The Effectiveness of Virtual Appointments on Compliance With Twin Block Wear

NCT06411847 | Recruiting

• 1 other identifier: SJH/TUH JREC: 3411
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators aim to determine the effect of virtual appointments on compliance with Twin Block wear. Patients satisfying the inclusion criteria requiring a Twin Block appliance will be requested to participate in the study. Those selected will be allocated to either the intervention or control group. The control group will receive routine verbal instruction and a standard information leaflet at the start of their treatment. The intervention group will additionally receive virtual appointments over the initial period of treatment involving focussed discussion on twin block wear experience and use of visual aids. Wear time will be objectively recorded in both groups using a temperature-sensitive microsensor embedded in the Twin Block appliance, and occlusal changes will be measured at each standard recall visit. A comparison of the data obtained from each group will be undertaken to determine whether there is a significant difference in compliance with twin block wear between participants who receive adjunctive virtual appointments to those who do not.

Conditions

Compliance, Patient

Keywords

Twin Block; Functional Appliances; Compliance

Outcome Measures

Primary Outcomes (1)

• Wear Time

  Wear time in minutes will be recorded by a Theramon® microsensor (Handelsagentur Gschladt, Hargelsberg, Austria, or Forestadent, Pforzheim, Germany) embedded in the maxillary appliance, supplemented with a self-completed wear chart.

  Data will be collected at standard in-person recall visits at 1 month, 3 month and 6 months.

Secondary Outcomes (1)

• Occlusal change

  Data will be collected at standard in-person recall visits at 1 month, 3 month and 6 months.

Study Arms (2)

Virtual Appointment Group

EXPERIMENTAL

This group will receive additional virtual appointments as an adjunct to standard care

Behavioral: Virtual appointments

Control Group

NO INTERVENTION

The group will receive standard Care

Interventions

Virtual appointments BEHAVIORAL

This group will receive the same information as the control group with additional virtual appointments at 1 week, 2 weeks and 6 weeks after fitting a Twin Block appliance. These will be scheduled and held via BlueEye Clinic (RedZinc Services Ltd.), a web-based GDPR compliant platform that allows patients to access a remote video consultation via a link sent to the participant/parent's device. The content of these appointments will follow a template that addresses the patient's experience, difficulties faced and how to overcome these, and would incorporate use of visual aids to highlight expected changes over the duration of wear. The appointments would be held in the late afternoons (after school).

Also known as: Remote consultations

Virtual Appointment Group

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Males 11-14 years old, Females 10-13 years old at start of Twin Block treatment
• Class II division 1 incisor relationship with an overjet ≥ 7mm
• Access to a smartphone with a microphone and camera
• Willingness to participate in the study

You may not qualify if:

• \- Patients receiving treatment with fixed appliances in conjunction with Twin Block treatment

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• Dublin Dental University Hospital: collaborator

Study Sites (2)

HSE Orthodontic Unit, Loughlinstown

Dublin, Ireland

RECRUITING

HSE Orthodontic Unit, Tallaght

Dublin, Ireland

RECRUITING

Related Publications (3)

• Brierley CA, Benson PE, Sandler J. How accurate are TheraMon(R) microsensors at measuring intraoral wear-time? Recorded vs. actual wear times in five volunteers. J Orthod. 2017 Dec;44(4):241-248. doi: 10.1080/14653125.2017.1365220. Epub 2017 Aug 22.

  PMID: 28826346 BACKGROUND

• Al-Moghrabi D, Salazar FC, Pandis N, Fleming PS. Compliance with removable orthodontic appliances and adjuncts: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2017 Jul;152(1):17-32. doi: 10.1016/j.ajodo.2017.03.019.

  PMID: 28651764 BACKGROUND

• Park JH, Kim JH, Rogowski L, Al Shami S, Howell SEI. Implementation of teledentistry for orthodontic practices. J World Fed Orthod. 2021 Mar;10(1):9-13. doi: 10.1016/j.ejwf.2021.01.002. Epub 2021 Feb 25.

  PMID: 33642260 BACKGROUND

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Abeer A Hasan

CONTACT

+353-1-6127200; abeer.hasan@dental.tcd.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Registrar in Orthodontics

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 13, 2024
• Study Start: November 21, 2023
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (2)