Clinical trial NCT05853276: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: Gingival index
Plaque index
Fixed orthodontic appliance
Mobile application
Oral hygiene
Lead sponsor: International Medical University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Plaque index by Sillness and Loe
timeFrame: 12 weeks
measure: Gingival index by Loe and Silness
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: IRDI
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: IMU
name: Shilpa Gunjal, PhD
role: PRINCIPAL_INVESTIGATOR
References: