- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04042389
Oral Hygiene Reminders in Orthodontic Patients
Influence of WhatsApp and Electronic Mail Reminders on Oral Hygiene Compliance of Orthodontic Patients Using Planimetry
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selangor
-
Jenjarum, Selangor, Malaysia, 42610
- MAHSA UNivesity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: WhatsApp
WhatsApp reminders
|
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.
Other Names:
|
EXPERIMENTAL: Email
Email reminders
|
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.
Other Names:
|
OTHER: Control
No reminder
|
No messages sent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plaque from baseline to 4 weeks
Time Frame: baseline (T0) to end of 4 weeks (T1)
|
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)
|
Change in plaque from baseline to 8 weeks
Time Frame: Baseline (T0) to end of 8 weeks (T2)
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kirti Saxena, MDS, Mahsa University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RMC/EC23/2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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