Orthodontic Appliance ComplicationNCT05854953
The Effects of Different Storage Conditions on Removable Retainers
A study testing Hawley retainers in dry storage condition, Hawley retainers in wet storage condition and VFRs in dry storage condition in people with Orthodontic Appliance Complication, run by University of Malaya at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Hawley retainers in dry storage condition, Hawley retainers in wet storage condition and VFRs in dry storage condition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteMalaysia
- Study dates
- 10 May 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
Orthodontic Postgraduate Clinic, Faculty of Dentistry
Kuala Lumpur, Kuala Lumpur, 50603
Amira Farhana Kairul Annuar, +60133936254, s2042680@siswa.um.edu.my
Wan Nurazreena Wan Hassan, +60379674802, wannurazreena@um.edu.my
About this study
Official title: A Randomised Crossover Clinical Trial to Compare the Effects of Different Storage Conditions on Removable Retainers
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.
Read more
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.
Read the detailed description
RATIONALE OF THE STUDY
A non-bias clinical study is required to facilitate the best recommendation to care for the orthodontic retainers. This may prevent the risk of further harms to the oral condition and increase the longevity of the retainers. In turn, this would improve the OHRQoL of orthodontic patients and potentially save the cost of retainer replacements. Therefore, the findings may help to provide evidence-based guidelines for the storage method of removable retainers.
Primary Objective
- To compare the microbial colony counts of removable retainers in wet and dry storage conditions. Secondary Objectives
- To compare the surface roughness of removable retainer materials in wet and dry storage conditions.
- To compare the colour stability of removable retainer materials in wet and dry storage conditions.
- To compare the compressive strength of removable retainer materials in wet and dry storage conditions.
- To evaluate OHRQoL of participants storing their removable retainers in dry and wet conditions.
SAMPLE SIZE CALCULATION
Sample size calculation was done using G* Power 3.1. The total sample size is 18, for an alpha error equivalent to 0.05, a study power equivalent to 80%, a two-sided test type, and an effect size of 1.316 (Farhadian et al., 2016). Considering a potential dropout of 30%, therefore 24 participants will be recruited.
METHODOLOGY
Participants who fit the inclusion and exclusion criteria will be invited to enrol at the Orthodontic Postgraduate Clinic, Faculty of Dentistry, Universiti Malaya. Once the participants consent to take part in this study, an explanation will be given in detail of the procedure of the research with the aid of the flowchart diagram. The participants will also be given a participant information sheet. An appointment for the removal of fixed braces will be scheduled.
All participants will be required to draw lots from the sealed envelope which has been randomised by the consultant orthodontist to know their first retainer storage condition. The investigator will have to check the group allocation with the consultant orthodontist.
On the first appointment day, the removal of braces will be done according to the standard protocol. Then, four sets of impressions will be taken to construct the models and retainers. The participants will be issued with their regular upper and lower retainers, a new toothbrush and a retainer box. The participants will be instructed to store their retainers in a dry retainer box or in a glass of clean water the entire time when not in use. Other home care instructions include: 1) wear the retainers part-time (8-12 hours daily), 2) clean the retainers with a soft-bristled toothbrush and rinse thoroughly, and 3) no additional cleaning solutions and tablets are allowed. The participants will need to answer a self-administered questionnaire 1 week later to assess their personal judgment on the removable retainers.
The participants will be called 3 months later for review (T1). During this visit, the standard retainers will be taken by the investigator for analysis. The interventional retainers will be issued to the participants with an instruction to exchange the storage method from dry to wet conditions and from wet to dry conditions. The same home care instructions will be advised. The participants will receive a new toothbrush to clean their appliance and a new retainer box to keep their retainers. The participants will need to answer a questionnaire sheet again.
The participants will be called 6 months later for review (T2). The first interventional retainers will be taken by the investigator for the final analysis. The second interventional retainers will be issued to the participants and they will be instructed to continue caring for their retainers. All participants will be required to answer a questionnaire sheet for the final time.
Three different sets of the newly constructed Hawley and vacuum-formed retainers will be tested for microbial analysis, physical and mechanical properties as baseline characteristics for comparisons.
STATISTICAL ANALYSIS
Results obtained will be computed using SPSS Statistics for Windows, Version 26.0. Statistical significance will be set at p < 0.05.
