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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03119441
Other study ID # FRP/2016/115
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 13, 2017
Est. completion date October 2019

Study information

Verified date December 2018
Source Riyadh Colleges of Dentistry and Pharmacy
Contact Omar H AlKadhi, BDS, MS
Phone 966505154754
Email omar.alkadhi@riyadh.edu.sa
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 2019
Est. primary completion date June 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Saudi Arabia Riyadh Colleges of Dentistry and Pharmacy Riyadh ArRiyadh

Sponsors (1)

Lead Sponsor Collaborator
Riyadh Colleges of Dentistry and Pharmacy

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Primary 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.
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