The Effects of Different Storage Conditions on Removable Retainers

NCT05854953 | Unknown

• 1 other identifier: S2042680
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

removable retainers; wet storage condition; dry storage condition

Outcome Measures

Primary Outcomes (1)

• Microbial colony counts of removable retainers in wet and dry storage conditions

  Removable retainers will be sonicated and vortexed to dislodge bacteria. Serial dilution will be done and bacterial suspension will be pipetted on a BHI agar petri dish. Total bacterial count in CFU/ml will be counted at baseline, T1 and T2.

  6 months

Secondary Outcomes (4)

• Surface roughness of removable retainers in wet and dry storage conditions

  6 months

• Colour stability of removable retainers in wet and dry storage conditions

  6 months

• Compressive strength of removable retainers in wet and dry storage conditions

  6 months

• OHRQoL of participants storing their removable retainers in dry and wet conditions

  6 months

Study Arms (5)

Hawley retainers in dry storage condition

EXPERIMENTAL

Acrylic retainers to be stored in a dry retainer box the entire time when not in use.

Device: Hawley retainers in dry storage condition

Hawley retainers in wet storage condition

EXPERIMENTAL

Acrylic retainers to be stored in a glass of clean tap water the entire time when not in use.

Device: Hawley retainers in wet storage condition

Vacuum-formed retainers in dry storage condition

EXPERIMENTAL

Thermoplastic retainers to be stored in a dry retainer box the entire time when not in use.

Device: VFRs in dry storage condition

Vacuum-formed retainers in wet storage condition

EXPERIMENTAL

Thermoplastic retainers to be stored in a glass of clean tap water the entire time when not in use.

Device: VFRs in wet storage condition

Baseline characteristics

ACTIVE COMPARATOR

Newly constructed Hawley retainers and VFRs will be labeled as baseline samples.

Device: Baseline characteristics

Interventions

Hawley retainers in dry storage condition DEVICE

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

Also known as: Acrylic retainers

Hawley retainers in dry storage condition

Hawley retainers in wet storage condition DEVICE

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

Also known as: Acrylic retainers

Hawley retainers in wet storage condition

VFRs in dry storage condition DEVICE

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

Also known as: Thermoplastic clear retainers

Vacuum-formed retainers in dry storage condition

VFRs in wet storage condition DEVICE

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

Also known as: Thermoplastic clear retainers

Vacuum-formed retainers in wet storage condition

Baseline characteristics DEVICE

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.

Baseline characteristics

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 years and above
• Fixed appliance treatment on both the upper and lower arches
• Ready for debond
• Planned for either Hawley retainers or VFRs for retention
• Fit and healthy patients without systemic disease
• Non-smoking patients

You may not qualify if:

• Sectional fixed appliance treatment or fixed appliance treatment on single arch only
• Planned for double retention with bonded retainers
• Systemic disease that may affect salivary flow
• Smoking patients

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Orthodontic Postgraduate Clinic, Faculty of Dentistry

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

Related Publications (11)

• Ahn HW, Ha HR, Lim HN, Choi S. Effects of aging procedures on the molecular, biochemical, morphological, and mechanical properties of vacuum-formed retainers. J Mech Behav Biomed Mater. 2015 Nov;51:356-66. doi: 10.1016/j.jmbbm.2015.07.026. Epub 2015 Aug 3.

  PMID: 26282078 RESULT

• Ahn HW, Kim KA, Kim SH. A new type of clear orthodontic retainer incorporating multi-layer hybrid materials. Korean J Orthod. 2015 Sep;45(5):268-72. doi: 10.4041/kjod.2015.45.5.268. Epub 2015 Sep 23.

  PMID: 26445722 RESULT

• Al Groosh DH, Bozec L, Pratten J, Hunt NP. The influence of surface roughness and surface dynamics on the attachment of Methicillin-Resistant Staphylococcus aureus onto orthodontic retainer materials. Dent Mater J. 2015;34(5):585-94. doi: 10.4012/dmj.2014-045.

