Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances. (PDHOI)
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: lara Zozan zozan, BDS
- Número de teléfono: +964 4240732 +9647504240732
- Correo electrónico: larazozan1990@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Muhammed Khalis Bilal, BDS
- Número de teléfono: +9647504459041
- Correo electrónico: larazozan1990@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
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. |
|
Comparador activo: 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. |
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Plaque Index (PI) from Baseline to 12 Weeks
Periodo de tiempo: 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. |
Baseline and 12 weeks after the start of the intervention.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Gingival Index (GI) from Baseline to 12 Weeks
Periodo de tiempo: Baseline and 12 weeks after the start of the intervention.
|
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. |
Baseline and 12 weeks after the start of the intervention.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: lara Zozan MIran, BDS, Kurdistan Higher Council of Medical Specialtie
Publicaciones y enlaces útiles
Enlaces Útiles
- <p>Balbaa et al. (2025) - Effectiveness of mobile oral health intervention on orthodontic patients' oral hygiene and oral health literacy: a randomized controlled clinical trial.</p>
- <p>Balbaa et al. (2025) - Mobile oral-health intervention in orthodontic patients: a randomized controlled clinical trial</p>
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1246
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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