The manipulating variables are the types of storage conditions, which are dry and wet with α = 5% = 0.05 and confidence interval (CI) of 95%. Test of normality will be done using the Shapiro-Wilk test for each of the dependent variables (outcomes).
- Mann-Whitney U-Test will be applied to compare the dependent variables of the two groups (Hawley retainers and VFRs) at baseline, T1 and T2. ii. Wilcoxon Signed Rank test will be used to compare the storage conditions of the two groups (Hawley retainers and VFRs) at baseline, T1 and T2. iii. Kruskal Wallis will be carried out to investigate the interaction between the two samples and the storage conditions. iv. If the data is normally distributed, then the equivalent parametric analyses (paired t-test and independent t-test) will be performed.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Hawley retainers in dry storage condition, Hawley retainers in wet storage condition, VFRs in dry storage condition, VFRs in wet storage condition, Baseline characteristics
- Keywords
- removable retainers, wet storage condition, dry storage condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hawley retainers in dry storage conditionDevice
Also called Acrylic retainers
Three months later, an exchange of storage methods from dry to wet conditions will take place.
Hawley retainers in wet storage conditionDevice
Also called Acrylic retainers
Three months later, an exchange of storage methods from wet to dry conditions will take place.
VFRs in dry storage conditionDevice
Also called Thermoplastic clear retainers
Three months later, an exchange of storage methods from dry to wet conditions will take place.
VFRs in wet storage conditionDevice
Also called Thermoplastic clear retainers
Three months later, an exchange of storage methods from wet to dry conditions will take place.
Baseline characteristicsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hawley retainers in dry storage condition | Experimental | Acrylic retainers to be stored in a dry retainer box the entire time when not in use. Receives: 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. Receives: 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. Receives: 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. Receives: Device: VFRs in wet storage condition |
| Baseline characteristics | Active comparator | Newly constructed Hawley retainers and VFRs will be labeled as baseline samples. Receives: Device: Baseline characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (4)
Surface roughness of removable retainers in wet and dry storage conditions
Surface roughness will be measured with a surface roughness profilometer (Mitutoyo, Japan). A stylus will make a contact on a surface of the removable retainer and give a measurement in Ra (average surface roughness) parameter. Reading will be taken at baseline, T1 and T2.
Measured: 6 months
Colour stability of removable retainers in wet and dry storage conditions
The colour changes of the removable retainers will be measured with a colour spectrophotometer (Konica Minolta, Japan) at baseline, T1 and T2.
Measured: 6 months
Compressive strength of removable retainers in wet and dry storage conditions
Compressive strength will be done using a universal testing machine (AG-X Series, Shimadzu, Japan). 5 kN compressive load with a loading rate of 1.0 mm/min will be applied at baseline, T1 and T2.
Measured: 6 months
OHRQoL of participants storing their removable retainers in dry and wet conditions
The questionnaire is modified following a similar study of a randomised crossover clinical study comparing vacuum-formed thermoplastic retainers constructed on a conventional stone models and on 3D reconstructed study model.
The OHRQoL is measured by using a modified 14-item Malaysian version of the Oral Health Impact Profile [OHIP-14(M)].
The content focuses on the impact of oral health on quality of life through seven domains: 1) functional limitation, 2) physical pain, 3) psychological discomfort, 4) physical disability, 5) psychological disability, 6) social disability, and 7) handicap. Likert scale is used to measure the score for the responses; 0 = never, 1 = hardly ever, 2 = occasionally, 3 = fairly often, 4 = very often.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start10 May 2023
- Primary completionMar 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Wan Nurazreena Wan Hassan, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05854953
- Sponsor's protocol ID
- S2042680
- Status last verified
- Aug 2023
- First submitted
- 17 Apr 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26282078Ahn 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.
PubMed 26445722Al 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.
PubMed 26438981Alassiry AM. Orthodontic Retainers: A Contemporary Overview. J Contemp Dent Pract. 2019 Jul 1;20(7):857-862.
PubMed 31597809Chagas 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.
PubMed 31335161Fang 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.
PubMed 26991988Farhadian 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.
PubMed 26827971Kolenbrander 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.
PubMed 12209001Littlewood 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.
PubMed 26824885Marsh 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.
PubMed 16934115Saub 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.
