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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03109769
Other study ID # FUGRP/2014/191
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 12, 2016
Est. completion date November 4, 2016

Study information

Verified date December 2018
Source Riyadh Colleges of Dentistry and Pharmacy
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to investigate the effect of the use of mobile phone application sending reminders to patients with orthodontic fixed appliances on oral hygiene.


Description:

Subjects were randomized into two groups, the first group received a mobile application that sends active reminders notifications of oral hygiene. The second group received verbal oral hygiene instructions during their regular visits to the orthodontics clinics.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date November 4, 2016
Est. primary completion date July 25, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

1. Participants were having orthodontic fixed appliance treatment.

2. Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.

3. Participants were willing to comply with given oral hygiene instructions.

Study Design


Related Conditions & MeSH terms

  • Orthodontic Appliance Complication

Intervention

Behavioral:
Mobile phone application

Verbal oral hygiene instructions


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Riyadh Colleges of Dentistry and Pharmacy

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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