Orthodontic RetainersNCT04237298
Comparison of Modified Vacuum-formed Retainers Versus Hawley Retainer
A study testing Modified vacuum-formed retainer covering the palete in people with Orthodontic Retainers and Clinical Trial, run by National University of Malaysia at 3 sites in Malaysia.
Trial summary
This study will focus on the relapse of arch width in two types of retention regimes, which are modified vacuum-formed retainers and Hawley type retainers in patients after fixed appliance treatment in transverse arch expansion cases. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Retainers, Clinical Trial
- What is being tested?
- Modified vacuum-formed retainer covering the palete
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesMalaysia
- Study dates
- 1 Aug 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who are at least 13 years old at time of debond.
- Treatment plan of extraction or non-extraction followed by straight wire appliances in the upper arch only or both arches
- Undergone more than 3mm of maxillary dentoalveolar expansion. Initially, the amount of arch width expansion was measured intraorally at debond and compared to their respective pre-treatment dental casts. To ensure accuracy, the measurements were repeated on debond and pre-treatment dental casts. The following linear arch width measurements were made: intercanine width (ICW - the distance between the canine cusp tips), interpremolar width (IPMW - the distance between the premolar cusp tips), interfirst molar width 1 (IFMW1 - the distance between the mesiobuccal cusp), and interfirst molar width 2 (IFMW2 - the distance between the distobuccal cusp). At least two or more points were expanded (> 3mm) to be included in the trial.
- No chronic medical conditions
Who cannot join
- -
Trial locations and contacts
3 sites in 1 country.
Malaysia3 sites
Unit Pakar Ortodontik Klinik Pergigian Sungai Chua
Kajang, Selangor, 43000
Klinik Pakar Ortodontik Klinik Kesihatan Bandar Botanik
Klang, Selangor, 42000
Orthodontic Specialist Clinic
Kuala Lumpur, 50300
About this study
Official title: Comparison of Relapse Arch Width in Modified Vacuum Formed Retainers Covering the Palate Versus Hawley Retainer: A Prospective Randomized Control Trial
This study will focus on the relapse of arch width in two types of retention regimes, which are modified vacuum-formed retainers and Hawley type retainers in patients after fixed appliance treatment in transverse arch expansion cases. This will subsequently be of valuable information for clinicians in choosing the appropriate type of retainers after removal of their fixed appliances. This is because the modified vacuum-formed retainers will be significantly cheaper, quicker and easier to fabricate.
Read the detailed description
Relapse is inevitable in orthodontic treatment. Teeth will want to return to their original position after fixed appliances are removed. Regardless with or without fixed appliances, changes and physiological relapse will still occur due to time and age changes. This is why retention is a crucial part of orthodontic treatment, where it would aim to maintain the corrections achieved after orthodontic treatment.
Literature regarding retainers is quite substantial, where a recent Cochrane review was published comparing the different types of retainers. However, the evidence is lacking in terms of comparison of arch width relapse between modified vacuum-formed retainers and Hawley retainers specifically in expansion cases.
This study aims to compare the relapse in arch width in expansion cases with modified vacuum-formed retainers with palatal coverage versus Hawley type retainers in Unit Ortodontik Universiti Kebangsaan Malaysia (UKM), Klinik Pakar Ortodontik Klinik Kesihatan Bandar Botanik and Unit Pakar Ortodontik Klinik Pergigian Sungai Chua patients. Although other types of modified vacuum-formed retainers effective for maintaining palatal expansion have been described, these retainers require a wire outlining the Cementoenamel junction of the teeth palatally. This technique requires the experience of the technician, is at a higher cost and requires more lab time. The modified retainer that investigators described in this study would be as efficient and as quick as the normal vacuum-formed retainers, which would usually take a couple of hours to make (same day or next day fit). The present practice at all 3 locations constructs Hawley and normal VFR retainers for all orthodontic patients. There are technicians and laboratory facilities to construct normal VFR as well as Hawley retainer. The only difference between modified and normal vacuum formed retainer is the outline of the retainers where the technician would trim the retainer, where it would cover the hard palate. Therefore it is only the location of trimming that is different using the same special trimming appliances for normal VFRs.
