ClinicalTrials.gg
Not yet recruitingNCT07910851PDHOIUpdated Nov 3, 2026

Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.

An interventional study of Personalized Digital Oral Health Education via WhatsApp and Standard Oral-Hygiene Instructions in Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque and Gingivitis Infection, sponsored by Kurdistan Higher Council of Medical Specialties. Not yet recruiting. Open to participants aged 16 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Kurdistan Higher Council of Medical Specialties · Not applicable, Interventional, and Treatment

Updated Nov 3, 2026Eligibility revisedPrimary outcomes revised+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
16 Years to 25 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Oral Hygiene in Patients With Fixed Orthodontic Appliances
  • Dental Plaque
  • Gingivitis Infection

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Keywords

  • Oral hygiene
  • Fixed orthodontic appliances
  • Digital oral health intervention
  • Plaque Index
  • Gingival Index
  • WhatsApp
  • Randomized controlled trial
03

In context

Dental Plaque

352 studies on the registry are indexed under Dental Plaque; 60 are open to participants now.

This study's planned enrollment of 66 is above the median of 56 across 316 interventional studies indexed under Dental Plaque.

Browse Dental Plaque studies →

Lead sponsor

Kurdistan Higher Council of Medical Specialties is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 3, 2026. See what changed

Ages eligible
16 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

IInclusion Criteria:

Patients aged 16-25 years.

Patients wearing fixed orthodontic appliances on both the maxillary and mandibular arches.

Patients who agree to participate in the study.

Exclusion Criteria:

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Personalized Digital Oral Health Intervention

    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.

    Behavioral: Personalized Digital Oral Health Education via WhatsApp

  • Active comparator
    Standard Oral-Hygiene Instruction Group

    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.

    Behavioral: Standard Oral-Hygiene Instructions

Interventions

  • BehavioralPersonalized Digital Oral Health Education via WhatsApp

    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.

  • BehavioralStandard Oral-Hygiene Instructions

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline and 12 weeks after the start of the intervention.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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.

09

Updates

2 registry updates since Sep 25, 2026
Eligibility
Criteria largely rewritten (19 changes)
What changed in the criteria
  • AddedIInclusion Criteria:
  • EditedInclusion Criteria:Patients aged 16-25 years.
  • RemovedPatients undergoing fixed orthodontic treatment for at least 6 months.
  • RemovedPatients who can use a smartphone and receive WhatsApp messages.
  • AddedPatients wearing fixed orthodontic appliances on both the maxillary and mandibular arches.
  • EditedPatients who use other mouthwashes and are unwillingagree to discontinue them duringparticipate in the study.
  • RemovedPatients unable or unwilling to complete the 12-week follow-up assessments.
  • RemovedPatients with poor orthodontic follow-up compliance, according to the study's predefined eligibility criteria.
  • Removed-
  • AddedExclusion Criteria:
  • AddedPatients wearing fixed orthodontic appliances on only one arch (maxillary or mandibular).
  • AddedPatients who do not meet the inclusion criteria.
  • EditedPatients willingwho decline to participate and provide informed consent.
  • RemovedPatients willing to attend the baseline and 12-week follow-up assessments.
  • RemovedPatients willing to use the study-provided antibacterial mouthwash and follow the study instructions.
  • Removed-
  • RemovedExclusion Criteria:Patients with systemic conditions that may affect oral or gingival health.
  • RemovedPatients with a known allergy or sensitivity to the study-provided mouthwash.
  • RemovedPatients who have used antibiotics or antimicrobial mouthwash during the 4 weeks before baseline assessment.
Nov 3, 2026
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionChange in Plaque Index (PI) from Baseline to 12 Weeks: how it is measured was reworded
Nov 3, 2026
Secondary outcomes
1 description edited
What changed in the outcomes
  • DescriptionChange in Gingival Index (GI) from Baseline to 12 Weeks: how it is measured was reworded
Nov 3, 2026
Title
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances: a Randomized Controlled Trial.
Nov 3, 2026
Registered
First appeared on the registry
Nov 2, 2026
Show all 2 updates
  1. Nov 3, 2026
    Eligibility Criteria largely rewritten (19 changes)
    What changed in the criteria
    • AddedIInclusion Criteria:
    • EditedInclusion Criteria:Patients aged 16-25 years.
    • RemovedPatients undergoing fixed orthodontic treatment for at least 6 months.
    • RemovedPatients who can use a smartphone and receive WhatsApp messages.
    • AddedPatients wearing fixed orthodontic appliances on both the maxillary and mandibular arches.
    • EditedPatients who use other mouthwashes and are unwillingagree to discontinue them duringparticipate in the study.
    • RemovedPatients unable or unwilling to complete the 12-week follow-up assessments.
    • RemovedPatients with poor orthodontic follow-up compliance, according to the study's predefined eligibility criteria.
    • Removed-
    • AddedExclusion Criteria:
    • AddedPatients wearing fixed orthodontic appliances on only one arch (maxillary or mandibular).
    • AddedPatients who do not meet the inclusion criteria.
    • EditedPatients willingwho decline to participate and provide informed consent.
    • RemovedPatients willing to attend the baseline and 12-week follow-up assessments.
    • RemovedPatients willing to use the study-provided antibacterial mouthwash and follow the study instructions.
    • Removed-
    • RemovedExclusion Criteria:Patients with systemic conditions that may affect oral or gingival health.
    • RemovedPatients with a known allergy or sensitivity to the study-provided mouthwash.
    • RemovedPatients who have used antibiotics or antimicrobial mouthwash during the 4 weeks before baseline assessment.
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionChange in Plaque Index (PI) from Baseline to 12 Weeks: how it is measured was reworded
    Secondary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionChange in Gingival Index (GI) from Baseline to 12 Weeks: how it is measured was reworded
    Title Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances: a Randomized Controlled Trial.
    + 2 other changes: index terms and conditions
  2. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07910851
Lead sponsor
Kurdistan Higher Council of Medical Specialties
Responsible party
Lara Zozan Jamil Miran (Effectiveness of personalized digital oral health intervention in patients with fixed orthodontic appliances: a Randomized controlled trial, Kurdistan Higher Council of Medical Specialties) — Principal investigator
First posted
Nov 2, 2026
Start date
Nov 20, 2026 (estimated)
Primary completion
Jan 20, 2027 (estimated)
Completion
Jun 20, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

lara Zozan zozan, BDS
Contact
larazozan1990@gmail.com
+9647504240732 ext. +964 4240732
Muhammed Khalis Bilal, BDS
Contact
larazozan1990@gmail.com
+9647504459041
lara Zozan MIran, BDS
principal investigator · Kurdistan Higher Council of Medical Specialtie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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