Comparison of Modified Vacuum-formed Retainers Versus Hawley Retainer

NCT04237298 | Completed Results DMC

• 1 other identifier: GGPM-2018-049
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

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.

Conditions

Orthodontic Retainers; Clinical Trial

Keywords

Space Maintenance; Palatal Expansion Technique; Recurrence

Outcome Measures

Primary Outcomes (1)

• Arch Width

  Mean changes across 24-month study period.

  24-month post-debond

Study Arms (2)

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.

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.

Device: Modified vacuum-formed retainer covering the palete

Interventions

Modified vacuum-formed retainer covering the palete DEVICE

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.

Also known as: Essix retainer covering the palate, Thermoplastic retainer covering the palate

Hawley retainer; Modified vacuum-formed retainer covering the palate

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead
• Ministry of Health, Malaysia: collaborator

Study Sites (3)

Unit Pakar Ortodontik Klinik Pergigian Sungai Chua

Kajang, Selangor, 43000, Malaysia

Location

Klinik Pakar Ortodontik Klinik Kesihatan Bandar Botanik

Klang, Selangor, 42000, Malaysia

Location

Orthodontic Specialist Clinic

Kuala Lumpur, 50300, Malaysia

Location

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Asma Ashari, Orthodontist and Senior Lecturer, Principal Investigator
• Organization: NUMalaysia

asmaashari@ukm.edu.my

+60192228440

Study Officials

• DR. ASMA ASHARI

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: January 23, 2020
• Study Start: August 1, 2019
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (3)