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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04604262
Other study ID # 266235
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date November 26, 2021

Study information

Verified date February 2022
Source York Teaching Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is no long term evidence to show that the use of Waterpik® is effective for orthodontic patients with fixed braces. A Cochrane Systematic Review confirms this. The aims of this study is to find out if the use of Waterpik® in addition to the manual toothbrush is better to maintain clean teeth in patients with fixed braces. The null hypothesis is that there is no difference between patients using either Waterpik® in addition to the manual toothbrush (treatment group) when compared with patients using just the manual toothbrush (control group).


Description:

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Study Design


Related Conditions & MeSH terms

  • Orthodontic Appliance Complication

Intervention

Device:
Waterpik
Waterpik dental water jet

Locations

Country Name City State
United Kingdom York Teaching Hospital NHS Foundation Trust York North Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
York Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Plaque index from baseline The patient will be disclosed by the clinical investigator who will be blind to the toothbrush group allocation. The disclosed mouth will be photographed and plaque scored at the same time. The photograph will allow for a re-score and to check the validity of the clinical score.
Plaque will be assessed on the buccal surfaces of the teeth on which orthodontic brackets has been placed using the orthodontic modification of the Silness and Loe plaque index. This index has been shown to be sensitive in detecting differences in plaque levels in orthodontic patients with fixed braces. This index divides the tooth surface into four zones in relation to the orthodontic bracket: incisal, distal, mesial and cervical and codes 0-3 were assigned.
8, 32, 56 weeks
Primary Change in Gingivitis from baseline Gingivitis will be measured on the buccal surfaces of the teeth with the gingival index using a CPITN probe. 8, 32, 56 weeks
Primary Change in Gingival bleeding from baseline Gingival bleeding will be determined using the Eastman interdental bleeding index. This will involve inserting a wooden interdental cleaner (Interdental woodsticks, Oral-B Laboratories, Aylesbury, UK) between the teeth from the buccal aspect and depressing the interdental papilla by 1-2 mm. The presence or absence of marginal interdental bleeding from the papilla within 15 seconds will be recorded. The Eastman interdental bleeding index is the number of bleeding sites as expressed as a percentage of the total sites evaluated. 8, 32, 56 weeks
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