Effect of Dental Waterjet on Oral Hygiene for Patients With Braces
The Efficacy of Dental Water Jet in Plaque Removal During Orthodontic Treatment With Fixed Appliances: A Randomized Controlled Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
The aim of this study is to assess the efficacy of dental water jet in plaque removal and gingival health during orthodontic treatment with fixed appliances.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedStudy Start
First participant enrolled
December 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedDecember 31, 2018
December 1, 2018
1.5 years
April 13, 2017
December 27, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Change in plaque index
Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque.
At baseline and after 4 weeks.
Change in gingival index
Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding.
At baseline and after 4 weeks.
Study Arms (2)
Dental water jet
EXPERIMENTALDental water jet (Jetpik JP210)
Dental floss
ACTIVE COMPARATORDental floss
Interventions
Dental Water Jet will be used by subjects to clean their teeth in the interproximal areas.
Dental Floss will be used by subjects to clean their teeth in the interproximal areas.
Eligibility Criteria
You may qualify if:
- Subjects having orthodontic fixed appliance.
- Subjects aged 12 years old and above who own mobile phones and no mental or physical disabilities.
- Subjects willing to comply with given oral hygiene instructions.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Riyadh Colleges of Dentistry and Pharmacy
Riyadh, ArRiyadh, 11681, Saudi Arabia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar AlKadhi, BDS, MS
Riyadh Colleges of Dentistry and Pharmacy
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
April 13, 2017
First Posted
April 18, 2017
Study Start
December 13, 2017
Primary Completion
June 1, 2019
Study Completion
October 1, 2019
Last Updated
December 31, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share