- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07730658
Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children
Comparison of Erythritol Air-Polishing and Conventional Polishing Following Ultrasonic Scaling on the Relapse of Chromogenic Tooth Staining in Children: A Randomized Clinical Trial
The goal of this randomized clinical trial is to compare the effect of erythritol air-polishing and conventional polishing following ultrasonic scaling on the relapse of chromogenic tooth staining in children aged 4-13 years attending the Pediatric Dentistry Clinic of Marmara University Faculty of Dentistry for routine dental examination.
The main questions this study aims to answer are:
- Does erythritol air-polishing reduce the relapse of chromogenic tooth staining compared with conventional polishing following ultrasonic scaling?
- Is there a difference in the time to relapse of chromogenic tooth staining between the two polishing techniques?
Researchers will compare conventional polishing (prophylaxis paste and a polishing brush) following ultrasonic scaling with erythritol air-polishing performed using the EMS air-polishing device following ultrasonic scaling to determine whether one method is more effective in preventing or delaying the relapse of chromogenic tooth staining.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Participants will:
Undergo a routine oral examination. Receive professional removal of chromogenic tooth staining using ultrasonic scaling.
Be randomly assigned to receive either conventional polishing with prophylaxis paste and a polishing brush or erythritol air-polishing using the EMS air-polishing device.
Attend follow-up visits to assess the recurrence of chromogenic tooth staining over time.
Chromogenic tooth staining will be assessed using the Qraycam.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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MALTEPE
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Istanbul, MALTEPE, Turquía (Türkiye), 34854
- Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi
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Contacto:
- Betul Sen Yavuz
- Número de teléfono: +90 539 988 76 46
- Correo electrónico: dtbetulsen@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Children aged 4-13 years.
- Absence of oral diseases, including gingivitis and oral mucosal diseases.
- No orthodontic appliances.
- No history of iron supplementation or professional fluoride treatment within the previous 3 months.
- Systemically healthy children.
Exclusion Criteria:
- Presence of oral diseases, including periodontitis, salivary gland diseases, or oral mucosal diseases.
- History of autoimmune disease.
- Antibiotic use within the previous 3 months.
- Consumption of tannin-containing beverages (e.g., tea, coffee, or similar beverages) within the previous 1 month.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Group 1 (Erythritol Air-Polishing Using the EMS Air-Polishing Device)
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Description: Participants assigned to Group 1 will receive professional removal of chromogenic tooth staining using ultrasonic scaling followed by erythritol air-polishing with the EMS air-polishing device, guided by a plaque-disclosing agent.
At the end of the procedure, the investigator will record the treatment time, apply the plaque-disclosing agent, obtain intraoral photographs, and assess chromogenic tooth staining using the Qraycam.
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Comparador activo: Group 2 (Conventional Polishing Using Prophylaxis Paste and a Polishing Brush)
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Participants will undergo professional tooth cleaning using the ultrasonic scaler of the EMS device.
The tooth surfaces will then be polished using a polishing brush and prophylaxis paste.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Black Stain Score
Periodo de tiempo: Baseline, immediately after polishing, 1 month, 2 months, 3 months, and 6 months
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Black Stain Classification (Gasparetto et al., 2003) Score Description Clinical Characteristics 0 None No black pigmentation on the tooth surface.
Black Stain Classification (Zerman et al., 2024) Score Description A Pigmented lines or dots present only on the buccal surface. B Pigmented lines or dots present on both the buccal and lingual surfaces. C Pigmented lines or dots associated with dental caries. D Recurrent pigmented lines or dots. |
Baseline, immediately after polishing, 1 month, 2 months, 3 months, and 6 months
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Participant Feedback
Periodo de tiempo: Periprocedural
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Pain perception during the procedure will be assessed using the Wong-Baker FACES Pain Rating Scale.
The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "hurts worst."
Higher scores indicate greater pain intensity (worse outcome).
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Periprocedural
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Time Session
Periodo de tiempo: Periprocedural
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The duration of treatment is noted and compared between groups
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Periprocedural
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Colaboradores e Investigadores
Patrocinador
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
- GBTvschromogenic
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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