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OpenTrials
Completed

NCT Number: NCT05853276

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

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

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Key information

Conditions

Gingivitis Gingival Diseases Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRDI

Kuala Lumpur, 57000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brush DJ app

Behavioral

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 outcomes

  1. Plaque index by Sillness and Loe

    Time frame: 12 weeks

    Reduction in the mean plaque index scores

  2. Gingival index by Loe and Silness

    Time frame: 12 weeks

    Reduction in the mean gingival index scores

Sponsors and collaborators

Lead sponsor

IMU University, Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 10, 2023
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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