Compliance, PatientNCT06411847
The Effectiveness of Virtual Appointments on Compliance With Twin Block Wear
A study testing Virtual appointments in people with Compliance, Patient, run by University of Dublin, Trinity College at 2 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Compliance, Patient
- What is being tested?
- Virtual appointments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 2 sitesIreland
- Study dates
- 21 Nov 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Patients receiving treatment with fixed appliances in conjunction with Twin Block treatment
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites, 2 recruiting
- Recruiting
HSE Orthodontic Unit, Loughlinstown
Dublin
Natasha Lemasney, +353 (01) 200 5240, natasha.lemasney@dental.tcd.ie
Mary-Kate Kearney
- Recruiting
HSE Orthodontic Unit, Tallaght
Dublin
Abeer A Hasan, +353 (01) 9214601, abeer.hasan@dental.tcd.ie
Simon Wolstencroft
About this study
Official title: The Effectiveness of Virtual Appointments on Compliance With Twin Block Wear: A Randomised Controlled Trial
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.
Read the detailed description
A Twin Block is a removable functional appliance commonly used in growing patients to correct a Class II malocclusion due to a combination of accelerated mandibular growth and dento-alveolar change. The Twin Block consists of two separate intersecting appliances that hold the lower jaw in a forward-postured position to correct anterior-posterior skeletal and dental relationships, thereby improving the facial profile and reducing the projection of the upper front teeth (overjet). In order to achieve these desired changes, Twin Blocks need to be worn for at least 12 hours per day. Due to the removable nature of the appliance, treatment success is reliant on patient compliance.
Compliance with twin block wear is known to be suboptimal, with non-compliance rates of up to 34% recorded in the literature. This may be attributed to several factors associated with Twin Block wear, such as lack of self-motivation, physical impairment, social concerns and forgetfulness. Virtual appointments could potentially help to address some of these issues.
Previously explored interventions to improve compliance with removable appliances include the use of calendars, known monitoring, conscious hypnosis and establishing implementation intentions. Patients have also recommended the use of visual aids, effective communication tools, positive reinforcement and reminders, all of which may be incorporated within virtual appointments, in improving compliance with Twin Block wear. The effectiveness of virtual appointments in improving Twin Block wear is yet to be assessed.
The use of remote consultation in healthcare offers potential advantages to patients, reducing travel costs and improving convenience, while also potentially enhancing cost-effectiveness and efficiency. Patients report high levels of satisfaction with virtual dental appointments related to ease of use, effectiveness and reliability. Remote communications have been employed successfully to deliver oral health advice, diagnose, monitor development, and provide behaviour guidance for paediatric patients. 'Teledentistry' has been adopted in orthodontics for remote consultations and monitoring, owing to advancements in technology, the need for social distancing during the COVID-19 pandemic, demand and convenience. Notwithstanding this, there is limited evidence available concerning its effectiveness either as a substitute to or an adjunct to conventional in-person visits.
As patients tend to over-report wear time of removable appliances, compliance is better measured objectively through the use of temperature-sensitive microsensors embedded within Twin Block appliances. These devices work by taking frequent readings of the surrounding temperature. When the temperature falls to below that of the intra-oral environment, it suggests the appliance is no longer being worn. The data collected from the sensor is interpreted through dedicated software and can be translated to the number of hours of wear per day. TheraMon® microsensors have been placed in various removable appliances to provide acceptable accuracy in measuring wear-time, with mean under-reporting of 4% and a mean difference of approximately one hour between actual and recorded wear described.
- Conditions
- Compliance, Patient
- Being tested
- Virtual appointments
- Keywords
- Twin Block, Functional Appliances, Compliance
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual appointmentsBehavioural
Also called Remote consultations
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).
| Study group | Role | What they receive |
|---|---|---|
| Virtual Appointment Group | Experimental | This group will receive additional virtual appointments as an adjunct to standard care Receives: Behavioral: Virtual appointments |
| Control Group | No intervention | The group will receive standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data will be collected at standard in-person recall visits at 1 month, 3 month and 6 months.
