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The Effects of Different Storage Conditions on Removable Retainers

NCT05854953 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-08-30

No results posted yet for this study

Summary

Orthodontic removable retainers are appliances that hold the position of the upper and lower teeth after fixed braces treatment and they can be removed from a patient's mouth. Basically, there are 2 types of removable retainers; Hawley retainer and vacuum-formed retainer.

Hawley retainer is made of an acrylic resin plate that covers the palate for the upper jaw and the back of the arch facing the tongue for the lower jaw. It has thin stainless-steel wires incorporated to fit the first molars and the six front teeth as retention.

Vacuum-formed retainer (VFR) is a clear or transparent plastic retainer. It covers the teeth completely and a small part of the gum.

The investigators' interest is to determine whether the storage conditions will affect the amount of bacteria, appearance and strength of removable retainers. Primarily, the amount of bacteria that sticks to the retainers may cause overall dental and oral health effects such as mouth odour, dental caries and gum problems. The investigators would also like to assess the oral health-related quality of life (OHRQoL) of participants after storing retainers in different storage conditions by answering a questionnaire.

Conditions

  • Orthodontic Appliance Complication

Interventions

DEVICE

Hawley retainers in dry storage condition

Three months later, an exchange of storage methods from dry to wet conditions will take place.

DEVICE

Hawley retainers in wet storage condition

Three months later, an exchange of storage methods from wet to dry conditions will take place.

DEVICE

VFRs in dry storage condition

Three months later, an exchange of storage methods from dry to wet conditions will take place.

DEVICE

VFRs in wet storage condition

Three months later, an exchange of storage methods from wet to dry conditions will take place.

DEVICE

Baseline characteristics

Hawley retainers and VFRs that are newly constructed will be used as baseline samples. The samples will be taken for microbial, physical and mechanical tests.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2024-03-31
Completion
2024-09-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05854953 on ClinicalTrials.gov