Effect of Dental Waterjet on Oral Hygiene for Patients With Braces

• Sponsor: Riyadh Colleges of Dentistry and Pharmacy (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03119441
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 21.6
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Hygiene	Device: Dental Water Jet; Device: Dental Floss	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Efficacy of Dental Water Jet in Plaque Removal During Orthodontic Treatment With Fixed Appliances: A Randomized Controlled Trial
• Actual Study Start Date: Dec 13, 2017
• Anticipated Primary Completion Date: Jun 1, 2019
• Anticipated Study Completion Date: Oct 1, 2019

Arms and Interventions

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 Dental floss	Device: Dental Floss; Dental Floss will be used by subjects to clean their teeth in the interproximal areas.

Outcome Measures

Primary Outcome Measures

1. Change in plaque index [At baseline and after 4 weeks.]

   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.

2. Change in gingival index [At baseline and after 4 weeks.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riyadh Colleges of Dentistry and Pharmacy	Riyadh	ArRiyadh	Saudi Arabia	11681

Sponsors and Collaborators

• Riyadh Colleges of Dentistry and Pharmacy

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omar Alkadhi, Assistant professor, Riyadh Colleges of Dentistry and Pharmacy
• ClinicalTrials.gov Identifier: NCT03119441
• Other Study ID Numbers: FRP/2016/115
• First Posted: Apr 18, 2017
• Last Update Posted: Dec 31, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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

Study Results

No Results Posted as of Dec 31, 2018