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

Sponsor

International Medical University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05853276

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Gingivitis	Behavioral: Brush DJ app	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.
No Intervention: Control group This group receives standard oral hygiene instructions

Arm

Intervention/Treatment

Experimental: 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.

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.

No Intervention: Control group

This group receives standard oral hygiene instructions

Outcome Measures

Primary Outcome Measures

Plaque index by Sillness and Loe [12 weeks]
Reduction in the mean plaque index scores
Gingival index by Loe and Silness [12 weeks]
Reduction in the mean gingival index scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.