Evaluation of Pulpotomy Techniques (Formocresol, Ferric Sulphate, Mineral Trioxide Aggregate) (MTA)
Evaluation of Pulpotomy Techniques (Formocresol ,Ferric Sulphate, Mineral Trioxide Aggregate)
The goal of this interventional study is to evaluate the different materials used for pulpotomy procedures in deciduous molars. this will help us find out which medicament is more effective in releving which medicament is more effective in releving pain and resolution of signs of infection.it will help us find out less chair time for procedure and cooperation of child .
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This interventional study will randomly allocate patients in three groups ( Formocresol, Ferric Sulphate , Mineral trioxide aggregate) based on the inclusion criteria procedure will be started by local local anesthesia with 2% lignocaine. Once anesthesia is achieved caries removal and access opening will be done with a round carbide bur number 6 or 8 and 330 respectively. Coronal pulp tissue will be removed by sharp spoon excavator. Hemostasis will be achieved with a sterile cotton pellet soaked with saline.Teeth in which hemostasis could not be achieved with in 5 minutes will be excluded from the study.these initial steps will be same for all three groups wile subsequent steps will varry according to the treatment group.
For formocresol group a sterile cotton pellet soaked with formocrsol will be placed on radicular pulp stumps for 5 minutes and then removed. Later the pulp stumps will be covered by zinoxide eugenol cement and tooth restored with glass ionomer cement.
For ferric suplahte a solution of 15.5% will be applied on sterile cotton and placed on pulp stumps for 15 seconds .later the pulp stumps will be covered by zinc oxide eugenol cement and tooth restored with glass ionomer cement.
For mineral trioxide aggregate pulpotomy pulp stumps will be covered with mineral trioxide aggregate and tooth will be restored with glass ionomer cement.
Patient will then be recalled for follow up at 2 weeks ,1 month and 6 months. Assessment will be done clinically and radiographically to determine treatment sucess and failure.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: HUMA ZAHIR, FCPS
- Número de teléfono: 923360119081
- Correo electrónico: HUMA.ZAHIR@FUI.EDU.PK
Copia de seguridad de contactos de estudio
- Nombre: SANA QASIM, BDS
- Número de teléfono: 03338885560
- Correo electrónico: SANAQASIM@HOTMAIL.COM
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
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Symptomless carious teeth with vital pulp exposure
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No clinical sign/symptoms of spontaneous and nocturnal pain, and tenderness to percussion or palpation, history of swelling or sinus tracts, pathologic mobility.
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Teeth restorable.
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No radiographic evidence of pulp degeneration such as internal or external resorption, inter-radicular or periapical bone destruction.
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No clinical evidence of pulp degeneration such as excessive bleeding from root canals.
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Teeth having no more than one third of their roots undergoing physiologic resorption.
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Exclusion Criteria:
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Teeth diagnosed with irreversible pulpitis
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Teeth having Pulp necrosis / periapical abscess
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Teeth with previous pulp therapy(pulpotomy/pulpectomy)
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Children with systemic medical conditions that may affect healing or contraindicate treatment.
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Children with special healthcare needs
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Children with known allergy to any of the materials used in the study.
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Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: PULPOTOMY MATERIAL
3 GROUPS GROUP 1:FORMOCRESOL,GROUP 2:FERRIC SULPHATE,GROUP 3 :MINERAL TRIOXIDE AGGREGATE |
FORMOCRESOL PULPOTOMY MATERIAL FOR 5MINUTES PACKED WITH STERILE COTTON PELLETS ON PULP STUMPS FERRIC SULPHATE 15.5 % PACKED ON PULP STUMPS WITH STERILE COTTON PELLET FOR 15 SECONDS. MINERAL TRIOXIDE AGGREGATE PLACED ON PULP STUPMS
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PAIN RELIEF
Periodo de tiempo: 2WEEKS ,1 MONTH ,6 MONTHS
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PAIN RELIEF ASSESMENT BY SCALE 0-10 (O no pain ,1-3 mild pain, 4-7 moderate pain ,8-10 extreme pain) |
2WEEKS ,1 MONTH ,6 MONTHS
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Igna A. Vital pulp therapy in primary dentition: Pulpotomy-a 100-year challenge. Children. 2021;8(10). 2. A randomized controlled trial comparing - PubMed Mobile [Internet]. Available from: http://www.ncbi.nlm.nih.gov/m/pubmed/20801246/?i=4&from=leaver+maher 3. Roy S, Garg N, Pathivada L, Choudhary R, Kaur H, Yeluri R. Comparative Evaluation of Low-level Diode Laser and Electrosurgical Pulpotomy in Primary Molars. Int J Clin Pediatr Dent. 2023;16(4):612-8. 4. Tewari N, Goel S, Mathur VP, O'Connell AC, Johnson RM, Rahul M, et al. Success of medicaments and techniques for pulpotomy of primary teeth: An overview of systematic reviews. Int J Paediatr Dent. 2022;32(6):828-42. 5. Eshghi A, Hajiahmadi M, Nikbakht MH, Esmaeili M. Comparison of Clinical and Radiographic Success between MTA and Biodentine in Pulpotomy of Primary Mandibular Second Molars with Irreversible Pulpitis: A Randomized Double-Blind Clinical Trial. Int J Dent. 2022;2022. 6. Philip N, Cherian JM, Mathew MG, Thomas AM, Jodhka S, John N, et al. Treatment outcomes of pulpotomy versus pulpectomy in vital primary molars diagnosed with symptomatic irreversible pulpitis: protocol for a non-inferiority randomised controlled trial. BMC Oral Health [Internet]. 2024;24(1):1-10. Available from: https://doi.org/10.1186/s12903-024-04411-6 7. Yildiz E, Tosun G. Evaluation of formocresol , calcium hydroxide , ferric sulfate , and MTA primary molar pulpotomies. 2019;8(2). 8. Guo J, Zhang N, Cheng Y. Comparative efficacy of medicaments or techniques for pulpotomy of primary molars: a network meta-analysis. Clin Oral Investig. 2023;27(1):91-104. 9. Simonoska J, Bjelica R, Dimkov A, Simjanovska J, Gabrić D, Gjorgievska E. Efficacy of Laser Pulpotomy vs. Conventional Vital Pulpotomy in Primary Teeth: A Comparative Clinical Analysis. Children. 2025;12(3):1-11. 10. Pulpotomy E. Original Article. 2018;
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
- FUCD-PEADS- 2601
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
PATIENT CONFIDENTIALITY NEEDS TO BE MAINTAINED.
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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