RelapseNCT05250765
Comparison of Efficiency and Effectiveness of Two Types of Bonded Orthodontic Retainers: an RCT.
A study testing Twistflex retainer and Orthoflex retainer in people with Relapse, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Comparson of efficiency and effectiveness of twisted/coaxial and linked retainers, placed under relative versus absolute isolation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Relapse
- What is being tested?
- Twistflex retainer and Orthoflex retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2020to 1 Sep 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Fixed orthodontic appliances upper and lower jaw
- Patient stays for 2 years in Belgium
- Parents consent
- Proper oral hygiene
Who cannot join
- Orthognathic surgery
- Craniofacial disorders
- Cleft lip palate patients
- Orthodontic treatment without fixed appliances
- Extra retention other than bonded wire in the lower jaw
Trial locations and contacts
1 site in 1 country.
About this study
Comparson of efficiency and effectiveness of twisted/coaxial and linked retainers, placed under relative versus absolute isolation.
Read the detailed description
The domain of orthodontic retention is controversial. Orthodontic retention is the final step in an orthodontic procedure, and is performed after removal of the orthodontic appliance. Its goal is to prevent the relapse in occlusion or positioning of the teeth. Every patient will need some form of retention to maintain the ideal result. The bonded retainer is frequently used in the lower incisor region. It is capable to prevent relapse of orthodontic treatment but prevents tertiary crowding as well. Advantages of fixed retainers are in general no need for compliance and optimal aesthetics. The retention wire can stay in place for many years. Currently, there is a tendency towards lifelong retention. Disadvantages are more plaque and calculus accumulation, and possibly a poorer periodontal index.
Many types of bonded retainers with different properties could be bonded, each with different effects on periodontal health, potentially a different ability to maintain alignment, and different amounts of failure.
Different types of failure of fixed bonded retainers are possible. When the retainer does not stay in place and is debonded, this is is described as failure. It is also possible the retainer maintains bonded but shows unwanted tooth movement in the bonded teeth. This can also be described as a failure.
Bonding of the retention wire is a technique sensitive process. Correct and passive bonding could prevent debonding of the retainers. To eliminate moisture in the bonding process, it is possible to place a rubberdam before bonding the retainer.
One aim of this study is to compare two types of bonded retainer: the standard coaxial or twisted retainer. The other aim is to compare two bonding protocols with and without rubberdam isolation
Two general PICO questions can be formulated:
In an orthodontic patient (P), will fixed retention with a Ortho-flextech tm (Reliance orthodontic products, Itasca III, USA) (I) as compared to a 0.0195 in dead-soft coaxial wire (Respond; Ormco, Orange, Calif). (C) result in a more effective or efficient retention treatment (O)?
In an orthodontic patient (P), will placement of the retainer with rubber dam (I) result in less debonding (O) as compared to relative isolation with cotton rolls (C)?
Efficiency: is the procedure faster or cheaper than the alternative? Effectiveness: is the procedure better in maintaining the end result of treatment than the alternative? Are there less biomechanical or biological side effects?
- Conditions
- Relapse
- Being tested
- Twistflex retainer, Orthoflex retainer
- Keywords
- Orthodontic retainers, Isolation, Bonding, Twistflex retainer, Coaxial retainer, OrthoflexTech retainer, Fixed retainer
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twistflex retainerDevice
twisted 0.0195 dead-soft coaxial wire (Respond; Ormco, Orange, Calif)
Orthoflex retainerDevice
Ortho-flextech (Reliance orthodontic products, Itasca III, USA)
| Study group | Role | What they receive |
|---|---|---|
| Bonding with rubberdam | Experimental | The retainer is bonded under rubber dam isolation Receives: Device: Twistflex retainer; Device: Orthoflex retainer |
| Bonding under relative isolation | Active comparator | The retainer is bonded under relative isolation (hygrophormic suction, cotton pads) Receives: Device: Twistflex retainer; Device: Orthoflex retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Little Irregularity index
Stability of treatment. The index measures the distance, in millimetres, between the contact points of crooked teeth, and then adds them together. Therefore,the Irregularity Index is the sum of all the displaced contacts between the anterior teeth (canine to canine)
Measured: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Secondary outcomes (5)
Failure of the retainer (1)
Debonding of the retainer is registered, the date and place of reparation.
Measured: Through study completion (2 years)
Failure of the retainer (2)
Possible activation (unwanted tooth movement possible torque differences) is checked after treatment.
Measured: Through study completion (2 years)
Periodontal index- periodontal status
A periodontal status of the 6 anterior teeth is made, measuring probing depth 6 places per teeth
Measured: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Periodontal index- BoP
Bleeding on probing is registered after the periodontal status (%)
Measured: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Periodontal index- plaque
Plaque measurement (%)
Measured: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start1 Sep 2020
- Primary completion1 Dec 2022
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for RelapseStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- 4 study groups are possible (2 types of retainers and 2 types of bonding protocol)
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy De Pauw, Prof, Study chair, Head of orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250765
- Sponsor's protocol ID
- BC-08508
- Status last verified
- Dec 2023
- First submitted
- 11 Jan 2022
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stormann I, Ehmer U. A prospective randomized study of different retainer types. J Orofac Orthop. 2002 Jan;63(1):42-50. doi: 10.1007/s00056-002-0040-6. English, German.
PubMed 11974451Engeler OG, Dalstra M, Arnold DT, Steineck M, Verna C. In vitro comparison of the torsional load transfer of various commercially available stainless-steel wires used for fixed retainers in orthodontics. J Orthod. 2021 Jun;48(2):118-126. doi: 10.1177/1465312520972402. Epub 2020 Nov 24.
PubMed 33231109Ferreira LA, Sapata DM, Provenzano MGA, Hayacibara RM, Ramos AL. Periodontal parameters of two types of 3 x 3 orthodontic retainer: a longitudinal study. Dental Press J Orthod. 2019 Aug 1;24(3):64-70. doi: 10.1590/2177-6709.24.3.064-070.oar.
PubMed 31390451Sifakakis I, Eliades T, Bourauel C. Residual stress analysis of fixed retainer wires after in vitro loading: can mastication-induced stresses produce an unfavorable effect? Biomed Tech (Berl). 2015 Dec;60(6):617-22. doi: 10.1515/bmt-2015-0013.
PubMed 26057215Liebenberg WH. Extending the use of rubber dam isolation: alternative procedures. Part II. Quintessence Int. 1993 Jan;24(1):7-17.
PubMed 8511260Arnold DT, Dalstra M, Verna C. Torque resistance of different stainless steel wires commonly used for fixed retainers in orthodontics. J Orthod. 2016 Jun;43(2):121-9. doi: 10.1080/14653125.2016.1155814. Epub 2016 Apr 22.
PubMed 27104351Arnone R. Bonding orthodontic lower 3 to 3 retainers with a rubber dam: a second generation step-by-step procedure. Am J Orthod Dentofacial Orthop. 1999 Oct;116(4):432-4. doi: 10.1016/s0889-5406(99)70229-5.
PubMed 10511672Aldrees AM, Al-Mutairi TK, Hakami ZW, Al-Malki MM. Bonded orthodontic retainers: a comparison of initial bond strength of different wire-and-composite combinations. J Orofac Orthop. 2010 Jul;71(4):290-9. doi: 10.1007/s00056-010-9947-5. Epub 2010 Jul 30. English, German.
PubMed 20676816
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficiency and Effectiveness of Two Types of Bonded Orthodontic Retainers: an RCT.
- ClinicalTrials.gov ID
- NCT05250765
- Acronym / sponsor ID
- BC-08508
- Conditions
- Relapse
- Keywords
- Orthodontic retainers, Isolation, Bonding, Twistflex retainer, Coaxial retainer, OrthoflexTech retainer, Fixed retainer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 22 Feb 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.
Comparson of efficiency and effectiveness of twisted/coaxial and linked retainers, placed under relative versus absolute isolation.
Detailed description
The domain of orthodontic retention is controversial. Orthodontic retention is the final step in an orthodontic procedure, and is performed after removal of the orthodontic appliance. Its goal is to prevent the relapse in occlusion or positioning of the teeth. Every patient will need some form of retention to maintain the ideal result. The bonded retainer is frequently used in the lower incisor region. It is capable to prevent relapse of orthodontic treatment but prevents tertiary crowding as well. Advantages of fixed retainers are in general no need for compliance and optimal aesthetics. The retention wire can stay in place for many years. Currently, there is a tendency towards lifelong retention. Disadvantages are more plaque and calculus accumulation, and possibly a poorer periodontal index.
Many types of bonded retainers with different properties could be bonded, each with different effects on periodontal health, potentially a different ability to maintain alignment, and different amounts of failure.
Different types of failure of fixed bonded retainers are possible. When the retainer does not stay in place and is debonded, this is is described as failure. It is also possible the retainer maintains bonded but shows unwanted tooth movement in the bonded teeth. This can also be described as a failure.
Bonding of the retention wire is a technique sensitive process. Correct and passive bonding could prevent debonding of the retainers. To eliminate moisture in the bonding process, it is possible to place a rubberdam before bonding the retainer.
One aim of this study is to compare two types of bonded retainer: the standard coaxial or twisted retainer. The other aim is to compare two bonding protocols with and without rubberdam isolation
Two general PICO questions can be formulated:
In an orthodontic patient (P), will fixed retention with a Ortho-flextech tm (Reliance orthodontic products, Itasca III, USA) (I) as compared to a 0.0195 in dead-soft coaxial wire (Respond; Ormco, Orange, Calif). (C) result in a more effective or efficient retention treatment (O)?
In an orthodontic patient (P), will placement of the retainer with rubber dam (I) result in less debonding (O) as compared to relative isolation with cotton rolls (C)?
