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Effect of Dental Waterjet on Oral Hygiene for Patients With Braces

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119441
Recruitment Status : Unknown
Verified December 2018 by Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy.
Recruitment status was:  Recruiting
First Posted : April 18, 2017
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Omar Alkadhi, Riyadh Colleges of Dentistry and Pharmacy

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 13, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in plaque index [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119441


Contacts
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Contact: Omar H AlKadhi, BDS, MS 966505154754 omar.alkadhi@riyadh.edu.sa
Contact: Osamah M ALMugeiren, BDS, MS +966543177777 o.almugeiren@riyadh.edu.sa

Locations
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Saudi Arabia
Riyadh Colleges of Dentistry and Pharmacy Recruiting
Riyadh, ArRiyadh, Saudi Arabia, 11681
Contact: Omar H AlKadhi, BDS, MS    +966505154754    omar.alkadhi@riyadh.edu.sa   
Contact: Sharat C Pani, BDS, MS    +966544981300    sharat@riyadh.edu.sa   
Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
Investigators
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Principal Investigator: Omar AlKadhi, BDS, MS Riyadh Colleges of Dentistry and Pharmacy
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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: April 18, 2017    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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