NCT05853276

Brief Summary

In this day and age, smartphones are occupying big portions of our lives. Expanding development of mobile applications focusing on delivering behavioral health intervention have intrigued us to know better about their efficacy. Hence the present study was conducted to determine the effectiveness of the Brush DJ app on improving the oral hygiene compliance of patients wearing fixed orthodontic appliances by assessing their gingival status. Null hypothesis: There was no difference in the gingival status and oral hygiene status of patients between verbal oral hygiene instructions and oral hygiene instructions using the Brush DJ app. Research hypothesis: There was a difference in the gingival status and oral hygiene status of patients between verbal oral hygiene instructions and oral hygiene instructions using the Brush DJ app

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 Mar 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

May 2, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

Gingival indexPlaque indexFixed orthodontic applianceMobile applicationOral hygiene

Outcome Measures

Primary Outcomes (2)

  • Plaque index by Sillness and Loe

    Reduction in the mean plaque index scores

    12 weeks

  • Gingival index by Loe and Silness

    Reduction in the mean gingival index scores

    12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

This group downloads and uses Brush DJ app. Reminders are sent through this app to brush their teeth and along with this oral hygiene instructions are also given.

Behavioral: Brush DJ app

Control group

NO INTERVENTION

This group receives standard oral hygiene instructions

Interventions

Brush DJ appBEHAVIORAL

Brush DJ app is a mobile app which can be freely downloaded. This app was chosen as part of the intervention as it was recognized by the NHS to reduce the risk of gum disease and tooth decay among its users. This app was built around the info given in the public health England Delivering Better Oral Health Toolkit.

Intervention group

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • participants who have smartphones with Android version ≥ 4.0.3 or IOS version ≥ 9 operating systems
  • participants willing to comply with given oral hygiene instructions
  • participants without periodontal disease and /or dental caries at the study onset
  • participants who receive their orthodontic appliances within one year after onset of study.

You may not qualify if:

  • participants with any mental and physical disability or craniofacial disorders
  • participants with enamel or dentin dysplasia
  • participants taking medications which affects plaque accumulation such as antibiotics or antibacterial mouth rinses
  • Participants with periodontal disease or dental caries at the onset of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRDI

Kuala Lumpur, Kuala Lumpur, 57000, Malaysia

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Shilpa Gunjal, PhD

    IMU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 2, 2023

First Posted

May 10, 2023

Study Start

March 1, 2023

Primary Completion

September 30, 2023

Study Completion

October 31, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations