Quality and Effectiveness of a Personalised App to Support Patients With Fixed Braces

NCT04184739 | Unknown DMC

• 1 other identifier: 124581
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief Summary

Mobile phones are potentially an invaluable tool in improving adherence, they are readily available and can utilised to deliver several approaches to improve adherence simultaneously. A personalised App to help support orthodontic patients ('My Braces') was therefore developed by the researchers. The App provides generic treatment information and also has a personalised element. The personalised element allows patients to input their own treatment information (including progress photographs), set goals, develop plans for achieving these and it provides the patient and clinicians with appropriate dashboards to monitor progress. This research will be conducted at the Eastman Dental Hospital, UCLH Foundation Trust, London. The aim is to assess the effectiveness of the My Braces App, an App designed to support patients undergoing fixed orthodontic treatment. Effectiveness of the My Braces App will be tested by way of a randomised controlled trial. Participants will be allocated to one of three groups: Group A: Standard treatment information (verbal and written) and access to a basic version of the My Braces App with a toothbrushing timer. The timer is necessary as the health behaviour outcome is toothbrushing duration. Group B: As for group A, however, additionally the My Braces App will provide generic treatment information (a combination of videos and text) Group C: As for group B, however, the patients will have access to the full functionality of the My Braces App and the App will allow patients to input their own personalised treatment information (including progress photographs), set goals, develop plans for achieving these and provide the patient and clinicians with appropriate dashboards to monitor progress.

Conditions

Treatment Adherence and Compliance

Outcome Measures

Primary Outcomes (7)

• Toothbrushing duration

  Timed toothbrush use will be determined via the information stored on the App. It is anticipated that participants will not remember to time each brushing episode, therefore, the duration and number of brushing sessions stored within the App will allow for the average brushing duration to be determined. The unit of measurement will be seconds.

  3 months

• Toothbrushing duration

  Timed toothbrush use will be determined via the information stored on the App. It is anticipated that participants will not remember to time each brushing episode, therefore, the duration and number of brushing sessions stored within the App will allow for the average brushing duration to be determined. The unit of measurement will be seconds.

  12 months

• Toothbrushing duration

  Timed toothbrush use will be determined via the information stored on the App. It is anticipated that participants will not remember to time each brushing episode, therefore, the duration and number of brushing sessions stored within the App will allow for the average brushing duration to be determined. The unit of measurement will be seconds.

  End of treatment (24-36 months on average)

• Bleeding score

  A periodontal probe will be utilised, the presence of bleeding within 10 to 30 seconds of probing is indicative of inflammation of the gingivae. Scores will be recorded for all teeth anterior to the molars (incisors, canines and premolars) and will be recorded as the percentage of the total number of tooth surfaces (6 aspects per tooth). A binary score will be assigned to each surface (1 bleeding present, 0 no bleeding).

  Base line (start of treatment)

• Bleeding score

  A periodontal probe will be utilised, the presence of bleeding within 10 to 30 seconds of probing is indicative of inflammation of the gingivae. Scores will be recorded for all teeth anterior to the molars (incisors, canines and premolars) and will be recorded as the percentage of the total number of tooth surfaces (6 aspects per tooth). A binary score will be assigned to each surface (1 bleeding present, 0 no bleeding).

  3 months

• Bleeding score

  A periodontal probe will be utilised, the presence of bleeding within 10 to 30 seconds of probing is indicative of inflammation of the gingivae. Scores will be recorded for all teeth anterior to the molars (incisors, canines and premolars) and will be recorded as the percentage of the total number of tooth surfaces (6 aspects per tooth). A binary score will be assigned to each surface (1 bleeding present, 0 no bleeding).

  12 months

• Bleeding score

  A periodontal probe will be utilised, the presence of bleeding within 10 to 30 seconds of probing is indicative of inflammation of the gingivae. Scores will be recorded for all teeth anterior to the molars (incisors, canines and premolars) and will be recorded as the percentage of the total number of tooth surfaces (6 aspects per tooth). A binary score will be assigned to each surface (1 bleeding present, 0 no bleeding).

  End of treatment (24-36 months on average)

Secondary Outcomes (8)

• Plaque score

  Base line (start of treatment), 3 months, 12 months, and at the end of treatment (24-36 months on average)

• Number of breakages

  3 months, 12 months, and at the end of treatment (24-36 months on average)

• Number of missed appointments

  3 months, 12 months, and at the end of treatment (24-36 months on average)

• Total number of appointments

  At the end of treatment (24-36 months on average)

• Treatment duration

  At the end of treatment (24-36 months on average)

Study Arms (3)

Group A

ACTIVE COMPARATOR

Standard treatment information (verbal and written) and access to a basic version of the App with a toothbrushing timer. The timer is necessary as the health behaviour outcome is toothbrushing duration.

Other: My Braces App

Group B

EXPERIMENTAL

As for group A, however, additionally the App will provide generic treatment information (a combination of videos and text)

Other: My Braces App

Group C

EXPERIMENTAL

As for group B, however, the patients will have access to the full functionality of the App and the App will allow patients to input their own personalised treatment information (including progress photographs), set goals, develop plans for achieving these and provide the patient and clinicians with appropriate dashboards to monitor progress.

Other: My Braces App

Interventions

My Braces App OTHER

An App designed to support patients undertaking orthodontic treatment.

Group A; Group B; Group C

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients accepted for orthodontic treatment utilising fixed orthodontic braces ('train track' braces) at the Eastman Dental Hospital, UCLH Foundation Trust (UCLH EDH)
• years (inclusive) at the start of treatment
• Familiarity with, and daily access to, a smartphone/tablet • Ability to read and communicate in English

You may not qualify if:

• Craniofacial/Orthognathic patients or those with severe hypodontia (developmental absence of teeth); these patients require complex multi-disciplinary treatment. The information need for these patients is therefore different to routine orthodontic treatment
• Communication difficulties (for example, severe autism, learning difficulties)
• Patients who are aware that a family member/friend is enrolled in the study (including a preceding feasibility study, the pilot or RCT) - this is to avoid the patient potentially having access to parts of the App relating to groups other than that the patient is allocated to

Sponsors & Collaborators

• University College, London: lead

Related Publications (1)

• Sharif MO, Newton JT, Cunningham SJ. Assessing the Effectiveness and Acceptability of a Personalized Mobile Phone App in Improving Adherence to Oral Hygiene Advice in Orthodontic Patients: Protocol for a Feasibility Study and a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jan 13;10(1):e18021. doi: 10.2196/18021.

  PMID: 33439142 DERIVED

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Susan J Cunningham, PhD

  UCL Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan J Cunningham, PhD

CONTACT

02034561064; s.cunningham@ucl.ac.uk

Mohammad O Sharif, MSc

CONTACT

mohammad.sharif.16@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: December 4, 2019
• Study Start: October 1, 2020
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 4, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share