Treatment Adherence and ComplianceNCT04184739
Quality and Effectiveness of a Personalised App to Support Patients With Fixed Braces
A study testing My Braces App in people with Treatment Adherence and Compliance, run by University College, London.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment Adherence and Compliance
- What is being tested?
- My Braces App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Oct 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients accepted for orthodontic treatment utilising fixed orthodontic braces ('train track' braces) at the Eastman Dental Hospital, UCLH Foundation Trust (UCLH EDH)
- 10-18 years (inclusive) at the start of treatment
- Familiarity with, and daily access to, a smartphone/tablet • Ability to read and communicate in English
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Mohammad O Sharif, MSc contact
About this study
Official title: Investigating the Quality and Effectiveness of a Personalised Mobile App Designed to Support Patients With Fixed (Train Track) Braces: A Randomised Controlled Trial (Student Study)
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.
Read more
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.
Read the detailed description
The National Child Dental Health Survey (England, Wales and Northern Ireland) indicated that 9% of 12 years olds are receiving orthodontic treatment (the use of braces to straighten teeth) and a further 37% have an unmet need. Treatment duration is lengthy (2-3 years on average) and adherence to treatment advice is essential for successful outcomes. It has been reported that up to 43% of patients fail to complete treatment and there are currently no useful predictors of non-completion. The NHS England annual spend on primary care orthodontics is in excess of £200 million, non-completion of treatment therefore represents a significant inefficient use of public resources.
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.
It is important to include Group B as this will allow the team to ascertain whether it is the personalisation of the App content which infers any benefit over and above providing generic information via an App if a difference is found between Groups A and C.
- Conditions
- Treatment Adherence and Compliance
- Being tested
- My Braces App
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Braces AppOther
An App designed to support patients undertaking orthodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: 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. Receives: Other: My Braces App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: End of treatment (24-36 months on average)
Secondary outcomes (8)
Plaque score
Plaque scores will be recorded for all teeth anterior to the molars (incisors, canines and premolars) as the percentage of total surfaces (6 aspects per tooth). A plaque disclosing agent will be used for the plaque assessment. A binary score will be assigned to each surface (1 plaque present, 0 no plaque present).
Measured: Base line (start of treatment), 3 months, 12 months, and at the end of treatment (24-36 months on average)
Number of breakages
Information relating to the number of breakages will be obtained from the patient's medical records.
Measured: 3 months, 12 months, and at the end of treatment (24-36 months on average)
Number of missed appointments
Information relating to the number of missed appointments will be obtained from the patient's medical records.
Measured: 3 months, 12 months, and at the end of treatment (24-36 months on average)
Total number of appointments
Information relating to the number of missed or rescheduled appointments and emergency appointments will be obtained from the patient's medical records.
Measured: At the end of treatment (24-36 months on average)
Treatment duration
Information relating to treatment duration will be obtained from the patient's medical records.
Measured: At the end of treatment (24-36 months on average)
Enamel demineralisation on the front 6 teeth using standardised photographs
For the evaluation of demineralisation, photographs will be assessed and the severity of enamel demineralization will be recorded. The labial surfaces of the upper incisors and canines will be scored as follows:
- No white spot formation
- Slight white spot formation (thin rim)
- Excessive white spot formation (thicker bands) 4. White spot formation with cavitation
Measured: Base line (start of treatment) and at the end of treatment (24-36 months on average)
App subjective quality
Patients will be asked to complete sections E and F of the uMARS questionnaire to ascertain perceived App quality.
Measured: 3 months and at the end of treatment (24-36 months on average)
App engagement (pages accessed and whether this changes with time)
Data relating to App usage will be obtained from the Google Firebase system.
Measured: 3 months, 12 months, and at the end of treatment (24-36 months on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study startOct 2020 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Treatment Adherence and ComplianceStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan J Cunningham, PhD, Principal investigator, UCL Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184739
- Sponsor's protocol ID
- 124581
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33439142
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Quality and Effectiveness of a Personalised Mobile App Designed to Support Patients With Fixed (Train Track) Braces: A Randomised Controlled Trial (Student Study)
- ClinicalTrials.gov ID
- NCT04184739
- Acronym / sponsor ID
- 124581
- Conditions
- Treatment Adherence and Compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 4 Dec 2019 (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.
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.
Detailed description
The National Child Dental Health Survey (England, Wales and Northern Ireland) indicated that 9% of 12 years olds are receiving orthodontic treatment (the use of braces to straighten teeth) and a further 37% have an unmet need. Treatment duration is lengthy (2-3 years on average) and adherence to treatment advice is essential for successful outcomes. It has been reported that up to 43% of patients fail to complete treatment and there are currently no useful predictors of non-completion. The NHS England annual spend on primary care orthodontics is in excess of £200 million, non-completion of treatment therefore represents a significant inefficient use of public resources.
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.
It is important to include Group B as this will allow the team to ascertain whether it is the personalisation of the App content which infers any benefit over and above providing generic information via an App if a difference is found between Groups A and C.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: My Braces AppStandard 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. |
| Group B | Experimental | Other: My Braces AppAs for group A, however, additionally the App will provide generic treatment information (a combination of videos and text) |
| Group C | Experimental | Other: My Braces AppAs 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients accepted for orthodontic treatment utilising fixed orthodontic braces ('train track' braces) at the Eastman Dental Hospital, UCLH Foundation Trust (UCLH EDH)
- 10-18 years (inclusive) at the start of treatment
- Familiarity with, and daily access to, a smartphone/tablet • Ability to read and communicate in English
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| My Braces AppAn App designed to support patients undertaking orthodontic treatment. | Other | Group A, Group B, Group C |
Primary outcome
Toothbrushing duration
Time frame: 3 months
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.
Toothbrushing duration
Time frame: 12 months
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.
Toothbrushing duration
Time frame: End of treatment (24-36 months on average)
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.
Bleeding score
Time frame: Base line (start of treatment)
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).
Bleeding score
Time frame: 3 months
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).
Bleeding score
Time frame: 12 months
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).
Bleeding score
Time frame: End of treatment (24-36 months on average)
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).
8 secondary outcomes
Plaque score
Time frame: Base line (start of treatment), 3 months, 12 months, and at the end of treatment (24-36 months on average)
Number of breakages
Time frame: 3 months, 12 months, and at the end of treatment (24-36 months on average)
Number of missed appointments
Time frame: 3 months, 12 months, and at the end of treatment (24-36 months on average)
Total number of appointments
Time frame: At the end of treatment (24-36 months on average)
Treatment duration
Time frame: At the end of treatment (24-36 months on average)
Enamel demineralisation on the front 6 teeth using standardised photographs
Time frame: Base line (start of treatment) and at the end of treatment (24-36 months on average)
App subjective quality
Time frame: 3 months and at the end of treatment (24-36 months on average)
App engagement (pages accessed and whether this changes with time)
Time frame: 3 months, 12 months, and at the end of treatment (24-36 months on average)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Derived from this study: PubMed 33439142Sharif 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.
- Individual participant dataSharing planned: No
Related trials for Treatment Adherence and Compliance
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
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.
Mohammad O Sharif, MSc contact
Susan J Cunningham, PhD principal investigator
UCL Professor
Questions about this trial
What is this clinical trial studying?
A study testing My Braces App in people with Treatment Adherence and Compliance, run by University College, London.
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 3 inclusion and 3 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 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Susan J Cunningham, PhD (02034561064, s.cunningham@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toothbrushing duration (time frame: 3 months). The study lists 7 primary outcomes in all. 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 NCT04184739, which also lists 1 linked publication.
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 4 Dec 2019.