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The Effect of Using Mobile Applications for Improving Oral Hygiene

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ClinicalTrials.gov Identifier: NCT03109769
Recruitment Status : Completed
First Posted : April 12, 2017
Results First Posted : November 1, 2017
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Orthodontic Appliance Complication Behavioral: Mobile phone application Behavioral: Verbal oral hygiene instructions

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Using Mobile Applications for Improving Oral Hygiene in Patients With Orthodontic Fixed Appliances: A Randomized Controlled Trial
Actual Study Start Date : February 12, 2016
Primary Completion Date : July 25, 2016
Study Completion Date : November 4, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Mobile phone application
Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.
Behavioral: Mobile phone application
Active Comparator: Verbal oral hygiene instructions
Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.
Behavioral: Verbal oral hygiene instructions


Outcome Measures

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.


Eligibility Criteria

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

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.
Contacts and Locations

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): NCT03109769


Sponsors and Collaborators
Riyadh Colleges of Dentistry and Pharmacy
Investigators
Principal Investigator: Omar H AlKadhi, BDS, MS Riyadh Colleges of Dentistry and Pharmacy
More Information

Responsible Party: Omar Alkadhi, Lecturer, Riyadh Colleges of Dentistry and Pharmacy
ClinicalTrials.gov Identifier: NCT03109769     History of Changes
Other Study ID Numbers: FUGRP/2014/191
First Posted: April 12, 2017    Key Record Dates
Results First Posted: November 1, 2017
Last Update Posted: November 1, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No