  PMID: 26438981 RESULT

• Alassiry AM. Orthodontic Retainers: A Contemporary Overview. J Contemp Dent Pract. 2019 Jul 1;20(7):857-862.

  PMID: 31597809 RESULT

• Chagas AS, Freitas KMS, Cancado RH, Valarelli FP, Canuto LFG, Oliveira RCG, Oliveira RCG. Level of satisfaction in the use of the wraparound Hawley and thermoplastic maxillary retainers. Angle Orthod. 2020 Jan;90(1):63-68. doi: 10.2319/031319-197.1. Epub 2019 Jul 22.

  PMID: 31335161 RESULT

• Fang J, Wang C, Li Y, Zhao Z, Mei L. Comparison of bacterial adhesion to dental materials of polyethylene terephthalate (PET) and polymethyl methacrylate (PMMA) using atomic force microscopy and scanning electron microscopy. Scanning. 2016 Nov;38(6):665-670. doi: 10.1002/sca.21314. Epub 2016 Mar 15.

  PMID: 26991988 RESULT

• Farhadian N, Usefi Mashoof R, Khanizadeh S, Ghaderi E, Farhadian M, Miresmaeili A. Streptococcus mutans counts in patients wearing removable retainers with silver nanoparticles vs those wearing conventional retainers: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2016 Feb;149(2):155-60. doi: 10.1016/j.ajodo.2015.07.031.

  PMID: 26827971 RESULT

• Kolenbrander PE, Andersen RN, Blehert DS, Egland PG, Foster JS, Palmer RJ Jr. Communication among oral bacteria. Microbiol Mol Biol Rev. 2002 Sep;66(3):486-505, table of contents. doi: 10.1128/MMBR.66.3.486-505.2002.

  PMID: 12209001 RESULT

• Littlewood SJ, Millett DT, Doubleday B, Bearn DR, Worthington HV. Retention procedures for stabilising tooth position after treatment with orthodontic braces. Cochrane Database Syst Rev. 2016 Jan 29;2016(1):CD002283. doi: 10.1002/14651858.CD002283.pub4.

  PMID: 26824885 RESULT

• Marsh PD. Dental plaque as a biofilm and a microbial community - implications for health and disease. BMC Oral Health. 2006 Jun 15;6 Suppl 1(Suppl 1):S14. doi: 10.1186/1472-6831-6-S1-S14.

  PMID: 16934115 RESULT

• Saub R, Locker D, Allison P, Disman M. Cross-cultural adaptation of the Oral Health Impact Profile (OHIP) for the Malaysian adult population. Community Dent Health. 2007 Sep;24(3):166-75.

  PMID: 17958078 RESULT

Central Study Contacts

Amira Farhana Kairul Annuar

CONTACT

+0133936354; s2042680@siswa.um.edu.my

Wan Nurazreena Wan Hassan

CONTACT

+60379674802; wannurazreena@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator will be masked with the randomization sequance \& allocation.
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Paediatric Dentistry & Orthodontics, Faculty of Dentistry

Model Details: Baseline characteristics - newly constructed Hawley and vacuum-formed retainers will be tested for microbial analysis, phyiscal and mechanical properties as comparisons with other groups Group 1 - Participants with Hawley retainers will begin storing their retainers in dry condition, 3 months later, they will change the storage to wet condition. Group 2 - Participants with Hawley retainers will begin storing their retainers in wet condition, 3 months later, they will change the storage to dry condition. Group 3 - Participants with vacuum-formed retainers will begin storing their retainers in dry condition, 3 months later, they will change the storage to wet condition. Group 4 - Participants with vacuum-formed retainers will begin storing their retainers in wet condition, 3 months later, they will change the storage to dry condition.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 11, 2023
• Study Start: May 10, 2023
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)