Oral HygieneNCT06080321
Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders
A study testing WhatsApp reminders, Instagram reminders and Phone calls in people with Oral Hygiene and Dental Plaque, run by Nourhan M.Aly at 1 site in Egypt.
Trial summary
The aim of the present study will be to determine if different forms of active reminders regarding oral hygiene compliance have an influence on the level of compliance within orthodontic patients Read more about this study
- Who is it for?
- Ages 11 to 20 years
- Conditions the study is for
- Oral Hygiene, Dental Plaque
- What is being tested?
- WhatsApp reminders, Instagram reminders and Phone calls
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to Apr 2024
- 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 11 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects with a complete natural dentition.
- Patients who need to undergo orthodontic therapy using fixed appliances.
- Good oral hygiene, with no signs and symptoms of periodontal disease.
- Patients with no medical or mental problems.
Who cannot join
- Patients with health risks associated with periodontal probing.
- Syndromic patients ex; Down syndrome.
- Previous orthodontic treatment.
- Patients with carious teeth
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Alexandria University
Alexandria, 21512
Nourhan M Aly, BDS, (03) 4868308, nourhan.moustafa@alexu.edu.eg
Samar M Adel, PhD
About this study
Official title: Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders: A Randomized Controlled Clinical Trial
The aim of the present study will be to determine if different forms of active reminders regarding oral hygiene compliance have an influence on the level of compliance within orthodontic patients
- Conditions
- Oral Hygiene, Dental Plaque
- Being tested
- WhatsApp reminders, Instagram reminders, Phone calls, Application alerts
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WhatsApp remindersOther
Patients will receive active oral hygiene reminders in the form of WhatsApp messages one weekday each week. The standardized text message will be: "This is a message from the Orthodontic Clinic at Faculty of Dentistry, Alexandria reminding you that it is extremely important to brush your teeth for 2 minutes after every meal or at least 3 times daily. Cleaning your teeth will help to keep them healthy and beautiful."
Instagram remindersOther
Patients will receive active oral hygiene reminders in the form of Instagram messages one weekday each week. The standardized text message will be: "This is a message from the Orthodontic Clinic at Faculty of Dentistry, Alexandria reminding you that it is extremely important to brush your teeth for 2 minutes after every meal or at least 3 times daily. Cleaning your teeth will help to keep them healthy and beautiful."
Phone callsOther
Patients will receive active oral hygiene reminders in the form of phone calls one weekday each week. The structured phone call will be: "This is a message from the Orthodontic Clinic at Faculty of Dentistry, Alexandria reminding you that it is extremely important to brush your teeth for 2 minutes after every meal or at least 3 times daily. Cleaning your teeth will help to keep them healthy and beautiful."
Application alertsOther
Patients will download an app on their mobile phones which has cleaning tips, demonstrations and alerts. The structured message will be: "This is a message from the Orthodontic Clinic at Faculty of Dentistry, Alexandria reminding you that it is extremely important to brush your teeth for 2 minutes after every meal or at least 3 times daily. Cleaning your teeth will help to keep them healthy and beautiful."
| Study group | Role | What they receive |
|---|---|---|
| WhatsApp messages | Experimental | Not described Receives: Other: WhatsApp reminders |
| Instagram messages | Experimental | Not described Receives: Other: Instagram reminders |
| Phone calls | Experimental | Not described Receives: Other: Phone calls |
| App alerts | Active comparator | Not described Receives: Other: Application alerts |
| No active reminders | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival bleeding
This will be assessed using the bleeding index (BI) upon probing the mesio-buccal, direct buccal, and disto-buccal aspects of the gingival sulci of the teeth. BI scoring ranges from 0-2; 0: no bleeding after 30 seconds, 1: bleeding after 30 seconds, 2: immediate bleeding
Measured: up to 6 months
Gingival inflammation
This will be assessed using the modified gingival index (MGI). One MGI measurement of the buccal marginal gingiva for each tooth will be scored. Scoring ranges from 0-4 where 0 indicates absence of inflammation, 1: mild inflammation (marginal or papillary unit), 2: mild inflammation (entire marginal and papillary unit), 3: moderate inflammation, and 4: severe inflammation
Measured: up to 6 months
Plaque accumulation
This will be assessed using the plaque index (PI). One PI measurement will be recorded for the buccal surface of each tooth. Scoring ranges from 0-5; where 0 indicates absence of plaque, 1: discontinuous plaque band at gingival margin, 2: up to 1 mm continuous plaque band at gingival margin, 3: plaque band wider than 1 mm but less than 1/3 of the surface, 4: plaque band between 1/3 and 2/3 of the surface, and 5: plaque covering 2/3 or more of the surface
Measured: up to 6 months
Visual examination of white spot lesions
The presence of white spot lesions located on the buccal surface gingival to the archwire will be examined visually on the maxillary and mandibular six anterior teeth after being air dried for 5 seconds. Scoring ranges from 0-3; where 0: no visible white spot or surface disruption, 1: visible white spot without surface disruption, 2: visible white spot with roughened surface, 3: visible white spot requiring restoration.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Oct 2023
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Samar M Adel, PhD, Principal investigator, Alexandria UniversityNikhilesh R Vaid, PhD, Study chair, Department of Orthodontics, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, IndiaEiman Marzouk, PhD, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080321
- Sponsor's protocol ID
- #9/2023
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Hygiene Compliance in Orthodontic Patients Using Active Reminders: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06080321
- Acronym / sponsor ID
- #9/2023
- Conditions
- Oral Hygiene, Dental Plaque
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 12 Oct 2023 (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.