A number of subjects who fulfil the criteria will be invited to participate in this study. The study will involve arch width analysis using study models pre, post-debond, 3 months review post-debond, and 6 months review post-debond. All data will be analyses using Statistical Package for Social Sciences (SPSS). The arch width of participants post-fixed appliances will be compared. Most studies compare the arch width, as well as lower incisor irregularity in evaluating relapse in different groups of retainers. However, there are currently no randomized control trials comparing expansion cases of Hawley vs vacuum-formed retainers, hence why this study will be conducted.
The investigators expect to see no difference between the modified vacuum formed retainer and Hawley retainer in terms of maintaining arch expansion post-orthodontic treatment. This would, therefore, mean that there would be a simpler method and would be a suitable more cost-effective alternative as compared to constructing Hawley retainers or adding a palatal wire on the vacuum-formed retainers.
- Conditions
- Orthodontic Retainers, Clinical Trial
- Being tested
- Modified vacuum-formed retainer covering the palete
- Keywords
- Space Maintenance, Palatal Expansion Technique, Recurrence
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified vacuum-formed retainer covering the paleteDevice
Also called Essix retainer covering the palate, Thermoplastic retainer covering the palate
The modified vacuum-formed retainer is made where it would cover the hard palate to the second molars. The only difference in constructing this modified VFR when compared to the normal VFR would be the outline which would be trimmed by the technician.
| Study group | Role | What they receive |
|---|---|---|
| Hawley retainer | Active comparator | Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period. Receives: Device: Modified vacuum-formed retainer covering the palete |
| Modified vacuum-formed retainer covering the palate | Experimental | The modified vacuum-formed retainer is designed to cover the palate. It is cheaper, easier to fabricate and more esthetic. Patients will be instructed to wear the retainer 24 hours during the study period. Receives: Device: Modified vacuum-formed retainer covering the palete |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arch Width
Mean changes across 24-month study period.
Measured: 24-month post-debond
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Aug 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Orthodontic RetainersStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Responsible party
- Principal investigator, ASMA ASHARI, National University of Malaysia
- Investigators
- DR. ASMA ASHARI, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237298
- Sponsor's protocol ID
- GGPM-2018-049
- Status last verified
- Nov 2024
- First submitted
- 4 Oct 2019
- Last updated
- 3 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Relapse Arch Width in Modified Vacuum Formed Retainers Covering the Palate Versus Hawley Retainer: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04237298
- Acronym / sponsor ID
- GGPM-2018-049
- Conditions
- Orthodontic Retainers, Clinical Trial
- Keywords
- Space Maintenance, Palatal Expansion Technique, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Health, Malaysia
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Posted 3 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will focus on the relapse of arch width in two types of retention regimes, which are modified vacuum-formed retainers and Hawley type retainers in patients after fixed appliance treatment in transverse arch expansion cases. This will subsequently be of valuable information for clinicians in choosing the appropriate type of retainers after removal of their fixed appliances. This is because the modified vacuum-formed retainers will be significantly cheaper, quicker and easier to fabricate.
Detailed description
Relapse is inevitable in orthodontic treatment. Teeth will want to return to their original position after fixed appliances are removed. Regardless with or without fixed appliances, changes and physiological relapse will still occur due to time and age changes. This is why retention is a crucial part of orthodontic treatment, where it would aim to maintain the corrections achieved after orthodontic treatment.
Literature regarding retainers is quite substantial, where a recent Cochrane review was published comparing the different types of retainers. However, the evidence is lacking in terms of comparison of arch width relapse between modified vacuum-formed retainers and Hawley retainers specifically in expansion cases.
This study aims to compare the relapse in arch width in expansion cases with modified vacuum-formed retainers with palatal coverage versus Hawley type retainers in Unit Ortodontik Universiti Kebangsaan Malaysia (UKM), Klinik Pakar Ortodontik Klinik Kesihatan Bandar Botanik and Unit Pakar Ortodontik Klinik Pergigian Sungai Chua patients. Although other types of modified vacuum-formed retainers effective for maintaining palatal expansion have been described, these retainers require a wire outlining the Cementoenamel junction of the teeth palatally. This technique requires the experience of the technician, is at a higher cost and requires more lab time. The modified retainer that investigators described in this study would be as efficient and as quick as the normal vacuum-formed retainers, which would usually take a couple of hours to make (same day or next day fit). The present practice at all 3 locations constructs Hawley and normal VFR retainers for all orthodontic patients. There are technicians and laboratory facilities to construct normal VFR as well as Hawley retainer. The only difference between modified and normal vacuum formed retainer is the outline of the retainers where the technician would trim the retainer, where it would cover the hard palate. Therefore it is only the location of trimming that is different using the same special trimming appliances for normal VFRs.
