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Comparison of Modified Vacuum-formed Retainers Versus Hawley Retainer

Comparison of Relapse Arch Width in Modified Vacuum Formed Retainers Covering the Palate Versus Hawley Retainer: A Prospective Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04237298
Enrollment
35
Registered
2020-01-23
Start date
2019-08-01
Completion date
2021-08-31
Last updated
2025-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical Trial, Orthodontic Retainers

Keywords

Space Maintenance, Palatal Expansion Technique, Recurrence

Brief 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. 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.

Interventions

DEVICEModified vacuum-formed retainer covering the palete

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.

Sponsors

Ministry of Health, Malaysia
CollaboratorOTHER_GOV
National University of Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Patients who are at least 13 years old at time of debond. 2. Treatment plan of extraction or non-extraction followed by straight wire appliances in the upper arch only or both arches 3. 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. 4. No chronic medical conditions

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Arch Width24-month post-debondMean changes across 24-month study period.

Countries

Malaysia

Participant flow

Recruitment details

Date of recruitment : 1 Aug 2019 til 31st Aug 221

Pre-assignment details

Excluded: not meeting inclusion criteria, declined to participate

Participants by arm

ArmCount
Hawley Retainer
Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period. Hawley retainer: Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period.
17
Modified Vacuum-formed Retainer Covering the Palate
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. Modified vacuum-formed retainer covering the palete: 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.
18
Total35

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up45

Baseline characteristics

CharacteristicHawley RetainerModified Vacuum-formed Retainer Covering the PalateTotal
Age, Continuous21.88 years
STANDARD_DEVIATION 4.12
22.06 years
STANDARD_DEVIATION 5.88
21.97 years
STANDARD_DEVIATION 5.03
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
12 Participants11 Participants23 Participants
Sex: Female, Male
Male
5 Participants7 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

Arch Width

Mean changes across 24-month study period.

Time frame: 24-month post-debond

Population: arch width (transverse)

ArmMeasureGroupValue (MEAN)
Hawley RetainerArch Widthintercanine width36.9 milimeters
Hawley RetainerArch Widthinterpremolar width44.61 milimeters
Hawley RetainerArch Widthinterfirst molar width 150.74 milimeters
Hawley RetainerArch Widthinterfirst molar width 252.04 milimeters
Modified Vacuum-formed Retainer Covering the PalateArch Widthinterfirst molar width 254.05 milimeters
Modified Vacuum-formed Retainer Covering the PalateArch Widthintercanine width37.65 milimeters
Modified Vacuum-formed Retainer Covering the PalateArch Widthinterfirst molar width 152.86 milimeters
Modified Vacuum-formed Retainer Covering the PalateArch Widthinterpremolar width46.31 milimeters

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026