- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07625839
A Comparative Clinical Assessment of Adjunctive Hyaluronic Acid With 3D Printed Versus Milled CAD CAM Provisional Dental Restorations on Active Periodontal Status and Surface Roughness and Biocompatibility
A Comparative Clinical Assessment of Adjunctive Hyaluronic Acid With 3D Printed Versus Milled CAD CAM Provisional Dental Restorations on Active Periodontal Status and Surface Roughness and Biocompatibility (A Randomized Controlled Clinical Trial)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This randomized clinical trial evaluates their effects regarding periodontal assessment, including
- Clinical attachment loss (CAL)
- Plaque Index (PI)
- Gingival Index (GI)
- Bleeding on probing (BOP)
- using digital scanner then a profilometer to measure surface roughness
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Systemic healthy patients
- Patients aged > 25 years
- Patients suffering from stage II periodontitis with grade B were included in this study, according to 2017 world workshop classification of periodontal disease (Papapanou et al. 2017).
- Patients with interdental clinical attachment loss (CAL) of 3-4 mm
- No history of previous periodontal therapy.
- No taken medications known to interfere healing or periodontal tissue health such as anticonvulsants, calcium channel blockers, or immunosuppressant drugs.
- No previous periodontal surgery at involved sites.
- Good oral hygiene and good compliance with the plaque control instructions following initial therapy.
- Neither taken antibiotics within the last three months nor nonsteroidal anti-inflammatory drugs within the last three months
- Absence of diseases or conditions that would interfere with wound healing such as diabetes mellitus or coagulation disorders
- Absence of oral mucosal inflammatory conditions such as aphthous ulcers or lichen planus.
Exclusion Criteria:
Smoking habits
- Pregnant and lactating mothers
- Patients who have been received periodontal surgery in the study area during the last 6 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention Study Group
Group (A and B): 3D Printed Dental Restoration with hyaluronic acid and Milled CAD CAM Dental Restoration with hyaluronic acid.
|
While control both procedures will be done but without using hyaluronic acid |
|
Comparador activo: Control Group
Group (C and D): 3D Printed Dental Restoration without hyaluronic acid and Milled CAD CAM Dental Restoration without hyaluronic acid
|
While control both procedures will be done but without using hyaluronic acid |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinical Attachment Loss (CAL)
Periodo de tiempo: Day 0 - month 3
|
• will be measured clinically using UNC periodontal probe from cemento enamel junction to depth of periodontal pocket
|
Day 0 - month 3
|
|
bleeding on probing (BOP)
Periodo de tiempo: Day 0 - month 3
|
will be measured clinically using UNC periodontal probe. Count the bleeding points and divided them by the total number of patients' teeth in the oral cavity and multiply by 100 to make the percent. localized less than 30% and generalized greater than or equal 30% |
Day 0 - month 3
|
|
Plaque index (PI)
Periodo de tiempo: Day 0 - month 3
|
plaque index This clinical method assesses the thickness of plaque specifically at the cervical margin (gumline). The Scoring Scale (0 to 3): 0: No plaque in the gingival area.
|
Day 0 - month 3
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
biocompatibility
Periodo de tiempo: Day 0 - month 3
|
• will be calculated through measuring Bop, gingival index, and plaque index as mentioned before.
|
Day 0 - month 3
|
|
Surface roughness
Periodo de tiempo: Day 0 - month 3
|
will be measured using a surface roughness measuring instrument (or profilometer) is a precision device used to evaluate the texture of a material by measuring microscopic peaks and valleys.
They are essential for quality control in manufacturing to ensure components meet strict friction, wear, and coating adhesion standards.
|
Day 0 - month 3
|
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
Otros números de identificación del estudio
- 15022026
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .