NCT04042389

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
Last Updated

August 1, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

July 28, 2019

Last Update Submit

July 31, 2019

Conditions

Keywords

WhatsAppEmailOral hygieneComplianceOrthodonticsPlanimetryReminders

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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)

Study Arms (3)

WhatsApp

EXPERIMENTAL

WhatsApp reminders

Behavioral: WhatsApp reminder

Email

EXPERIMENTAL

Email reminders

Behavioral: Email reminder

Control

OTHER

No reminder

Behavioral: Control

Interventions

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.

Also known as: Reminders
WhatsApp
Email reminderBEHAVIORAL

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.

Also known as: Reminder
Email
ControlBEHAVIORAL

No messages sent.

Control

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients undergoing single arch treatment
  • Missing maxillary lateral incisor, maxillary canine and mandibular canine
  • Patients' orthodontic treatment duration \< 3 months and \> 4 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MAHSA UNivesity

Jenjarum, Selangor, 42610, Malaysia

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Kirti Saxena, MDS

    Mahsa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 28, 2019

First Posted

August 1, 2019

Study Start

January 2, 2018

Primary Completion

April 29, 2018

Study Completion

July 30, 2018

Last Updated

August 1, 2019

Record last verified: 2019-07

Locations