Oral Hygiene in Patients With Fixed Orthodontic AppliancesPDHOINCT07910851
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
A study testing Personalized Digital Oral Health Education via WhatsApp and Standard Oral-Hygiene Instructions in people with Oral Hygiene in Patients With Fixed Orthodontic Appliances and Dental Plaque, run by Kurdistan Higher Council of Medical Specialties.
Trial summary
This study will evaluate whether personalized digital oral-health education delivered through WhatsApp messages can improve oral hygiene in patients aged 16-25 years who wear fixed orthodontic appliances (braces). A total of 66 participants will be assigned to two groups. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque, Gingivitis Infection
- What is being tested?
- Personalized Digital Oral Health Education via WhatsApp and Standard Oral-Hygiene Instructions
- 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
- 66 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2026to 20 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Patients wearing fixed orthodontic appliances on only one arch (maxillary or mandibular).
- Patients who do not meet the inclusion criteria.
- Patients who decline to participate.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances: a Randomized Controlled Trial
This study will evaluate whether personalized digital oral-health education delivered through WhatsApp messages can improve oral hygiene in patients aged 16-25 years who wear fixed orthodontic appliances (braces). A total of 66 participants will be assigned to two groups. The intervention group will receive weekly digital oral-health messages for 12 weeks, while the control group will receive conventional verbal oral-hygiene instructions. Both groups will receive the same antibacterial mouthwash. Oral hygiene will be assessed at the beginning of the study and after 12 weeks by measuring plaque and gingival health using the Plaque Index and Gingival Index. The findings will help determine whether digital education can support conventional oral-hygiene instructions for patients undergoing orthodontic treatment.
Read the detailed description
This randomized controlled trial will evaluate the effectiveness of a personalized digital oral-health intervention in patients aged 16-25 years undergoing treatment with fixed orthodontic appliances.
A total of 66 eligible participants will be planned for enrollment and allocation into two groups in a 1:1 ratio, with 33 participants in each group.
The intervention group will receive weekly oral-health educational and motivational messages through WhatsApp over 12 weeks. The messages will address oral-hygiene practices during orthodontic treatment, including toothbrushing around fixed appliances, interdental cleaning, plaque control, gingival health, dietary habits, prevention of white spot lesions, and maintenance of oral hygiene.
The control group will receive conventional verbal oral-hygiene instructions. Both groups will receive the same alcohol-free antibacterial mouthwash to maintain consistency in this aspect of oral-hygiene care.
Clinical assessments will be conducted at baseline and after 12 weeks. Oral hygiene outcomes will be assessed using the Plaque Index and Gingival Index. The changes in these indices between the two assessment time points will be compared between the intervention and control groups.
The study is planned to recruit participants from dental centers in Erbil, Kurdistan Region, Iraq. Participation will be voluntary, and informed consent will be obtained before enrollment. For participants younger than 18 years, parental or guardian consent and participant assent will be obtained as applicable.
The findings are expected to provide evidence on whether digital oral-health education can support conventional oral-hygiene instructions for patients receiving fixed orthodontic treatment.
- Conditions
- Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque, Gingivitis Infection
- Being tested
- Personalized Digital Oral Health Education via WhatsApp, Standard Oral-Hygiene Instructions
- Keywords
- Oral hygiene, Fixed orthodontic appliances, Digital oral health intervention, Plaque Index, Gingival Index, WhatsApp, Randomized controlled trial
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Digital Oral Health Education via WhatsAppBehavioural
A 12-week digital oral-health education intervention delivered through WhatsApp to patients undergoing fixed orthodontic treatment. Participants receive one oral-health message per week covering oral hygiene awareness, motivation, and practical instructions for maintaining oral hygiene around orthodontic appliances. Topics include toothbrushing techniques, interdental cleaning, gingival health, plaque control, dietary advice, prevention of white spot lesions, and orthodontic appliance care. The intervention is provided in addition to conventional verbal oral-hygiene instructions and the study-provided antibacterial mouthwash.
