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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05853276
Other study ID # IMU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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