Efficiency: is the procedure faster or cheaper than the alternative? Effectiveness: is the procedure better in maintaining the end result of treatment than the alternative? Are there less biomechanical or biological side effects?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 4 study groups are possible (2 types of retainers and 2 types of bonding protocol)
| Arm | Type | Receives |
|---|---|---|
| Bonding with rubberdam | Experimental | Device: Twistflex retainer, Device: Orthoflex retainerThe retainer is bonded under rubber dam isolation |
| Bonding under relative isolation | Active comparator | Device: Twistflex retainer, Device: Orthoflex retainerThe retainer is bonded under relative isolation (hygrophormic suction, cotton pads) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Fixed orthodontic appliances upper and lower jaw
- Patient stays for 2 years in Belgium
- Parents consent
- Proper oral hygiene
Key exclusion criteria (5 listed)
- Orthognathic surgery
- Craniofacial disorders
- Cleft lip palate patients
- Orthodontic treatment without fixed appliances
- Extra retention other than bonded wire in the lower jaw
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 |
|---|---|---|
| Twistflex retainertwisted 0.0195 dead-soft coaxial wire (Respond; Ormco, Orange, Calif) | Device | Bonding under relative isolation, Bonding with rubberdam |
| Orthoflex retainerOrtho-flextech (Reliance orthodontic products, Itasca III, USA) | Device | Bonding under relative isolation, Bonding with rubberdam |
Primary outcome
Little Irregularity index
Time frame: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Stability of treatment. The index measures the distance, in millimetres, between the contact points of crooked teeth, and then adds them together. Therefore,the Irregularity Index is the sum of all the displaced contacts between the anterior teeth (canine to canine)
5 secondary outcomes
Failure of the retainer (1)
Time frame: Through study completion (2 years)
Failure of the retainer (2)
Time frame: Through study completion (2 years)
Periodontal index- periodontal status
Time frame: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Periodontal index- BoP
Time frame: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
Periodontal index- plaque
Time frame: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)
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 Dec 2023.
- Background: PubMed 11974451Stormann I, Ehmer U. A prospective randomized study of different retainer types. J Orofac Orthop. 2002 Jan;63(1):42-50. doi: 10.1007/s00056-002-0040-6. English, German.
- Background: PubMed 33231109Engeler OG, Dalstra M, Arnold DT, Steineck M, Verna C. In vitro comparison of the torsional load transfer of various commercially available stainless-steel wires used for fixed retainers in orthodontics. J Orthod. 2021 Jun;48(2):118-126. doi: 10.1177/1465312520972402. Epub 2020 Nov 24.
- Background: PubMed 31390451Ferreira LA, Sapata DM, Provenzano MGA, Hayacibara RM, Ramos AL. Periodontal parameters of two types of 3 x 3 orthodontic retainer: a longitudinal study. Dental Press J Orthod. 2019 Aug 1;24(3):64-70. doi: 10.1590/2177-6709.24.3.064-070.oar.
- Background: PubMed 26057215Sifakakis I, Eliades T, Bourauel C. Residual stress analysis of fixed retainer wires after in vitro loading: can mastication-induced stresses produce an unfavorable effect? Biomed Tech (Berl). 2015 Dec;60(6):617-22. doi: 10.1515/bmt-2015-0013.
- Background: PubMed 8511260Liebenberg WH. Extending the use of rubber dam isolation: alternative procedures. Part II. Quintessence Int. 1993 Jan;24(1):7-17.
- Background: PubMed 27104351Arnold DT, Dalstra M, Verna C. Torque resistance of different stainless steel wires commonly used for fixed retainers in orthodontics. J Orthod. 2016 Jun;43(2):121-9. doi: 10.1080/14653125.2016.1155814. Epub 2016 Apr 22.
- Background: PubMed 10511672Arnone R. Bonding orthodontic lower 3 to 3 retainers with a rubber dam: a second generation step-by-step procedure. Am J Orthod Dentofacial Orthop. 1999 Oct;116(4):432-4. doi: 10.1016/s0889-5406(99)70229-5.
- Background: PubMed 20676816Aldrees AM, Al-Mutairi TK, Hakami ZW, Al-Malki MM. Bonded orthodontic retainers: a comparison of initial bond strength of different wire-and-composite combinations. J Orofac Orthop. 2010 Jul;71(4):290-9. doi: 10.1007/s00056-010-9947-5. Epub 2010 Jul 30. English, German.
- 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.
Guy De Pauw, Prof study chair
Head of orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Twistflex retainer and Orthoflex retainer in people with Relapse, run by University Hospital, Ghent at 1 site in Belgium.
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 4 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 13 Dec 2023. 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 Belgium. 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?
Little Irregularity index (time frame: Measured before removing braces (T0), after 6 months (T1), 1 year (T2) and 2 years (T3)). 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 NCT05250765, which also lists 8 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 Dec 2023.