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Randomized Controlled Clinical Trial Of Oral Health-Related Quality Of Life In Patients Wearing Vacuum Formed Thermoplastic Retainers Constructed On Conventional Stone Models And On 3D Reconstructed Orthodontic Study Model

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ClinicalTrials.gov Identifier: NCT02866617
Recruitment Status : Completed
First Posted : August 15, 2016
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of Malaya

Study Description
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Brief Summary:

In dentistry, 3D printing technology is gaining interest. One of the potential application is to construct appliances on 3D reconstructed study models.

The purpose of this study is to compare vacuum formed thermoplastic orthodontic retainers (VFR) constructed on conventional orthodontic study models and reconstructed 3D study models by assessing the oral health-related quality of life (OHRQoL) instrument, Little's Irregularity Index (LII) and compliance.


Condition or disease Intervention/treatment Phase
Quality of Life Device: Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Actual Study Start Date : October 2015
Actual Primary Completion Date : January 30, 2017
Actual Study Completion Date : March 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arms and Interventions
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Arm Intervention/treatment
Experimental: Conventional
T1-T2 : VFR constructed on conventional study model T2-T3 : VFR constructed on 3D reconstructed study model
 Device: Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model
Experimental: 3D
T1-T2 : VFR constructed on 3D reconstructed study model T2-T3 :VFR constructed on conventional study model
 Device: Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model


Outcome Measures
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Primary Outcome Measures :
  1. Oral Health-Related Quality Of Life [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Little's Irregularity Index [ Time Frame: 6 month ]

Other Outcome Measures:
  1. Patient's compliance on wearing orthodontic retainers [ Time Frame: 6 month ]
    A survey of patient's compliance wearing the orthodontic retainers in 6 months


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

  1. Inclusion criteria

    1. fixed appliance treatment following both arches;
    2. indicated for vacuum formed thermoplastic retainers as retention phase in treatment plan;

  2. Exclusion criteria:

    1. single-arch or sectional fixed appliance treatment,
    2. hypodontia requiring tooth replacement on the retainer as a temporary measure,
    3. undergone rapid maxillary expansion,
    4. indicated for double retention regime (bonded retainers),
    5. early debonding patients.
    6. patients intending to relocate within the study period
    7. patient with learning difficulties and can't read written instructions/questionnaire in English or Malay
    8. patient with cleft lip or palate
    9. has undergone surgical treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866617


Locations
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Malaysia
Faculty of Dentistry, University of Malaya
Kuala Lumpur, Malaysia, 50603
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Wan Nurazreena Wan Hassan, BDS University of Malaya
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Malaya
ClinicalTrials.gov Identifier: NCT02866617     History of Changes
Other Study ID Numbers: PPPC/C1-2015/DGD/12
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Keywords provided by University of Malaya:
Quality of Life
Vacuum formed thermoplastic retainer
Orthodontic study model
3D reconstructed study model