The aim of the present study will be to determine if different forms of active reminders regarding oral hygiene compliance have an influence on the level of compliance within orthodontic patients
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| WhatsApp messages | Experimental | Other: WhatsApp reminders |
| Instagram messages | Experimental | Other: Instagram reminders |
| Phone calls | Experimental | Other: Phone calls |
| App alerts | Active comparator | Other: Application alerts |
| No active reminders | No intervention | – |
Who may qualify
- Ages
- 11 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Subjects with a complete natural dentition.
- Patients who need to undergo orthodontic therapy using fixed appliances.
- Good oral hygiene, with no signs and symptoms of periodontal disease.
- Patients with no medical or mental problems.
Key exclusion criteria (4 listed)
- Patients with health risks associated with periodontal probing.
- Syndromic patients ex; Down syndrome.
- Previous orthodontic treatment.
- Patients with carious teeth
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 remindersPatients will receive active oral hygiene reminders in the form of WhatsApp messages one weekday each week. The standardized text message will be: "This is a message from the Orthodontic Clinic at Faculty of Dentistry, Alexandria reminding you that it is extremely important to brush your teeth for 2 minutes after every meal or at least 3 times daily. Cleaning your teeth will help to keep them healthy and beautiful." | Other | WhatsApp messages |
| Instagram remindersPatients will receive active oral hygiene reminders in the form of Instagram messages one weekday each week. The standardized text message will be: "This is a message from the Orthodontic Clinic at Faculty of Dentistry, Alexandria reminding you that it is extremely important to brush your teeth for 2 minutes after every meal or at least 3 times daily. Cleaning your teeth will help to keep them healthy and beautiful." | Other | Instagram messages |
| Phone callsPatients will receive active oral hygiene reminders in the form of phone calls one weekday each week. The structured phone call will be: "This is a message from the Orthodontic Clinic at Faculty of Dentistry, Alexandria reminding you that it is extremely important to brush your teeth for 2 minutes after every meal or at least 3 times daily. Cleaning your teeth will help to keep them healthy and beautiful." | Other | Phone calls |
| Application alertsPatients will download an app on their mobile phones which has cleaning tips, demonstrations and alerts. The structured message will be: "This is a message from the Orthodontic Clinic at Faculty of Dentistry, Alexandria reminding you that it is extremely important to brush your teeth for 2 minutes after every meal or at least 3 times daily. Cleaning your teeth will help to keep them healthy and beautiful." | Other | App alerts |
Primary outcome
Gingival bleeding
Time frame: up to 6 months
This will be assessed using the bleeding index (BI) upon probing the mesio-buccal, direct buccal, and disto-buccal aspects of the gingival sulci of the teeth. BI scoring ranges from 0-2; 0: no bleeding after 30 seconds, 1: bleeding after 30 seconds, 2: immediate bleeding
Gingival inflammation
Time frame: up to 6 months
This will be assessed using the modified gingival index (MGI). One MGI measurement of the buccal marginal gingiva for each tooth will be scored. Scoring ranges from 0-4 where 0 indicates absence of inflammation, 1: mild inflammation (marginal or papillary unit), 2: mild inflammation (entire marginal and papillary unit), 3: moderate inflammation, and 4: severe inflammation
Plaque accumulation
Time frame: up to 6 months
This will be assessed using the plaque index (PI). One PI measurement will be recorded for the buccal surface of each tooth. Scoring ranges from 0-5; where 0 indicates absence of plaque, 1: discontinuous plaque band at gingival margin, 2: up to 1 mm continuous plaque band at gingival margin, 3: plaque band wider than 1 mm but less than 1/3 of the surface, 4: plaque band between 1/3 and 2/3 of the surface, and 5: plaque covering 2/3 or more of the surface
Visual examination of white spot lesions
Time frame: up to 6 months
The presence of white spot lesions located on the buccal surface gingival to the archwire will be examined visually on the maxillary and mandibular six anterior teeth after being air dried for 5 seconds. Scoring ranges from 0-3; where 0: no visible white spot or surface disruption, 1: visible white spot without surface disruption, 2: visible white spot with roughened surface, 3: visible white spot requiring restoration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
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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.
Samar M Adel, PhD principal investigator
Alexandria University
Nikhilesh R Vaid, PhD study chair
Department of Orthodontics, Saveetha Dental College, Saveetha Institute of Medical and Technical Sciences, Chennai, India
Eiman Marzouk, PhD study director
Alexandria 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 reminders, Instagram reminders and Phone calls in people with Oral Hygiene and Dental Plaque, run by Nourhan M.Aly at 1 site in Egypt.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 12 Oct 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar M Adel, PhD (1099911526 ext. +20, orthosamar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival bleeding (time frame: up to 6 months). The study lists 4 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 12 Oct 2023.