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

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.

Study Overview

• Status: Unknown
• Conditions: Oral Hygiene
• Intervention / Treatment: Device: Dental Water Jet; Device: Dental Floss

Detailed Description

Subjects will be randomized into two groups. The first group will receive a dental water jet and the second group will receive dental floss. Plaque accumulation using plaque index and gingival health using gingival index will be measured at baseline and after four weeks for each group and then, results will be compared.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • ArRiyadh
    • Riyadh, ArRiyadh, Saudi Arabia, 11681
      • Recruiting
      • Riyadh Colleges of Dentistry and Pharmacy
      • Contact: Omar H AlKadhi, BDS, MS; Phone Number: +966505154754; Email: omar.alkadhi@riyadh.edu.sa
      • Contact: Sharat C Pani, BDS, MS; Phone Number: +966544981300; Email: sharat@riyadh.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dental water jet; Dental water jet (Jetpik JP210)	Device: Dental Water Jet; Dental Water Jet will be used by subjects to clean their teeth in the interproximal areas.
ACTIVE_COMPARATOR: Dental floss	Device: Dental Floss; Dental Floss will be used by subjects to clean their teeth in the interproximal areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy
• Investigators: Principal Investigator: Omar AlKadhi, BDS, MS, Riyadh Colleges of Dentistry and Pharmacy

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 13, 2017
• Primary Completion (ANTICIPATED): June 1, 2019
• Study Completion (ANTICIPATED): October 1, 2019

Study Registration Dates

• First Submitted: April 13, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (ACTUAL): April 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 31, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FRP/2016/115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No