Compliance, TreatmentNCT04042389
Oral Hygiene Reminders in Orthodontic Patients
A study testing WhatsApp reminder and Email reminder in people with Compliance, Treatment, run by Mahsa University at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Compliance, Treatment
- What is being tested?
- WhatsApp reminder and Email reminder
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Jan 2018to 30 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients undergoing single arch treatment
- Missing maxillary lateral incisor, maxillary canine and mandibular canine
- Patients' orthodontic treatment duration < 3 months and > 4 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed 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.
- Conditions
- Compliance, Treatment
- Being tested
- WhatsApp reminder, Email reminder, Control
- Keywords
- WhatsApp, Email, Oral hygiene, Compliance, Orthodontics, Planimetry, Reminders
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WhatsApp reminderBehavioural
Also called 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.
Email reminderBehavioural
Also called 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.
ControlBehavioural
No messages sent.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | WhatsApp reminders Receives: Behavioral: WhatsApp reminder | |
| Experimental | Email reminders Receives: Behavioral: Email reminder | |
| Control | Other | No reminder Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (T0) to end of 8 weeks (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start2 Jan 2018
- Primary completion29 Apr 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compliance, TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahsa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirti Saxena, Mahsa University
- Investigators
- Kirti Saxena, MDS, Principal investigator, Mahsa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042389
- Sponsor's protocol ID
- RMC/EC23/2017
- Status last verified
- Jul 2019
- First submitted
- 28 Jul 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of WhatsApp and Electronic Mail Reminders on Oral Hygiene Compliance of Orthodontic Patients Using Planimetry
- ClinicalTrials.gov ID
- NCT04042389
- Acronym / sponsor ID
- RMC/EC23/2017
- Conditions
- Compliance, Treatment
- Keywords
- WhatsApp, Email, Oral hygiene, Compliance, Orthodontics, Planimetry, Reminders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mahsa UniversityUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 29 Apr 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental | Behavioral: WhatsApp reminderWhatsApp reminders | |
| Experimental | Behavioral: Email reminderEmail reminders | |
| Control | Other | Behavioral: ControlNo reminder |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Patients undergoing single arch treatment
- Missing maxillary lateral incisor, maxillary canine and mandibular canine
- Patients' orthodontic treatment duration < 3 months and > 4 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WhatsApp reminderAlso: RemindersThe 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. | Behavioural | |
| Email reminderAlso: ReminderThe 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. | Behavioural | |
| ControlNo messages sent. | Behavioural | Control |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirti Saxena, MDS principal investigator
Mahsa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WhatsApp reminder and Email reminder in people with Compliance, Treatment, run by Mahsa University at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plaque from baseline to 4 weeks (time frame: baseline (T0) to end of 4 weeks (T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.