NCT06811688

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

January 23, 2025

Last Update Submit

February 5, 2025

Conditions

Keywords

Active remindersMobile applicationOral hygieneOrthodontic fixed appliance

Outcome Measures

Primary Outcomes (2)

  • Plaque Index

    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

    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

Study Arms (2)

Verbal oral hygiene instructions group

NO INTERVENTION

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

Smartphone reminder application group

EXPERIMENTAL

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

Interventions

These applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene.

Also known as: reminder applications, mobile applications, smartphone application
Smartphone reminder application group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- 1- Subjects having orthodontic treatment using fixed appliances
  • The use of a smartphone to download Brushout app and Brush teeth reminder app

You may not qualify if:

  • Subjects having orthodontic treatment using removable appliances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umm Al-Qura University, Dental Teaching Hospital

Mecca, Saudi Arabia

Location

Related Publications (4)

  • Jepsen K, Sculean A, Jepsen S. Complications and treatment errors involving periodontal tissues related to orthodontic therapy. Periodontol 2000. 2023 Jun;92(1):135-158. doi: 10.1111/prd.12484. Epub 2023 Mar 15.

    PMID: 36920050BACKGROUND
  • Santonocito S, Polizzi A. Oral Microbiota Changes during Orthodontic Treatment. Front Biosci (Elite Ed). 2022 Jul 27;14(3):19. doi: 10.31083/j.fbe1403019.

    PMID: 36137992BACKGROUND
  • Patil S, Hedad IA, Jafer AA, Abutaleb GK, Arishi TM, Arishi SA, Arishi HA, Jafer M, Gujar AN, Khan S, Raj AT. Effectiveness of mobile phone applications in improving oral hygiene care and outcomes in orthodontic patients. J Oral Biol Craniofac Res. 2021 Jan-Mar;11(1):26-32. doi: 10.1016/j.jobcr.2020.11.004. Epub 2020 Nov 17.

    PMID: 33344158BACKGROUND
  • Pascadopoli M, Zampetti P, Nardi MG, Pellegrini M, Scribante A. Smartphone Applications in Dentistry: A Scoping Review. Dent J (Basel). 2023 Oct 20;11(10):243. doi: 10.3390/dj11100243.

    PMID: 37886928BACKGROUND

Study Officials

  • Shahinaz N Sembawa, PhD

    Umm AlQura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The participants were asked to download 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 23, 2025

First Posted

February 6, 2025

Study Start

February 14, 2023

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

February 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations