Orthodontic RelapseorthoretentiNCT05121220
Efficacy and Cost-effectiveness of Orthodontic Retention Protocols
A study testing fixed retainer and removable retainer in people with Orthodontic Relapse, run by Poliklinika Orthonova at 1 site in Croatia.
Trial summary
Objective is to assess changes of dentition and periodontium, and hygiene in retention after the end of the active phase of orthodontic treatment, and relationship with gender, type of retention appliance, pre-therapeutic condition of dentition and duration of active phase of treatment. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Relapse
- What is being tested?
- fixed retainer and removable retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteCroatia
- Study dates
- 15 Nov 2020to 15 Nov 2023
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria: finished orthodontic treatment, participants must have all permanent teeth Exclusion Criteria: hypodontia, missing teeth
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Poliklinika Orthonova
Zagreb, 10000
Silvija Kanižaj Ugrin, DMD, +385915232860, kanizaj.ugrin@gmail.com
About this study
Objective is to assess changes of dentition and periodontium, and hygiene in retention after the end of the active phase of orthodontic treatment, and relationship with gender, type of retention appliance, pre-therapeutic condition of dentition and duration of active phase of treatment.
Read the detailed description
A total of 152 subjects will be recruited and randomly assigned into three groups. First group will have a square 8-stranded 0.673x0.268 mm retainer wire bonded in mandibular teeth after completing the active phase of comprehensive orthodontic treatment with fixed appliances. Retainer will be bonded on lingual site canine to canine on each tooth. Second group will have a round 6-stranded 0.40 mm retainer in mandible. Third group will be without fixed retainer, only with thermoplastic vacuum-formed removable Essix retainer in mandible.
Subjects will be examined before orthodontic treatment (T0), upon completion of treatment (T1), six months in retention (T2), two years (T3) and three years in retention (T4). Changes in intercanine width, relapse (unexpected tooth movements), retainer failure, accumulation of biofilm, calculus and gingivitis will be assessed.
- Conditions
- Orthodontic Relapse
- Being tested
- fixed retainer, removable retainer
- Keywords
- retention wire, fixed retainer, orthodontic therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixed retainerDevice
bonded lingual mandibular fixed retainer on frontal teeth 33-43
removable retainerDevice
thermoplastic vacuum-formed removable mandibular retainer
| Study group | Role | What they receive |
|---|---|---|
| fixed mandibular lingual rectangular retainer 0.673 x 0.268 mm | Experimental | 0.673 x 0.268 mm 8-stranded wire Bond A Braid (Reliance Orthodontic Products, USA) will be bonded in mandible canine to canine on each tooth using Filtek flowable composite (Ivoclar Vivadent, Lichtenstein) and Multilink adhesive (3M, USA). Receives: Device: fixed retainer |
| fixed mandibular lingual round retainer 0.40 mm | Experimental | 0.40 mm round 6-stranded wire (Forestadent, Germany) will be bonded on 6 mandibular frontal teeth, canine to canine on each tooth using Filtek flowable composite (Ivoclar Vivadent, Lichtenstein) and Multilink adhesive (3M, USA). Receives: Device: fixed retainer |
| removable mandibular retainer | Active comparator | Group without fixed retainer will be wearing removable thermoplastic vacuum-formed Essix retainer Receives: Device: removable retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of relapse (unexpected tooth movement in mandibular frontal area) at 1 year
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
Measured: 1 year
severity of relapse (unexpected tooth movement in mandibular frontal area) at 2 years
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
Measured: 2 years
severity of relapse (unexpected tooth movement in mandibular frontal area) at 3 years
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
Measured: 3 years
incidence of retainer failure (debonding, breakage) at 2 years
percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
Measured: 2 years
incidence of retainer failure (debonding, breakage) at 3 years
percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
Measured: 3 years
extent of biofilm accumulation at 2 years
the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result
Measured: 2 years
extent of biofilm accumulation at 3 years
the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result
Measured: 3 years
Secondary outcomes (4)
incidence of intercanine width change
percentage of cases with intercanine width change, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
Measured: 3 years
changes of intercanine width
the unabbreviated scale title: intercanine width change in millimeters, the minimum and maximum values 0,5, higher scores mean a worse outcome, lower result mean a better outcome
Measured: 2 years, 3 years
extent of calculus accumulation at 2 years
the unabbreviated scale title: Calculus Surface Index (CSI)-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome
Measured: 2 years
extent of calculus accumulation at 3 years
the unabbreviated scale title: Calculus Surface Index (CSI)-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start15 Nov 2020
- Primary completion15 Nov 2022 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthodontic RelapseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poliklinika Orthonova
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zagreb, University of Rijeka
- Responsible party
- Principal investigator, silvija kanižaj ugrin, Poliklinika Orthonova
- Investigators
- Silvija Kanižaj Ugrin, DDM, Principal investigator, Poliklinika Orthonova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121220
- Sponsor's protocol ID
- 66771011
- Acronym
- orthoretenti
- Status last verified
- May 2022
- First submitted
- 2 Oct 2021
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: on request
Publications
Kanizaj Ugrin S, Kiseri Kubati J, Cirgic E, Simeon P, Spalj S. Stability, survival and costs of vacuum-formed retainers versus bonded lingual braided rectangular and multistranded round wire retainers in the mandible of orthodontic patients over a two-year period. BMC Oral Health. 2025 Nov 14;25(1):1782. doi: 10.1186/s12903-025-07174-w.
