- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05185206
Comparative Evaluation of the Post Operative Sensitivity of Cention-N(Commercially Available Restorative Material) Using Conventional and Polymer Bur- In-vivo Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Dental caries is a multifactorial disease which is very much prevalent in India occurring especially in high economic group and some in middle and lower economic groups of world population.The most common instruments used for excavation of dental caries are the use of diamond and carbide burs.There is effective removal of the carious tooth structure through these burs which leads to excess removal of tooth structure and weakening the teeth.
Timely advancement in dentistry and the quest for the development of ideal esthetic materials to replace lost dental tissue has led to use of Cention-N(commercially available restorative material) to restore posterior teeth. Cention N(commerically available restorative material) is a recently introduced tooth-coloured, basic filling material for bulk placement in retentive preparations with or without the application of an adhesive. It is an alkise restorative which is a new category of filling material, like compomer(commercially available restorative material) or ormocer(commercially available restorative material) and is essentially a subgroup of the composite resin. Cention-N(commercially available restorative material)offers a cost-effective substitute for amalgam and also fulfills the need of an esthetic bulk fill material in the posterior region. Patients have described post-operative sensitivity as a moderate pain, of short duration, that appears spontaneously when chewing, with hot and cold foods and on rare occasions with sweet and acid foods, and it disappears when the stimulus is removed. It is characterized by an acute pain that can last for days or weeks and disappears when the stimulus is removed.It results from the interaction between the restorative technique, the clinical condition of the tooth to be treated (health of the pulp and remaining hard dental tissue) and the restorative material. Therefore, there is a permanent and unpredictable possibility of sensitivity occurring. In addition, there are other factors related to the cause of post- operative sensitivity, such as the individual profile of each patient, the shape and extension of the cavity preparation and protection of the dentin-pulp complex. Hence the novelty of this study is to evaluate of the post operative sensitivity of Cention-n (commerically available restorative material)using conventional and polymer bur.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Soumya S Shetty, MDS
- Número de teléfono: 8888200888
- Correo electrónico: drsoumyasshetty@gmail.com
Ubicaciones de estudio
-
-
Maharashtra
-
Pune, Maharashtra, India, 411018
- Reclutamiento
- Dr D.Y. Patil Dental College and Hospital, Pimpri
-
Contacto:
- Soumya S Shetty, MDS
- Número de teléfono: 888820088
- Correo electrónico: drsoumyasshetty@gmail.com
-
Contacto:
- Riya A Parwani, BDS
- Número de teléfono: 9922929705
- Correo electrónico: riyaparwani2307@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients aged between 18 and 55 years having class 1 occlusal caries(1.2 according to G. J. Mount classification) on both sides of arch. In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph.
- Roots with closed apex.
- Systematically healthy patients.
- Patients with no other symptomatic tooth involved
Exclusion Criteria:
- Teeth with the presence of any pathologic pulpal disease with or without pain.
- Teeth with previous restorations, any defective restoration adjacent to or opposing the affected tooth.
- Teeth with surface loss due to attrition, erosion, abrasion, or abfraction.
- Patients with poor oral hygiene, severe, or chronic periodontitis.
- Patient on medication which may hinder the response to sensitivity.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Analysis of post-operative sensitivity after caries removal using conventional steel bur
Caries will be excavated using a carbide on one side of the arch and restoration will be done with Cention-N(commercially available restorative material) as per manufacturer's instructions.Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity.
The pain intensity will be recorded with the Visual Analog Scale.
|
Patients aged between 18 and 55 years having class 1 occlusal caries(1.2
according to G. J. Mount classification) on both sides of arch.
In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph.
This will be followed by caries removal with convention steel bur followed by restoration with Cention-n and checking of postoperative sensitivity using Visual Analog Scale.The Visual Analog Scale consists of a 100-mm line divided into equal intervals of 10 mm, where 0 represents "absence of pain" and 100 "severe pain."
The results of Visual Analog Scale will be classified as mild (0-30 mm), moderate (40-70 mm), or severe pain (> 70 mm).
|
|
Experimental: Analysis of post-operative sensitivity after caries removal using polymer bur
Caries will be excavated using a polymer on one side of the arch and restoration will be done with Cention-N(commercially available restorative material) as per manufacturer's instructions.Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity.
The pain intensity will be recorded with the Visual Analog Scale.
|
Patients aged between 18 and 55 years having class 1 occlusal caries(1.2
according to G. J. Mount classification) on both sides of arch.
In order to standardise the cavity preparation depth(approximately 1.5 to 2mm from the roof of the pulp chamber), the distance from occlusal surface to roof of pulp chamber will be used for measuring with the radiograph.
This will be followed by caries removal with polymer bur followed by restoration with Cention-n and checking of postoperative sensitivity using Visual Analog scale.The Visual Analog Scale consists of a 100-mm line divided into equal intervals of 10 mm, where 0 represents "absence of pain" and 100 "severe pain."
The results of Visual Analog Scale will be classified as mild (0-30 mm), moderate (40-70 mm), or severe pain (> 70 mm).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Periodo de tiempo: Post operative sensitivity will be checked after 24 hours.
|
Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity.
The pain intensity will be recorded with the visual analog scale (VAS).
|
Post operative sensitivity will be checked after 24 hours.
|
|
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Periodo de tiempo: Post operative sensitivity will be checked after 15 days.
|
Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity.
The pain intensity will be recorded with the visual analog scale (VAS).
|
Post operative sensitivity will be checked after 15 days.
|
|
Post-operative sensitivity checked using Visual Analog Scale by thermal stimulus.
Periodo de tiempo: Post operative sensitivity will be checked after 30 days.
|
Thermal stimulation (refrigerant spray Endo-Ice) will be used to evaluate the type of sensitivity.
The pain intensity will be recorded with the Visual Analog Scale.
|
Post operative sensitivity will be checked after 30 days.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- DYPDCH/IEC/123/99/19
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. .