PubMed 17958078
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Crossover Clinical Trial to Compare the Effects of Different Storage Conditions on Removable Retainers
- ClinicalTrials.gov ID
- NCT05854953
- Acronym / sponsor ID
- S2042680
- Conditions
- Orthodontic Appliance Complication
- Keywords
- removable retainers, wet storage condition, dry storage condition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 11 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RATIONALE OF THE STUDY
A non-bias clinical study is required to facilitate the best recommendation to care for the orthodontic retainers. This may prevent the risk of further harms to the oral condition and increase the longevity of the retainers. In turn, this would improve the OHRQoL of orthodontic patients and potentially save the cost of retainer replacements. Therefore, the findings may help to provide evidence-based guidelines for the storage method of removable retainers.
Primary Objective
- To compare the microbial colony counts of removable retainers in wet and dry storage conditions. Secondary Objectives
- To compare the surface roughness of removable retainer materials in wet and dry storage conditions.
- To compare the colour stability of removable retainer materials in wet and dry storage conditions.
- To compare the compressive strength of removable retainer materials in wet and dry storage conditions.
- To evaluate OHRQoL of participants storing their removable retainers in dry and wet conditions.
SAMPLE SIZE CALCULATION
Sample size calculation was done using G* Power 3.1. The total sample size is 18, for an alpha error equivalent to 0.05, a study power equivalent to 80%, a two-sided test type, and an effect size of 1.316 (Farhadian et al., 2016). Considering a potential dropout of 30%, therefore 24 participants will be recruited.
METHODOLOGY
Participants who fit the inclusion and exclusion criteria will be invited to enrol at the Orthodontic Postgraduate Clinic, Faculty of Dentistry, Universiti Malaya. Once the participants consent to take part in this study, an explanation will be given in detail of the procedure of the research with the aid of the flowchart diagram. The participants will also be given a participant information sheet. An appointment for the removal of fixed braces will be scheduled.
All participants will be required to draw lots from the sealed envelope which has been randomised by the consultant orthodontist to know their first retainer storage condition. The investigator will have to check the group allocation with the consultant orthodontist.
On the first appointment day, the removal of braces will be done according to the standard protocol. Then, four sets of impressions will be taken to construct the models and retainers. The participants will be issued with their regular upper and lower retainers, a new toothbrush and a retainer box. The participants will be instructed to store their retainers in a dry retainer box or in a glass of clean water the entire time when not in use. Other home care instructions include: 1) wear the retainers part-time (8-12 hours daily), 2) clean the retainers with a soft-bristled toothbrush and rinse thoroughly, and 3) no additional cleaning solutions and tablets are allowed. The participants will need to answer a self-administered questionnaire 1 week later to assess their personal judgment on the removable retainers.
The participants will be called 3 months later for review (T1). During this visit, the standard retainers will be taken by the investigator for analysis. The interventional retainers will be issued to the participants with an instruction to exchange the storage method from dry to wet conditions and from wet to dry conditions. The same home care instructions will be advised. The participants will receive a new toothbrush to clean their appliance and a new retainer box to keep their retainers. The participants will need to answer a questionnaire sheet again.
The participants will be called 6 months later for review (T2). The first interventional retainers will be taken by the investigator for the final analysis. The second interventional retainers will be issued to the participants and they will be instructed to continue caring for their retainers. All participants will be required to answer a questionnaire sheet for the final time.
Three different sets of the newly constructed Hawley and vacuum-formed retainers will be tested for microbial analysis, physical and mechanical properties as baseline characteristics for comparisons.
STATISTICAL ANALYSIS
Results obtained will be computed using SPSS Statistics for Windows, Version 26.0. Statistical significance will be set at p < 0.05.
The manipulating variables are the types of storage conditions, which are dry and wet with α = 5% = 0.05 and confidence interval (CI) of 95%. Test of normality will be done using the Shapiro-Wilk test for each of the dependent variables (outcomes).