PubMed 41239352Kanizaj Ugrin S, Spalj S. Comparison of efficacy of thermoplastic retainer with round and rectangular bonded lingual wire retainer in the mandible two years after orthodontic treatment: a randomised controlled trial. Clin Oral Investig. 2024 Mar 1;28(3):183. doi: 10.1007/s00784-024-05572-y.
PubMed 38424224
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cost-effectiveness of Orthodontic Retention Protocols
- ClinicalTrials.gov ID
- NCT05121220
- Acronym / sponsor ID
- orthoretenti / 66771011
- Conditions
- Orthodontic Relapse
- Keywords
- retention wire, fixed retainer, orthodontic therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Poliklinika OrthonovaUniversity, hospital or other
- Collaborators
- University of Zagreb, University of Rijeka
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 16 Nov 2021 (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.
Objective is to assess changes of dentition and periodontium, and hygiene in retention after the end of the active phase of orthodontic treatment, and relationship with gender, type of retention appliance, pre-therapeutic condition of dentition and duration of active phase of treatment.
Detailed description
A total of 152 subjects will be recruited and randomly assigned into three groups. First group will have a square 8-stranded 0.673x0.268 mm retainer wire bonded in mandibular teeth after completing the active phase of comprehensive orthodontic treatment with fixed appliances. Retainer will be bonded on lingual site canine to canine on each tooth. Second group will have a round 6-stranded 0.40 mm retainer in mandible. Third group will be without fixed retainer, only with thermoplastic vacuum-formed removable Essix retainer in mandible.
Subjects will be examined before orthodontic treatment (T0), upon completion of treatment (T1), six months in retention (T2), two years (T3) and three years in retention (T4). Changes in intercanine width, relapse (unexpected tooth movements), retainer failure, accumulation of biofilm, calculus and gingivitis will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fixed mandibular lingual rectangular retainer 0.673 x 0.268 mm | Experimental | Device: fixed retainer0.673 x 0.268 mm 8-stranded wire Bond A Braid (Reliance Orthodontic Products, USA) will be bonded in mandible canine to canine on each tooth using Filtek flowable composite (Ivoclar Vivadent, Lichtenstein) and Multilink adhesive (3M, USA). |
| fixed mandibular lingual round retainer 0.40 mm | Experimental | Device: fixed retainer0.40 mm round 6-stranded wire (Forestadent, Germany) will be bonded on 6 mandibular frontal teeth, canine to canine on each tooth using Filtek flowable composite (Ivoclar Vivadent, Lichtenstein) and Multilink adhesive (3M, USA). |
| removable mandibular retainer | Active comparator | Device: removable retainerGroup without fixed retainer will be wearing removable thermoplastic vacuum-formed Essix retainer |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| fixed retainerbonded lingual mandibular fixed retainer on frontal teeth 33-43 | Device | fixed mandibular lingual rectangular retainer 0.673 x 0.268 mm, fixed mandibular lingual round retainer 0.40 mm |
| removable retainerthermoplastic vacuum-formed removable mandibular retainer | Device | removable mandibular retainer |
Primary outcome
severity of relapse (unexpected tooth movement in mandibular frontal area) at 1 year
Time frame: 1 year
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
severity of relapse (unexpected tooth movement in mandibular frontal area) at 2 years
Time frame: 2 years
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
severity of relapse (unexpected tooth movement in mandibular frontal area) at 3 years
Time frame: 3 years
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
incidence of retainer failure (debonding, breakage) at 2 years
Time frame: 2 years
percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
incidence of retainer failure (debonding, breakage) at 3 years
Time frame: 3 years
percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
extent of biofilm accumulation at 2 years
Time frame: 2 years
the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result
extent of biofilm accumulation at 3 years
Time frame: 3 years
the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result
4 secondary outcomes
incidence of intercanine width change
Time frame: 3 years
changes of intercanine width
Time frame: 2 years, 3 years
extent of calculus accumulation at 2 years
Time frame: 2 years
extent of calculus accumulation at 3 years
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Derived from this study: PubMed 41239352Kanizaj Ugrin S, Kiseri Kubati J, Cirgic E, Simeon P, Spalj S. Stability, survival and costs of vacuum-formed retainers versus bonded lingual braided rectangular and multistranded round wire retainers in the mandible of orthodontic patients over a two-year period. BMC Oral Health. 2025 Nov 14;25(1):1782. doi: 10.1186/s12903-025-07174-w.
- Derived from this study: PubMed 38424224Kanizaj Ugrin S, Spalj S. Comparison of efficacy of thermoplastic retainer with round and rectangular bonded lingual wire retainer in the mandible two years after orthodontic treatment: a randomised controlled trial. Clin Oral Investig. 2024 Mar 1;28(3):183. doi: 10.1007/s00784-024-05572-y.
- Individual participant dataSharing planned: No. on request
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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.
Silvija Kanižaj Ugrin, DDM principal investigator
Poliklinika Orthonova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fixed retainer and removable retainer in people with Orthodontic Relapse, run by Poliklinika Orthonova at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 9 May 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 Croatia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvija Kanižaj Ugrin, DDM (00385915232860, kanizaj.ugrin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
severity of relapse (unexpected tooth movement in mandibular frontal area) at 1 year (time frame: 1 year). The study lists 7 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 NCT05121220, which also lists 2 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 9 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.