search
Back to results

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

Primary Purpose

Gingivitis

Status
Active
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Brush DJ app
Sponsored by
International Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gingivitis focused on measuring Gingival index, Plaque index, Fixed orthodontic appliance, Mobile application, Oral hygiene

Eligibility Criteria

15 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • IRDI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

This group receives standard oral hygiene instructions

Outcomes

Primary Outcome Measures

Plaque index by Sillness and Loe
Reduction in the mean plaque index scores
Gingival index by Loe and Silness
Reduction in the mean gingival index scores

Secondary Outcome Measures

Full Information

First Posted
May 2, 2023
Last Updated
September 26, 2023
Sponsor
International Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05853276
Brief Title
Effectiveness of Brush DJ App in Improving Oral Hygiene Compliance of Fixed Orthodontic Patients
Official Title
Effectiveness of Brush DJ App to Improve Oral Hygiene Compliance in Patients With Fixed Orthodontic Appliances - Randomised Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
Gingival index, Plaque index, Fixed orthodontic appliance, Mobile application, Oral hygiene

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group receives standard oral hygiene instructions
Intervention Type
Behavioral
Intervention Name(s)
Brush DJ app
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plaque index by Sillness and Loe
Description
Reduction in the mean plaque index scores
Time Frame
12 weeks
Title
Gingival index by Loe and Silness
Description
Reduction in the mean gingival index scores
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shilpa Gunjal, PhD
Organizational Affiliation
IMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRDI
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
57000
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs