Elsadek, Yasmen https://orcid.org/0000-0003-2383-043X
Hamid, Aruche-A-Noor
Anand, Poonam
Simpson, Lucy
Davis, Holly
Kow, Flavian
Mehta, Neha
Fraser, Nina
Turner, Abigail
Lyons-Coleman, Minnie
Cooper, David
,
Pavitt, Sue H.
Funding for this research was provided by:
Oral and Dental Research Trust
Faculty of Medicine and Health, University of Leeds
NHS England X24
NHS West Yorkshire Integrated Care Board
NIHR Clinical Research Network (CRN) Yorkshire and Humber
Article History
Received: 15 November 2024
Accepted: 7 March 2026
First Online: 31 March 2026
Declarations
:
: This study has been approved by the University of Leeds Dental School Research Committee (DREC) for both the RiY Main Study (200218/SP/242-A) and RiY YUK-Oral Bugs sub-study (200218/SP/242-B). Written, informed consent to participate will be obtained from parents/legal guardians of all participants.
: Not applicable.
: University of Leeds c/o Julie McDermott, School of Dentistry, University of Leeds, Worsley Building Level 6, Leeds LS2 9LU.
: A Feasibility joint TSC (also covering Data Monitoring (and Ethics) Committee DM(E)C. has been formed and includes an independent chair and other independent members, such as a statistician, clinician and patient public involvement representatives. Sponsor and funder representatives can also attend as observers. Other members of the research team may attend meetings as and when necessary. The TSC will provide overall guidance of the trial and review feasibility outcomes, modifications and progression criteria. They will ensure that the study is conducted according to the protocol and within the overarching ethical framework. Members will also provide advice outside these meetings according to their area of expertise at key stages.
: The authors declare that they have no competing interests.