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

Gingivitis Clinical Trial

Official title:

Effectiveness of Brush DJ App to Improve Oral Hygiene Compliance in Patients With Fixed Orthodontic Appliances - Randomised Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05853276
• Other study ID #: IMU
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2024
• Source: International Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Malaysia	IRDI	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
International Medical University

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque index by Sillness and Loe	Reduction in the mean plaque index scores	12 weeks
Primary	Gingival index by Loe and Silness	Reduction in the mean gingival index scores	12 weeks