Effectiveness of Waterpik in patients with fixed braces
Research type
Research Study
Full title
A randomised controlled clinical trial to determine if the use of the Waterpik® in addition to the standard toothbrush maintains cleaner teeth in patients with fixed braces
IRAS ID
266235
Contact name
Hock Hoe Goh
Contact email
Sponsor organisation
York Teaching Hospital Foundation NHS Trust
Duration of Study in the UK
2 years, 1 months, 28 days
Research summary
Accumulation of plaque on tooth surfaces that have fixed orthodontic appliances is increased. Effective removal is essential to maintain oral health but it is unclear whether the use of the Waterpik (which is a dental water flosser) is useful.\n\nWe will compare the effectiveness of the Waterpik with manual toothbrushes and just manual toothbrushes alone used by patients during fixed orthodontic braces in relation to plaque removal, the health of dental and supporting tissues, dependability, cost and adverse effects.\n\nThis will be a 56 week single blind, stratified; parallel group randomised controlled clinical trial. This will be a pseudo-longitudinal trial where observations are recorded at certain fixed intervals. The CONSORT guidelines for reporting randomised control trials will be followed. Examinations will be conducted at baseline, 8, 32 and 56 weeks.\nEthical approval will be obtained prior to the commencement of the trial. Subjects will be recruited from all patients seen for fixed brace treatment. They will be allowed to withdraw freely at any time.\nTo ensure conformity, patients will be provided with a manual toothbrush, toothpaste and those requiring it, the Waterpik. The inclusion criteria for the subjects, gold standard, intervention, and outcome measures are set below.\nPatients will be shown how to get around the brackets and wires with a model with a manual toothbrush and the Waterpik if they are allocated by the same dental nurse. However, they will only be required to use the Waterpik once a day, last thing at night. This will last an additional two minutes. The rest of instructions will be the same as those for patients using the manual toothbrush.\nOutcome measure will be Oral hygiene (gingivitis and gingival bleeding)
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
19/YH/0206
Date of REC Opinion
21 Aug 2019
REC opinion
Further Information Favourable Opinion