- Mann-Whitney U-Test will be applied to compare the dependent variables of the two groups (Hawley retainers and VFRs) at baseline, T1 and T2. ii. Wilcoxon Signed Rank test will be used to compare the storage conditions of the two groups (Hawley retainers and VFRs) at baseline, T1 and T2. iii. Kruskal Wallis will be carried out to investigate the interaction between the two samples and the storage conditions. iv. If the data is normally distributed, then the equivalent parametric analyses (paired t-test and independent t-test) will be performed.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 5
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hawley retainers in dry storage condition | Experimental | Device: Hawley retainers in dry storage conditionAcrylic retainers to be stored in a dry retainer box the entire time when not in use. |
| Hawley retainers in wet storage condition | Experimental | Device: Hawley retainers in wet storage conditionAcrylic retainers to be stored in a glass of clean tap water the entire time when not in use. |
| Vacuum-formed retainers in dry storage condition | Experimental | Device: VFRs in dry storage conditionThermoplastic retainers to be stored in a dry retainer box the entire time when not in use. |
| Vacuum-formed retainers in wet storage condition | Experimental | Device: VFRs in wet storage conditionThermoplastic retainers to be stored in a glass of clean tap water the entire time when not in use. |
| Baseline characteristics | Active comparator | Device: Baseline characteristicsNewly constructed Hawley retainers and VFRs will be labeled as baseline samples. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hawley retainers in dry storage conditionAlso: Acrylic retainersThree months later, an exchange of storage methods from dry to wet conditions will take place. | Device | Hawley retainers in dry storage condition |
| Hawley retainers in wet storage conditionAlso: Acrylic retainersThree months later, an exchange of storage methods from wet to dry conditions will take place. | Device | Hawley retainers in wet storage condition |
| VFRs in dry storage conditionAlso: Thermoplastic clear retainersThree months later, an exchange of storage methods from dry to wet conditions will take place. | Device | Vacuum-formed retainers in dry storage condition |
| VFRs in wet storage conditionAlso: Thermoplastic clear retainersThree months later, an exchange of storage methods from wet to dry conditions will take place. | Device | Vacuum-formed retainers in wet storage condition |
| Baseline characteristicsHawley retainers and VFRs that are newly constructed will be used as baseline samples. The samples will be taken for microbial, physical and mechanical tests. | Device | Baseline characteristics |
Primary outcome
Microbial colony counts of removable retainers in wet and dry storage conditions
Time frame: 6 months
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.
4 secondary outcomes
Surface roughness of removable retainers in wet and dry storage conditions
Time frame: 6 months
Colour stability of removable retainers in wet and dry storage conditions
Time frame: 6 months
Compressive strength of removable retainers in wet and dry storage conditions
Time frame: 6 months
OHRQoL of participants storing their removable retainers in dry and wet conditions
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Results publication: PubMed 26282078Ahn 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.
- Results publication: PubMed 26445722Ahn 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.
- Results publication: PubMed 26438981Al 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.
- Results publication: PubMed 31597809Alassiry AM. Orthodontic Retainers: A Contemporary Overview. J Contemp Dent Pract. 2019 Jul 1;20(7):857-862.
- Results publication: PubMed 31335161Chagas 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.
- Results publication: PubMed 26991988Fang 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.
- Results publication: PubMed 26827971Farhadian 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.
- Results publication: PubMed 12209001Kolenbrander 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.
- Results publication: PubMed 26824885Littlewood 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.
- Results publication: PubMed 16934115Marsh 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.
- Results publication: PubMed 17958078Saub 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.
- Individual participant dataSharing planned: No
Related trials for Orthodontic Appliance Complication
Recruiting
Bacterial Diversity Study Using 16S rRNA Sequencing of Periodontal Samples From Patients With Orthodontic Retainers
Fixed Orthodontic Retainer, Orthodontic Appliances, Removable
Recruiting
Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment
White Spot Lesions, Orthodontic Appliance Complication
Recruiting
The Effect of Intraoral Transcutaneous Electrical Nerve Stimulation in Orthodontics Pain
Orthodontic Appliance, Pain
Not yet recruiting
Comparison of a 3-step Bonding System (Transbond™ XT) and a 2-step System (GC Ortho Connect™) on Demineralization Around Maxillary Orthodontic Brackets
Tooth Demineralization, White Spot Lesion
Recruiting
Microbial Adherence, Surface Roughness, Effectiveness and Impact on Patients Between Conventional and 3D Printed Twin Block Appliances
Orthodontic Appliances, Removable, Orthodontic Appliance Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hawley retainers in dry storage condition, Hawley retainers in wet storage condition and VFRs in dry storage condition in people with Orthodontic Appliance Complication, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Farhana Kairul Annuar (+0133936354, s2042680@siswa.um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial colony counts of removable retainers in wet and dry storage conditions (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05854953, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.