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

NCT02866617 | Completed

• 1 other identifier: PPPC/C1-2015/DGD/12
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life

Keywords

Quality of Life; Vacuum formed thermoplastic retainer; Orthodontic study model; 3D reconstructed study model

Outcome Measures

Primary Outcomes (1)

• Oral Health-Related Quality Of Life

  6 month

Secondary Outcomes (1)

• Little's Irregularity Index

  6 month

Other Outcomes (1)

• Patient's compliance on wearing orthodontic retainers

  6 month

Study Arms (2)

Conventional

EXPERIMENTAL

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

3D

EXPERIMENTAL

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

Interventions

Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model DEVICE

3D; Conventional

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• single-arch or sectional fixed appliance treatment,
• hypodontia requiring tooth replacement on the retainer as a temporary measure,
• undergone rapid maxillary expansion,
• indicated for double retention regime (bonded retainers),
• early debonding patients.
• patients intending to relocate within the study period
• patient with learning difficulties and can't read written instructions/questionnaire in English or Malay
• patient with cleft lip or palate
• has undergone surgical treatment

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry, University of Malaya

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (1)

• Mohd Tahir N, Wan Hassan WN, Saub R. Comparing retainers constructed on conventional stone models and on 3D printed models: a randomized crossover clinical study. Eur J Orthod. 2019 Aug 8;41(4):370-380. doi: 10.1093/ejo/cjy063.

  PMID: 30321319 DERIVED

Study Officials

• Wan Nurazreena Wan Hassan, BDS

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2016
• First Posted: August 15, 2016
• Study Start: October 1, 2015
• Primary Completion: January 30, 2017
• Study Completion: March 30, 2017
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

MY (1)