Standard Oral-Hygiene InstructionsBehavioural
Conventional verbal oral-hygiene instructions provided to participants in the control group. Participants do not receive additional oral-health messages through WhatsApp during the 12-week study period.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Digital Oral Health Intervention | Experimental | Participants will receive conventional verbal oral-hygiene instructions and the same study-provided antibacterial mouthwash as the control group. In addition, participants will receive weekly personalized digital oral-health messages through WhatsApp for 12 weeks. The messages will provide oral-hygiene education, motivation, and practical instructions for maintaining oral hygiene during fixed orthodontic treatment. Receives: Behavioral: Personalized Digital Oral Health Education via WhatsApp |
| Standard Oral-Hygiene Instruction Group | Active comparator | Participants will receive conventional verbal oral-hygiene instructions and the same study-provided antibacterial mouthwash as the experimental group. They will not receive additional oral-health messages through WhatsApp during the 12-week study period. Receives: Behavioral: Standard Oral-Hygiene Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plaque Index (PI) from Baseline to 12 Weeks
Plaque will be assessed using the Silness and Löe Plaque Index. Scores range from 0 to 3, with higher scores indicating greater plaque accumulation and poorer oral hygiene. The change in score will be assessed between baseline and 12 weeks.
Measured: Baseline and 12 weeks after the start of the intervention.
Secondary outcomes (1)
Change in Gingival Index (GI) from Baseline to 12 Weeks
Gingival inflammation will be assessed using the Löe and Silness Gingival Index. Scores range from 0 to 3, with higher scores indicating greater gingival inflammation and poorer gingival health. The change in score will be assessed between baseline and 12 weeks.
Measured: Baseline and 12 weeks after the start of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start20 Nov 2026 (estimated)
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Hygiene in Patients With Fixed Orthodontic AppliancesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kurdistan Higher Council of Medical Specialties
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Zozan Jamil Miran, Kurdistan Higher Council of Medical Specialties
- Investigators
- lara Zozan MIran, BDS, Principal investigator, Kurdistan Higher Council of Medical Specialtie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910851
- Sponsor's protocol ID
- 1246
- Acronym
- PDHOI
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding sharing individual participant data (IPD) has not yet been made. Any future decision will consider participant confidentiality, data privacy, ethical requirements, and applicable institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07910851
- Acronym / sponsor ID
- PDHOI / 1246
- Conditions
- Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque, Gingivitis Infection
- Keywords
- Oral hygiene, Fixed orthodontic appliances, Digital oral health intervention, Plaque Index, Gingival Index, WhatsApp, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Kurdistan Higher Council of Medical SpecialtiesUniversity, hospital or other
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Jun 2027 (estimated)
- First posted
- 2 Nov 2026 (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.
This study will evaluate whether personalized digital oral-health education delivered through WhatsApp messages can improve oral hygiene in patients aged 16-25 years who wear fixed orthodontic appliances (braces). A total of 66 participants will be assigned to two groups. The intervention group will receive weekly digital oral-health messages for 12 weeks, while the control group will receive conventional verbal oral-hygiene instructions. Both groups will receive the same antibacterial mouthwash. Oral hygiene will be assessed at the beginning of the study and after 12 weeks by measuring plaque and gingival health using the Plaque Index and Gingival Index. The findings will help determine whether digital education can support conventional oral-hygiene instructions for patients undergoing orthodontic treatment.
Detailed description
This randomized controlled trial will evaluate the effectiveness of a personalized digital oral-health intervention in patients aged 16-25 years undergoing treatment with fixed orthodontic appliances.
A total of 66 eligible participants will be planned for enrollment and allocation into two groups in a 1:1 ratio, with 33 participants in each group.
The intervention group will receive weekly oral-health educational and motivational messages through WhatsApp over 12 weeks. The messages will address oral-hygiene practices during orthodontic treatment, including toothbrushing around fixed appliances, interdental cleaning, plaque control, gingival health, dietary habits, prevention of white spot lesions, and maintenance of oral hygiene.
The control group will receive conventional verbal oral-hygiene instructions. Both groups will receive the same alcohol-free antibacterial mouthwash to maintain consistency in this aspect of oral-hygiene care.
