Clinical Application of Er:YAG Dental Laser System
22 de marzo de 2021 actualizado por: Kaohsiung Medical University Chung-Ho Memorial Hospital
The study aim was to evaluate the effectiveness of Er:YAG dental laser treatment modality for cavity, sensitive teeth, abnormal frenum attachment and peri-implantitis.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
There are four indications will be included in this plan. They are Cavity, Sensitive Teeth, Abnormal Frenum Attachment and Peri-implantitis. Each indication has different procedures which are listed as below:
Cavity: history records, affected range check, X-ray&photo, treatment, pain index check, return visit check after two weeks. Sensitive Teeth: history records, sensitive check, X-ray&photo, treatment, pain index and effectiveness check, return visit check after two weeks. Abnormal Frenum Attachment: history records, abnormal position check, photo, cutting, pain index check, return visit check after three, five and seven days. Peri-implantitis: History records, measure periodontal pocket depth, anaerobes collect, X-ray, photo, CT, treatment, pain index check, return visit check after one week, two weeks, four weeks and three months, six months check the effectiveness and collect anaerobes during every return visit. In the last return visit, X-ray and CT would be included.
Tipo de estudio
Intervencionista
Inscripción (Actual)
129
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Kaohsiung, Taiwán, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
20 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Ages: 20 years and above。
- Patients are available for multiple follow-up visits for the duration of the study.
- Having the mental ability to express informed consent.
- Patients clinically diagnosed as having Cavity, Sensitive Teeth, Abnormal Frenum Attachment or Peri-implantitis.
Exclusion Criteria:
- Severe diabetes and chronic diseases are excluded.
- CVA patients or the patients taking anti-rejection medicine and osteoporosis drugs for long-term should be excluded.
- Patient who suffer from photodermatosis and photosensitive patients (photoallergic).
- The health condition is not well after health education and physical therapy are excluded.
- Surgery on patients with serious diseases of the hemopoietic system (such as haemophilia and leukaemia).
- Malignant tumours, obligate precancerous tumours, hemangiomas.
- Coronary heart disease and chronic obstructive pulmonary diseases are excluded.
- Pregnant woman.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Cavity group
The 35 participants accepted Er:YAG laser treatment for dental cavity.
Each participant was collected their data including history records, affected range check, X-ray&photo, treatment, pain index check, return visit check after two weeks by researchers.
|
To treat Cavity, Sensitive Teeth, Abnormal Frenum Attachment and Peri-implantitis by using Er:YAG Dental Laser system which manufactured by LightMed Dental Technology Corp
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Experimental: Sensitive Teeth group
The 35 participants accepted Er:YAG laser treatment for sensitive teeth.
Each participant was collected their data including history records, sensitive check, X-ray&photo, treatment, pain index and effectiveness check, return visit check after two weeks by researchers.
|
To treat Cavity, Sensitive Teeth, Abnormal Frenum Attachment and Peri-implantitis by using Er:YAG Dental Laser system which manufactured by LightMed Dental Technology Corp
|
|
Experimental: Abnormal Frenum Attachment group
The 35 participants accepted Er:YAG laser treatment for Abnormal Frenum Attachment.
Each participant was collected their data including history records, abnormal position check, photo, cutting, pain index check, return visit check after three, five and seven days.
by researchers.
|
To treat Cavity, Sensitive Teeth, Abnormal Frenum Attachment and Peri-implantitis by using Er:YAG Dental Laser system which manufactured by LightMed Dental Technology Corp
|
|
Experimental: Peri-implantitis intervention group
The 12 participants accepted Er:YAG laser treatment for Peri-implantitis.
Each participant was collected their data including History records, measure periodontal pocket depth, anaerobes collect, X-ray, photo, CT, treatment, pain index check, return visit check after one week, two weeks, four weeks and three months, and six month check the effectiveness and collect anaerobes during every return visit.
In the last return visit, X-ray and CT would be included
|
To treat Cavity, Sensitive Teeth, Abnormal Frenum Attachment and Peri-implantitis by using Er:YAG Dental Laser system which manufactured by LightMed Dental Technology Corp
|
|
Sin intervención: Peri-implantitis control group
The 12 participants accepted mechanical debridement for Peri-implantitis.
Each participant was collected their data including History records, measure periodontal pocket depth, anaerobes collect, X-ray, photo, CT, treatment, pain index check, return visit check after one week, two weeks, four weeks and three months, and six month check the effectiveness and collect anaerobes during every return visit.
In the last return visit, X-ray and CT would be included
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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pain index
Periodo de tiempo: two weeks
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The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain.
It is based solely on the ability to perform activities of daily living (ADLs) and can be used for adults and children 10 years old or older
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two weeks
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sensitive check
Periodo de tiempo: two weeks
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The dentist asked participants few questions about dental status.
Do you feel sudden discomfort in your teeth when you drink hot or cold beverages you once considered normal?
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two weeks
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Abnormal Frenum Attachment
Periodo de tiempo: a week
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wound healing status
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a week
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Probing depth
Periodo de tiempo: six months
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dentist measurement participant's probing depth the distance from the gingival margin to pocket base
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six months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
8 de diciembre de 2017
Finalización primaria (Actual)
29 de octubre de 2019
Finalización del estudio (Actual)
29 de octubre de 2019
Fechas de registro del estudio
Enviado por primera vez
22 de marzo de 2021
Primero enviado que cumplió con los criterios de control de calidad
22 de marzo de 2021
Publicado por primera vez (Actual)
23 de marzo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de marzo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
22 de marzo de 2021
Última verificación
1 de marzo de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- KMUHIRB-F(II)-20170083
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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