3) Vacuum-formed retainer covering all erupted teeth in the maxilla. Retention capacity between these three devices will be compared after 2 years of retention by measuring Contact Point displacements (CPD) between 6 anterior teeth and sum of 5 anterior CPDs called Little´s Irregularity Index (LII).
Detailed description
Studies have shown that esthetics, no doubt, is the major motivating factor for orthodontic treatment both in adults and adolescents.Orthodontic relapses are usually described as changes toward the pretreatment status. These changes occur very fast if the teeth are not kept in their new position. That is the reason why, after orthodontic treatment, the result must be stabilized by some kind of retention device to prevent relapse. However, after this first period of remodeling of periodontal structures, comes the later period of changes.
Relapse in aesthetic zone (Anterior teeth), is the major reason why patients are dissatisfied with the results and seek for retreatment. There is a gap in our knowledge which kind of retention device is more effective to stabilize achieved alignment after orthodontic treatment.
This randomized clinical trial, tries to answer to that question. The investigators shall compare three different retention devices and measure changes after 2 years when retention devices have been in place and later compare the long-term results when the retainers have been removed after 2 years of retention (future study 5 years ptstretention).
Randomization Three months before the estimated removal of the fixed appliances, the patients will be invited to take part in the trial. After gaining informed consent from the patient and their custodians, the patients are randomly allocated to one of the three retention groups as follow: A) bonded retainer 13-23, B) bonded retainer 12-22 and C) removable vacuum-formed retainer (VFR) covering the maxillary teeth including the second molars. The randomization process is prepared by an independent person and carried out by three staff members not involved in the trial. The randomization uses blocks of 30. The randomization notes is delivered in a sealed opaque envelope each. Every new participant picked an envelope and reveal the group assignment by opening the envelope. Recruitment is ongoing until the total number of participants meet the estimated sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups with different retention devices
| Arm | Type | Receives |
|---|---|---|
| Bonded retainer 13-23 | Active comparator | Other: Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.This group have bonded retainer behind six front teeth in the maxilla to keep front teeth stable. |
| Bonded retainer 12-22 | Active comparator | Other: Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.This group have bonded retainer behind four front teeth in the maxilla to keep front teeth stable. |
| Vacuum-formed retainer | Active comparator | Other: Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.This group have Vacuum-formed retainer covering all erupted teeth in maxilla to keep front teeth stable |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Young children age between 11 to 19 years old undergone orthodontic treatment.
Key exclusion criteria (4 listed)
- Syndrome patients
- Skeletal discrepancy
- missing maxillary anterior teeth
- Adults
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 |
|---|---|---|
| Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.Also: Measuring changes of 5 single Contact point displacements in mm 2 years after retention have been I place.Measuring changes occurred under 2 years which the retention devices have been in place between the groups | Other | Bonded retainer 12-22, Bonded retainer 13-23, Vacuum-formed retainer |
Primary outcome
Changes in LII (sum of 5 contact point discrepancy)among 6 maxillary front teeth
Time frame: 2 years after retention device in place
Sum of five single contact points of maxillary anterior teeth
Changes in CPD
Time frame: 2 years after retention device in place
Changes in single contact point discrepancy of five maxillary anterior teeth
2 secondary outcomes
Intercanine distance
Time frame: 2 years after retention device in place
Intermolar distance
Time frame: 2 years after retention device in place
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 13 Nov 2020.
- Derived from this study: PubMed 37119264Naraghi S, Ganzer N, Bondemark L, Sonesson M. Stability of maxillary anterior teeth during retention and 1 year after removal of retention-an RCT on adolescents retained with two different bonded retainers and a vacuum-formed retainer. Eur J Orthod. 2023 Nov 30;45(6):629-636. doi: 10.1093/ejo/cjad020.
- Derived from this study: PubMed 35021204Sonesson M, Naraghi S, Bondemark L. Cost analysis of two types of fixed maxillary retainers and a removable vacuum-formed maxillary retainer: a randomized controlled trial. Eur J Orthod. 2022 Mar 30;44(2):197-202. doi: 10.1093/ejo/cjab080.
- Derived from this study: PubMed 33351886Naraghi S, Ganzer N, Bondemark L, Sonesson M. Stability of maxillary anterior teeth after 2 years of retention in adolescents: a randomized controlled trial comparing two bonded and a vacuum-formed retainer. Eur J Orthod. 2021 Apr 3;43(2):152-158. doi: 10.1093/ejo/cjaa077.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place. in people with Orthodontic Appliance Complication, run by Kronoberg County Council.
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 1 inclusion and 4 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Changes in LII (sum of 5 contact point discrepancy)among 6 maxillary front teeth (time frame: 2 years after retention device in place). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04616755, which also lists 3 linked publications.
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 13 Nov 2020.