The Effect of Using Mobile Applications for Improving Oral Hygiene

The Effect of Using Mobile Applications for Improving Oral Hygiene in Patients With Orthodontic Fixed Appliances: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Alkadhi OH, Zahid MN, Almanea RS, Althaqeb HK, Alharbi TH, Ajwa NM. The effect of using mobile applications for improving oral hygiene in patients with orthodontic fixed appliances: a randomised controlled trial. J Orthod. 2017 Sep;44(3):157-163. doi: 10.1080/14653125.2017.1346746. Epub 2017 Jul 13.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2016
• Primary Completion (Actual): July 25, 2016
• Study Completion (Actual): November 4, 2016

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FUGRP/2014/191

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No