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

NCT03755622 | Unknown DMC

• 1 other identifier: DGD150005
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change of oral health related quality of life between patients wearing conventional TPA and TPA fabricated from 3D reconstructed model from baseline and at 3 months of wear.

  To compare the level of Oral health related quality of life (OHRQoL) between patients wearing conventional Transpalatal Arch and patients wearing Transpalatal Arch fabricated from three dimensionally reconstructed model in three interval times that is after 1 week (T1) , 1 month (T2) and up to three months post Transpalatal Arch cementation (T3). This is achieved by using validated short version Oral Health Impact Factor 14 (OHIP) questionnaire as the instrument. The minimum score per indivudual is 14 and the maximum score is 70. The lesser the score, the better oral health realted quality of life the patient has.

  3 months

Secondary Outcomes (2)

• Change of pain level from baseline to 3 months of wear between patients wearing conventional TPA and TPA fabricated from 3D reconstructed model.

  3 months

• Qualitative evaluation of clinicians preferences regarding clinical application between the conventional TPA and TPA fabricated from 3D reconsructed model.

  3 months

Study Arms (2)

Group C (Conventional)

ACTIVE COMPARATOR

Group C consists of patients who receive Transplatal Arch (TPA) fabricated from conventionally made stone working model.

Device: Conventional Transpalatal Arch (TPA)

Group 3D ( Three Dimensional)

EXPERIMENTAL

Group 3D consists of patients who receive Transpalatal Arch (TPA) made from 3D recontructed model.

Device: Transpalatal Arch (TPA) fabricated from 3D reconstructed model

Interventions

Conventional Transpalatal Arch (TPA) DEVICE

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.

Also known as: Conventionally made TPA

Group C (Conventional)

Transpalatal Arch (TPA) fabricated from 3D reconstructed model DEVICE

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.

Also known as: TPA fabricated on 3D printed model

Group 3D ( Three Dimensional)

Eligibility Criteria

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

You may qualify if:

• Age 18 and above
• Requiring premolar extractions
• Patients do not have previous orthodontic treatment before

You may not qualify if:

• Patient requiring lingual arch, modified TPA, Nance Palatal ArchNon extraction upper arch treatment
• Patients requiring upper arch expansion
• Requiring upper first permanent molar extraction
• Presence of dento-facial anomalies.
• Patients requiring orthognathic surgery

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Postgraduate Orthodontic Clinic, Faculty of Dentistry

Kuala Lumpur, 50603, Malaysia

RECRUITING

Central Study Contacts

Azanee Nur Mohd. Arif Fadzillah

CONTACT

012-5045042; azaneenur@gmail.com

Wan Nurazreena Wan Hassan

CONTACT

+603-79674802; wannurazreena@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients who received the Transpalatal Arch (TPA) are not aware whether the appliance is fabricated conventionally or made from 3D reconstructed study model.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Lecturer at Department of Paediatric Dentistry and Orthodontics, Faculty of Dentistry, University of Malaya

Model Details: Group C : Patients who receive Transpalatal Arch (TPA) that is conventionally constructed on stone models. Group 3D : Patients who receive Transpalatal Arch (TPA) fabricated from three dimensionally (3D) reconstructed study model.

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: November 28, 2018
• Study Start: June 11, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 31, 2019
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)