Clinical assessments will be conducted at baseline and after 12 weeks. Oral hygiene outcomes will be assessed using the Plaque Index and Gingival Index. The changes in these indices between the two assessment time points will be compared between the intervention and control groups.
The study is planned to recruit participants from dental centers in Erbil, Kurdistan Region, Iraq. Participation will be voluntary, and informed consent will be obtained before enrollment. For participants younger than 18 years, parental or guardian consent and participant assent will be obtained as applicable.
The findings are expected to provide evidence on whether digital oral-health education can support conventional oral-hygiene instructions for patients receiving fixed orthodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Digital Oral Health Intervention | Experimental | Behavioral: Personalized Digital Oral Health Education via WhatsAppParticipants will receive conventional verbal oral-hygiene instructions and the same study-provided antibacterial mouthwash as the control group. In addition, participants will receive weekly personalized digital oral-health messages through WhatsApp for 12 weeks. The messages will provide oral-hygiene education, motivation, and practical instructions for maintaining oral hygiene during fixed orthodontic treatment. |
| Standard Oral-Hygiene Instruction Group | Active comparator | Behavioral: Standard Oral-Hygiene InstructionsParticipants will receive conventional verbal oral-hygiene instructions and the same study-provided antibacterial mouthwash as the experimental group. They will not receive additional oral-health messages through WhatsApp during the 12-week study period. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patients wearing fixed orthodontic appliances on only one arch (maxillary or mandibular).
- Patients who do not meet the inclusion criteria.
- Patients who decline to participate.
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 |
|---|---|---|
| Personalized Digital Oral Health Education via WhatsAppA 12-week digital oral-health education intervention delivered through WhatsApp to patients undergoing fixed orthodontic treatment. Participants receive one oral-health message per week covering oral hygiene awareness, motivation, and practical instructions for maintaining oral hygiene around orthodontic appliances. Topics include toothbrushing techniques, interdental cleaning, gingival health, plaque control, dietary advice, prevention of white spot lesions, and orthodontic appliance care. The intervention is provided in addition to conventional verbal oral-hygiene instructions and the study-provided antibacterial mouthwash. | Behavioural | Personalized Digital Oral Health Intervention |
| Standard Oral-Hygiene InstructionsConventional verbal oral-hygiene instructions provided to participants in the control group. Participants do not receive additional oral-health messages through WhatsApp during the 12-week study period. | Behavioural | Standard Oral-Hygiene Instruction Group |
Primary outcome
Change in Plaque Index (PI) from Baseline to 12 Weeks
Time frame: Baseline and 12 weeks after the start of the intervention.
Plaque will be assessed using the Silness and Löe Plaque Index. Scores range from 0 to 3, with higher scores indicating greater plaque accumulation and poorer oral hygiene. The change in score will be assessed between baseline and 12 weeks.
1 secondary outcome
Change in Gingival Index (GI) from Baseline to 12 Weeks
Time frame: Baseline and 12 weeks after the start of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Balbaa et al. (2025) - Effectiveness of mobile oral health intervention on orthodontic patients' oral hygiene and oral health literacy: a randomized controlled clinical trial.Link provided by the sponsor.
- Balbaa et al. (2025) - Mobile oral-health intervention in orthodontic patients: a randomized controlled clinical trialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. The decision regarding sharing individual participant data (IPD) has not yet been made. Any future decision will consider participant confidentiality, data privacy, ethical requirements, and applicable institutional policies.
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Enrolling by invitationObservational study
Efficacy and Safety of the "Neo Pill" Device for Keeping Oral Hygiene in Patients with Fixed Orthodontic Appliance
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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.
lara Zozan MIran, BDS principal investigator
Kurdistan Higher Council of Medical Specialtie
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Digital Oral Health Education via WhatsApp and Standard Oral-Hygiene Instructions in people with Oral Hygiene in Patients With Fixed Orthodontic Appliances and Dental Plaque, run by Kurdistan Higher Council of Medical Specialties.
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 0 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact lara Zozan zozan, BDS (+9647504240732 ext. +964 4240732, larazozan1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Plaque Index (PI) from Baseline to 12 Weeks (time frame: Baseline and 12 weeks after the start of the intervention.). 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 3 Nov 2026.