Effectiveness of Mobile Phone Reminder Applications in Improving Oral Hygiene Compliance of Orthodontic Patients

February 5, 2025 updated by: Shahinaz N. Sembawa, Umm Al-Qura University

The Effectiveness of Mobile Phone Reminders in the Improvement of Oral Hygiene in Patients With Fixed Orthodontic Appliances: A Randomized Controlled Trial

The aim of this Randomized Controlled Trial (RCT) was to investigate the effectiveness of mobile application as an active reminder for improving oral hygiene compliance of patients undergoing orthodontic treatment using fixed orthodontic appliances.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

eligible participants will be randomly assigned to either control or intervention group. Group l (control): Only verbal instructions on oral hygiene including brushing using soft bristles, brushing for 2 minutes, flossing once daily, the use of fluoridated oral rinse, orthodontic appliance care and avoiding hard and sticky food.These instructions were given at the baseline visit. Then, these subjects were re-examined after 4 weeks. Group II (intervention): the subjects received the same oral hygiene instructions that were described to the control group with the addition of downloading two mobile applications: Brushout app and Brush teeth reminder app. These applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene. In addition, oral hygiene practice was tracked by a link that was sent electronically and checked by study researchers as a compliance protocol. Like the control group, subjects were re-examined after 4 weeks.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Mecca, Saudi Arabia
        • Umm Al-Qura University, Dental Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- 1- Subjects having orthodontic treatment using fixed appliances

2- The use of a smartphone to download Brushout app and Brush teeth reminder app

Exclusion Criteria:

  • Subjects having orthodontic treatment using removable appliances

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Verbal oral hygiene instructions group
Only verbal instructions on oral hygiene including brushing using soft bristles, brushing for 2 minutes, flossing once daily, the use of fluoridated oral rinse, orthodontic appliance care and avoiding hard and sticky food. These instructions were given at the baseline visit. Then, these subjects were re-examined after 4 weeks
Experimental: Smartphone reminder application group
the subjects received the same oral hygiene instructions that were described to the control group with the addition of downloading two mobile applications: Brushout app and Brush teeth reminder app. These applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene. In addition, oral hygiene practice was tracked by a link that was sent electronically and checked by study researchers as a compliance protocol. Like the control group, subjects were re-examined after 4 weeks.
Other: Two mobile applications: Brushout and Brush teeth reminder applications
These applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene.
Other Names:
  • reminder applications
  • mobile applications
  • smartphone application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque Index
Time Frame: At baseline and 4 weeks
As described by Silness-Löe plaque index, Six teeth (#16, #12, #24, #36, #32, #44) were used to evaluate the plaque present in each surface including facial, lingual, mesial and distal surface. The thickness of the plaque was measured as follows: 0: absence of microbial plaque, 1: thin film of microbial plaque along the free gingival margin, 2: moderate accumulation with plaque in sulcus, 3: large amount of plaque in sulcus or pocket along the free gingival margin.
At baseline and 4 weeks
Gingival index
Time Frame: At baseline and 4 weeks
Gingival index was used to evaluate the gingival condition in each surface including facial, lingual, mesial and distal. The following scores were used: 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 and tendency to spontaneous bleeding, ulceration.
At baseline and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umm Al-Qura University

Investigators

  • Principal Investigator: Shahinaz N Sembawa, PhD, Umm AlQura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2023

Primary Completion (Actual)

July 31, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HAPO-02-K-012-2023-02-1459
  • +966125270000 (Other Identifier: Umm Al-Qura University)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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