Comparing Clinical Application of Innovatedly Made Transpalatal Arch (TPA) From 3D Reconstructed Model and Conventionally Made TPA

NCT03755622 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-11-28

No results posted yet for this study

Summary

Trans-palatal Arch or TPA is an intra oral device that is occasionally used in conjunction of orthodontic fixed appliance treatment. It has two main types, the fixed or removable TPA. The purpose of this appliance is to maintain upper jaw's arch width and preventing upper molar teeth from moving forward. It holds the upper molar teeth in their original position so that if any upper teeth are extracted to make room for the others to straighten, the upper molars will not move into the extraction spaces. It comprises of a stainless steel wire with a central semi loop that fits comfortably across but not touching the palate. On each side, it is attached with metal bands around each of the two upper molar teeth.

The construction of TPA requires at least three appointments that take up one to three weeks time. Firstly, an elastic "doughnut" like rubbery separators will be placed between the upper molar teeth using a special tool. Slight tightness is usually felt when the separators are inserted. The whole procedure takes less than a couple of minutes. Patients will be sent away for up to 14 days with the separators in place. For the second appointment, the separators will be removed with dental probe. The correct size metal bands are then selected for the upper molar teeth. Once a correctly fitting band has been chosen, an impression (mould) of the upper teeth with the bands in place will be taken. The impression, together with the bands will be sent to the laboratory for construction of the TPA. Separators will be placed again until patients come back to have TPA fitted.

If the mould of the teeth is scanned and printed out using three dimensions (3D) technology, the number of appointments could be reduced. The second appointment which requires molar bands selection, impression and replacement of separators of upper teeth could be skipped. Molar bands selection can be carried out outside the mouth and straight away sent to the laboratory for TPA construction. All parties involved, patients, clinicians and dental technologists will benefit the innovation by reduction of time spent for TPA related procedure. However, the study that compares innovated TPA from 3D reconstructed models and conventional method has never been done and related similar studies are very scarce.

Conditions

  • Transpalatal Arch (TPA)
  • Oral Health Related Quality of Life (OHRQoL)
  • Oral Health Impact Profile Short Version 14 (OHIP 14)
  • Orthodontic Pain
  • Three Dimensional (3D) Orthodontic Device

Interventions

DEVICE

Conventional Transpalatal Arch (TPA)

In Group C, upper molar bands selection will be carried out by direct intra oral procedure. The conventional TPA is made on the stone working models.

DEVICE

Transpalatal Arch (TPA) fabricated from 3D reconstructed model

In Group 3D, upper molar bands selection will be carried out on the 3D printed model instead of direct intra oral procedure. The 3D TPA will be fabricated on the 3D reconstructed model while the conventional TPA is made on the stone models.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-11
Primary Completion
2019-03-01
Completion
2019-03-31

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 NCT03755622 on ClinicalTrials.gov