Evaluating Methods of Dental Health Instructions on the Oral Health Indices of 12-18-year-old Patients With Fixed Orthodontics
Evaluating Methods of Dental Health Instructions on the Oral Health Indices of 12-18-year-old Patients With Fixed Orthodontics Referring to the Orthodontic Department and Clinic of Tehran University of Medical Sciences, A Randomized Clinical Trial
The goal of this clinical trial is to learn which type of oral health education works best to help 12-18-year-old participants with fixed orthodontic appliances (braces) keep their mouths healthy. The main questions it aims to answer are:
Which method of oral hygiene instruction-video-based, written, or face-to-face education-is most effective in improving oral health?
Do these education methods help lower dental plaque and gum inflammation during orthodontic treatment?
Researchers will compare the three groups of participants who receive different types of oral hygiene training to see which method leads to the best oral health results.
Participants will:
Receive one of three types of oral hygiene instruction (video, written, or in-person).
Continue their regular orthodontic care and brushing routine.
Have their oral health checked at different times during the study to measure changes in plaque and gum health.
The study hopes to identify the most effective and practical way to teach young orthodontic patients to keep their teeth and gums healthy while wearing braces.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Tehran, Irán, 1439955991
- Faculty of Dentistry, Tehran University of Medical Sciences
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients with fixed orthodontics aged 12 to 18 years
- Patient cooperation to participate in the study and follow-up
- Patients with no history of systemic and mental illnesses and no use of neuropsychiatric medications
- Patients who are not participating in another study related to oral health
- Patients who do not have caries or periodontal problems at the beginning of orthodontic treatment (GI, PI, and BOP indices are less than 10%)
- Patients whose brackets have been placed by an orthodontist (specialized department and special clinic) and under the bonding principles mentioned in the text books.
Exclusion Criteria:
- Patients who are not cooperative.
- Patients with systemic diseases and cleft palate and syndromes affecting the study results and health indicators.
- Patients with caries or periodontal problems with significant Clinical Attachment Loss (GI, PI and BOP indices are more than 10%)
- Patients using medications that affect plaque adhesion, such as mouthwashes
- Patients with a history of long-term antibiotic use
- Smokers
- Patients with dental anomalies
- Patients with mental and physical problems that prevent oral hygiene
- Patients with dental impaction
- Patients with a treatment plan that includes extraoral appliances
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Face-to-face Oral Hygiene Instruction
Participants receive traditional chairside oral hygiene instruction delivered verbally by a trained dentist or oral health educator.
Instructions include proper toothbrushing technique, use of fluoride toothpaste, interdental cleaning, and care of orthodontic appliances.
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Participants receive standardized oral hygiene instruction delivered verbally by a trained dental professional at baseline.
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Experimental: Video-Based Oral Hygiene Instruction
Participants receive oral hygiene instruction using a video and visual demonstration on toothbrushing, interdental cleaning, and care of orthodontic appliances.
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Participants view a standardized educational video demonstrating proper toothbrushing, interdental cleaning, and care for fixed orthodontic appliances.
The video includes animations and real-life demonstrations to ensure consistent delivery of information.
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Experimental: Pamphlet-based Oral Hygiene Instruction
Participants receive oral hygiene instruction through a printed educational pamphlet containing text and illustrations about proper toothbrushing technique, interdental cleaning, use of fluoride toothpaste, and care of orthodontic appliances.
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Participants receive a standardized printed pamphlet containing text and illustrations about proper toothbrushing technique, interdental cleaning, fluoride toothpaste use, and maintenance of fixed orthodontic appliances
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Plaque Index (PI)
Periodo de tiempo: Baseline and 4 weeks after intervention
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The Plaque Index (PI) will be measured using the Silness and Löe method to assess the level of dental plaque accumulation.
The outcome represents the change in PI scores from baseline to 4-week follow-up among participants in the three intervention groups (verbal, pamphlet, video).
Lower scores indicate improved oral hygiene status.
The measure evaluates the effectiveness of each instructional method in reducing plaque accumulation in adolescents with fixed orthodontic appliances.
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Baseline and 4 weeks after intervention
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Estomatognáticas
- Enfermedades de los dientes
- Desmineralización de dientes
- Comportamiento
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Cumplimiento del paciente
- Aceptación del paciente de la atención médica
- Intervenciones de adherencia
- Adherencia a la medicación
- Caries dental
- Educación para la salud
Otros números de identificación del estudio
Otros números de identificación del estudio
- IR.TUMS.DENTISTRY.REC.1402.096
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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