A number of subjects who fulfil the criteria will be invited to participate in this study. The study will involve arch width analysis using study models pre, post-debond, 3 months review post-debond, and 6 months review post-debond. All data will be analyses using Statistical Package for Social Sciences (SPSS). The arch width of participants post-fixed appliances will be compared. Most studies compare the arch width, as well as lower incisor irregularity in evaluating relapse in different groups of retainers. However, there are currently no randomized control trials comparing expansion cases of Hawley vs vacuum-formed retainers, hence why this study will be conducted.
The investigators expect to see no difference between the modified vacuum formed retainer and Hawley retainer in terms of maintaining arch expansion post-orthodontic treatment. This would, therefore, mean that there would be a simpler method and would be a suitable more cost-effective alternative as compared to constructing Hawley retainers or adding a palatal wire on the vacuum-formed retainers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hawley retainer | Active comparator | Device: Modified vacuum-formed retainer covering the paleteStandard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period. |
| Modified vacuum-formed retainer covering the palate | Experimental | Device: Modified vacuum-formed retainer covering the paleteThe modified vacuum-formed retainer is designed to cover the palate. It is cheaper, easier to fabricate and more esthetic. Patients will be instructed to wear the retainer 24 hours during the study period. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who are at least 13 years old at time of debond.
- Treatment plan of extraction or non-extraction followed by straight wire appliances in the upper arch only or both arches
- Undergone more than 3mm of maxillary dentoalveolar expansion. Initially, the amount of arch width expansion was measured intraorally at debond and compared to their respective pre-treatment dental casts. To ensure accuracy, the measurements were repeated on debond and pre-treatment dental casts. The following linear arch width measurements were made: intercanine width (ICW - the distance between the canine cusp tips), interpremolar width (IPMW - the distance between the premolar cusp tips), interfirst molar width 1 (IFMW1 - the distance between the mesiobuccal cusp), and interfirst molar width 2 (IFMW2 - the distance between the distobuccal cusp). At least two or more points were expanded (> 3mm) to be included in the trial.
- No chronic medical conditions
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Modified vacuum-formed retainer covering the paleteAlso: Essix retainer covering the palate, Thermoplastic retainer covering the palateThe modified vacuum-formed retainer is made where it would cover the hard palate to the second molars. The only difference in constructing this modified VFR when compared to the normal VFR would be the outline which would be trimmed by the technician. | Device | Hawley retainer, Modified vacuum-formed retainer covering the palate |
Primary outcome
Arch Width
Time frame: 24-month post-debond
Mean changes across 24-month study period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Orthodontic Retainers
Active, not recruitingObservational study
Comparison Physiological Tooth Mobility and Retention Success in Patients Using Different Retainers
Orthodontic Retainers, Tooth Mobility
Not yet recruiting
Digital vs Conventional VFR in Post-Orthodontic Retention
Periodontal Disease; Gingivitis; Dental Plaque; Malocclusion (Post-orthodontic Treatment)
Active, not recruiting
Retention With Three Different Bonded Retainers a Multicenter, Randomized Controlled Trial With 5-year Follow-up
Dental Malocclusion, Stability
Not yet recruiting
3D-Printed vs Conventional Fixed Retainers After Orthodontic Treatment
Orthodontic Relapse, Malocclusion
Recruiting
Bacterial Diversity Study Using 16S rRNA Sequencing of Periodontal Samples From Patients With Orthodontic Retainers
Fixed Orthodontic Retainer, Orthodontic Appliances, Removable
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.
DR. ASMA ASHARI principal investigator
National University of Malaysia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified vacuum-formed retainer covering the palete in people with Orthodontic Retainers and Clinical Trial, run by National University of Malaysia at 3 sites in Malaysia.
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 1 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 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. 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?
Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Arch Width (time frame: 24-month post-debond). 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 3 Jan 2025.