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

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. 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.

Study Overview

• Status: Recruiting
• Conditions: Clinical Trial; Orthodontic Retainers
• Intervention / Treatment: Device: Hawley retainer; Device: Modified vacuum-formed retainer covering the palete

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 subjects 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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DR. ASMA ASHARI; Phone Number: +601922208440; Email: asmaashari@ukm.edu.my
• Study Contact Backup: Name: DR. ALIZAE MARNY FAZLIN SYED MOHAMED; Phone Number: +60122276446; Email: alizaemarny@ukm.edu.my

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 50300
    • Recruiting
    • Orthodontic Specialist Clinic
    • Contact: DR. ALIZAE MARNY FAZLIN SYED MOHAMED; Phone Number: +60122276446; Email: alizaemarny@ukm.edu.my
    • Contact: DR. ASMA ASHARI; Phone Number: +60192228440; Email: asmaashari@ukm.edu.my
  • Selangor
    • Kajang, Selangor, Malaysia, 43000
      • Recruiting
      • Unit Pakar Ortodontik Klinik Pergigian Sungai Chua
      • Contact: DR. YEOH CHEW KIT; Phone Number: +60163114942
    • Klang, Selangor, Malaysia, 42000
      • Recruiting
      • Klinik Pakar Ortodontik Klinik Kesihatan Bandar Botanik
      • Contact: DR. MALATHI DEVA TATA; Phone Number: +60172350711
      • Contact: DR. SINDHU; Phone Number: +60173398280

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Hawley retainer; Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period.	Device: Hawley retainer; Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period.
EXPERIMENTAL: 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.	Device: 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.; Other Names: Essix retainer covering the palate; Thermoplastic retainer covering the palate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arch width	Mean changes across 6-month study period.	T0 (at debond)-T1 (3-month post-debond)-T2 (6-month post-debond)

Collaborators and Investigators

• Sponsor: National University of Malaysia
• Investigators: Principal Investigator: DR. ASMA ASHARI, National University of Malaysia

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 24, 2019
• Primary Completion (ANTICIPATED): August 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (ACTUAL): January 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Palatal Expansion Technique; Recurrence; Space Maintenance
• Other Study ID Numbers: GGPM-2018-049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No