Effectiveness of Brush DJ App in Improving Oral Hygiene Compliance of Fixed Orthodontic Patients

NCT ID: NCT05853276

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-10-31

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

Detailed Description

The participants are randomly distributed into two groups where Group I receive only standard oral hygiene instruction and Group II receive reminders via Brush DJ mobile application in addition to standard oral hygiene instructions. For the standard oral hygiene protocol received by participants of both groups, all of them are instructed to use soft-bristled toothbrushes, fluoridated toothpaste and interdental toothbrush or super floss. Proper oral hygiene education is provided to all the participants with the following 2-minute-long combined brushing technique.

For the evaluation of oral hygiene compliance of each orthodontic patient in each group, the gingival index according to Loë and Silness and Silness and Loe plaque index are measured at baseline (T0), 4th week (T1) and 8th week (T2). These indices are one of the standardized indicators of gingival health as it provides quantitative evaluation of the gingival status. GI and PI scores are measured by a single investigator who is calibrated. The reliability assessed by the intraclass correlation coefficient (ICC) suggested good agreement (0.85 & 0.88) for GI and PI respectively.

Data will be collected, cleaned, coded before doing the statistical analysis. The data will be checked for the range of Mean gingival index and Plaque index which should be within the range.

Sample size: The sample size was calculated to be 30 in each group, assuming a power of 80%, confidence interval of 95%, standard deviation (SD) of 0.5 and the aim of finding a 0.3 difference in the groups' means. All 60 volunteers were assessed for their eligibility before their participation.

Conditions

Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Brush DJ app

Intervention Type: BEHAVIORAL

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.

Control group

This group receives standard oral hygiene instructions

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brush DJ app

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. participants who have smartphones with Android version ≥ 4.0.3 or IOS version ≥ 9 operating systems

2. participants willing to comply with given oral hygiene instructions

3. participants without periodontal disease and /or dental caries at the study onset

4. participants who receive their orthodontic appliances within one year after onset of study.

Exclusion Criteria

1. participants with any mental and physical disability or craniofacial disorders

2. participants with enamel or dentin dysplasia

3. participants taking medications which affects plaque accumulation such as antibiotics or antibacterial mouth rinses

4. Participants with periodontal disease or dental caries at the onset of study.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IMU University, Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Shilpa Gunjal

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shilpa Gunjal, PhD

Role: PRINCIPAL_INVESTIGATOR

IMU

Locations

IRDI

Kuala Lumpur, Kuala Lumpur, Malaysia

Countries

Malaysia

Other Identifiers

IMU

Identifier Type: -

Identifier Source: org_study_id