Secondary outcomes (1)
Occlusal change
Measurement of overjet in millimetres
Measured: Data will be collected at standard in-person recall visits at 1 month, 3 month and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start21 Nov 2023
- Primary completionJun 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Compliance, PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- Dublin Dental University Hospital
- Responsible party
- Principal investigator, Abeer Hasan, University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411847
- Sponsor's protocol ID
- SJH/TUH JREC: 3411
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28826346Al-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.
PubMed 28651764Park 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.
PubMed 33642260
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Virtual Appointments on Compliance With Twin Block Wear: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06411847
- Acronym / sponsor ID
- SJH/TUH JREC: 3411
- Conditions
- Compliance, Patient
- Keywords
- Twin Block, Functional Appliances, Compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- Dublin Dental University Hospital
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A Twin Block is a removable functional appliance commonly used in growing patients to correct a Class II malocclusion due to a combination of accelerated mandibular growth and dento-alveolar change. The Twin Block consists of two separate intersecting appliances that hold the lower jaw in a forward-postured position to correct anterior-posterior skeletal and dental relationships, thereby improving the facial profile and reducing the projection of the upper front teeth (overjet). In order to achieve these desired changes, Twin Blocks need to be worn for at least 12 hours per day. Due to the removable nature of the appliance, treatment success is reliant on patient compliance.
Compliance with twin block wear is known to be suboptimal, with non-compliance rates of up to 34% recorded in the literature. This may be attributed to several factors associated with Twin Block wear, such as lack of self-motivation, physical impairment, social concerns and forgetfulness. Virtual appointments could potentially help to address some of these issues.
Previously explored interventions to improve compliance with removable appliances include the use of calendars, known monitoring, conscious hypnosis and establishing implementation intentions. Patients have also recommended the use of visual aids, effective communication tools, positive reinforcement and reminders, all of which may be incorporated within virtual appointments, in improving compliance with Twin Block wear. The effectiveness of virtual appointments in improving Twin Block wear is yet to be assessed.
The use of remote consultation in healthcare offers potential advantages to patients, reducing travel costs and improving convenience, while also potentially enhancing cost-effectiveness and efficiency. Patients report high levels of satisfaction with virtual dental appointments related to ease of use, effectiveness and reliability. Remote communications have been employed successfully to deliver oral health advice, diagnose, monitor development, and provide behaviour guidance for paediatric patients. 'Teledentistry' has been adopted in orthodontics for remote consultations and monitoring, owing to advancements in technology, the need for social distancing during the COVID-19 pandemic, demand and convenience. Notwithstanding this, there is limited evidence available concerning its effectiveness either as a substitute to or an adjunct to conventional in-person visits.
As patients tend to over-report wear time of removable appliances, compliance is better measured objectively through the use of temperature-sensitive microsensors embedded within Twin Block appliances. These devices work by taking frequent readings of the surrounding temperature. When the temperature falls to below that of the intra-oral environment, it suggests the appliance is no longer being worn. The data collected from the sensor is interpreted through dedicated software and can be translated to the number of hours of wear per day. TheraMon® microsensors have been placed in various removable appliances to provide acceptable accuracy in measuring wear-time, with mean under-reporting of 4% and a mean difference of approximately one hour between actual and recorded wear described.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Appointment Group | Experimental | Behavioral: Virtual appointmentsThis group will receive additional virtual appointments as an adjunct to standard care |
| Control Group | No intervention | –The group will receive standard Care |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients receiving treatment with fixed appliances in conjunction with Twin Block treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual appointmentsAlso: Remote consultationsThis 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). | Behavioural | Virtual Appointment Group |
Primary outcome
Wear Time
Time frame: Data will be collected at standard in-person recall visits at 1 month, 3 month and 6 months.
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.
1 secondary outcome
Occlusal change
Time frame: Data will be collected at standard in-person recall visits at 1 month, 3 month and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Background: PubMed 28826346Brierley 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.
- Background: PubMed 28651764Al-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.
- Background: PubMed 33642260Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual appointments in people with Compliance, Patient, run by University of Dublin, Trinity College at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abeer A Hasan (+353-1-6127200, abeer.hasan@dental.tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wear Time (time frame: Data will be collected at standard in-person recall visits at 1 month, 3 month and 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06411847, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.