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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04042389
Other study ID # RMC/EC23/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2, 2018
Est. completion date July 30, 2018

Study information

Verified date July 2019
Source Mahsa University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objective: To determine the effect of WhatsApp and Email reminders on oral hygiene compliance of orthodontic patients.

Methods: A Randomized, parallel group, double blinded study was conducted on 54 patients undergoing orthodontic treatment at MAHSA University. They were randomized to 3 groups, namely WhatsApp (W) group, Email (E) group and Control (C) group with 18 subjects in each group. Group (W) and Group (E) received oral health messages once a week through WhatsApp and E-mail reminders respectively, while Group (C) did not receive any reminders. Plaque was measured at baseline (T0), after 4 weeks (T1), and after 8 weeks (T2). For each subject, two intraoral photographs were taken after application of plaque disclosing agent; and the area covered by plaque was measured on 12, 13, 43, 22, 23 and 33 teeth by planimetry.


Description:

Fifty-four patients undergoing orthodontic treatment were recruited from the dental clinic of MAHSA University between Jan 2018 to April 2018. Voluntary written informed consent was obtained from all the subjects before the start of the study. They were randomly assigned into 3 groups namely WhatsApp (W) group, Email (E) group and Control (C) group with 18 subjects in each group. Oral hygiene messages through WhatsApp and Email were sent once a week for 8 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date July 30, 2018
Est. primary completion date April 29, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria:

- Patients having fixed maxillary and mandibular orthodontic appliances with 0.022 AO conventional metal brackets,

- Aged = 15 years,

- Undergone 3 months of orthodontic treatment,

- No significant medical or dental history

- Have access to cellular telephone and are online daily

Exclusion Criteria:

- Patients undergoing single arch treatment

- Missing maxillary lateral incisor, maxillary canine and mandibular canine

- Patients' orthodontic treatment duration < 3 months and > 4 months.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
WhatsApp reminder
The WhatsApp group received oral health messages once a week for four weeks (totaling 4 messages) as a reminder to practice good oral hygiene The reminder included an image reminding them to maintain their oral hygiene.
Email reminder
The Email group received oral health messages once a week for four weeks (totaling 4 messages) as a reminder to practice good oral hygiene The reminder included an image reminding them to maintain their oral hygiene.
Control
No messages sent.

Locations

Country Name City State
Malaysia MAHSA UNivesity Jenjarum Selangor

Sponsors (1)

Lead Sponsor Collaborator
Mahsa University

Country where clinical trial is conducted

Malaysia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in plaque from baseline to 4 weeks Plaque disclosing solution was applied to the pre-selected teeth (12,13,43, 22, 23, 33) followed by measurement of plaque using planimetry. All photographs were taken using a Canon Electro-Optical System (EOS) 550D (camera specifications). Plaque was analyzed using Image J software. Change in plaque score is assessed from baseline to 4 weeks in all the three groups.
In the photo, region of interest targeted by the study was manually outlined using "Polygon selection tool", the total pixel present in this region is calculated by tracing tool. The pixel of the plaque area is determined by adjusting the color threshold to desirable range of value. The plaque sore was calculated in the form of percent covering tooth structure and the value of plaque on each tooth was determined and mean plaque was calculated.
baseline (T0) to end of 4 weeks (T1)
Primary Change in plaque from baseline to 8 weeks Plaque disclosing solution was applied to the pre-selected teeth (12,13,43, 22, 23, 33) followed by measurement of plaque using planimetry. All photographs were taken using a Canon EOS 550D (camera specifications). Plaque was analyzed using Image J software. Change in plaque score is assessed from baseline to 8 weeks in all the three groups.
In the photo, region of interest targeted by the study was manually outlined using "Polygon selection tool", the total pixel present in this region is calculated by tracing tool. The pixel of the plaque area is determined by adjusting the color threshold to desirable range of value. The plaque sore was calculated in the form of percent covering tooth structure and the value of plaque on each tooth was determined and mean plaque was calculated.
Baseline (T0) to end of 8 weeks (T2)
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