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OpenTrials
Completed

NCT Number: NCT06811688

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umm Al-Qura University, Dental Teaching Hospital

Mecca, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Two mobile applications: Brushout and Brush teeth reminder applications

Other

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Umm Al-Qura University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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