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Does a toothbrushing support app improve oral hygiene in children and young people?

Clara Trial A: a two-arm parallel study evaluating whether use of the Clara brushing-support app is associated with changes in plaque and gum-health measures in children aged 8–15 years

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11164198
Enrollment
88
Registered
2026-07-23
Start date
2026-08-31
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral hygiene (plaque) Oral Health

Interventions

Participants will be randomised by computer-generated random number sequence into one of two arms: Intervention: the use of the Clara Brushing support App on a mobile phone or tablet Control: usual br

Sponsors

The Toothcare Project Ltd
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Aged 8–15 years inclusive at the time of consent 2. Attending Hafren House Dental Practice as a routine patient 3. Parent/guardian able and willing to give written informed consent 4. Child able and willing to give verbal assent (age-appropriate band: 8–12 or 13–15) 5. Access to a compatible device on which the Clara app can be installed (Clara arm only; eligibility confirmed prior to randomisation for both arms)

Exclusion criteria

Exclusion criteria: 1. Acute oral health condition requiring urgent dental care at screening 2. Medical or developmental condition that, in the judgement of the site lead, would make participation unsafe or impracticable 3. Wearing a fixed or removable appliance is not an exclusion criteria 4. Concurrent participation in another oral-health interventional study

Design outcomes

Primary

MeasureTime frame
Dental plaque score measured using the Turesky Modification of the Quigley-Hein Index (TMQHI) at baseline and 4 weeks

Secondary

MeasureTime frame
Brushing behaviour, app engagement and satisfaction measured using a questionnaire and use measured via the brushing support app at the end of the study;Adverse events associated with trial participation measured using a questionnaire at the end of the study

Countries

England, United Kingdom

Contacts

Public ContactChristopher;Bhupinder Deery;Dawett

;

c.deery@sheffield.ac.uk;reception@hafrenhousedental.co.uk+44 (0)7787306437;+44 (0)1773 832158

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026