Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Comparative Evaluation of NeoPUTTY and MTA Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis

13 de julio de 2026 actualizado por: Postgraduate Institute of Dental Sciences Rohtak

Comparative Evaluation of Success of NeoPUTTY Pulpotomy and MTA Pulpotomy in Mature Permanent Molars With Irreversible Pulpitis: A Randomized Clinical Study

When a permanent back tooth develops severe nerve inflammation that cannot heal on its own, a procedure called pulpotomy can be performed to remove the diseased nerve tissue from the crown of the tooth while preserving the healthy roots. This helps save the tooth and avoid extraction. Two materials are commonly used to cover the remaining nerve tissue after pulpotomy: Mineral Trioxide Aggregate (MTA), which is considered the gold standard, and NeoPUTTY, a newer premixed calcium silicate material that is easier to use and requires no mixing.

This study was conducted to compare the success of NeoPUTTY and MTA when used for full pulpotomy in mature permanent back teeth of children aged 9 to 14 years who had severe toothache due to irreversible nerve inflammation. Forty-six children were enrolled and randomly assigned to receive either NeoPUTTY or MTA after complete removal of the nerve tissue from the crown of the tooth. All teeth were restored with a definitive filling in the same visit. Children were followed up at 1, 3, 6, and 12 months to assess clinical success, and radiographic assessment was performed at 6 and 12 months. Pain after the procedure was recorded at 24 hours and the time taken to stop bleeding during the procedure was also recorded.

The study aimed to determine whether NeoPUTTY offers comparable results to MTA as a pulpotomy material in permanent teeth of children, which could help guide clinical decision-making in pediatric dental practice.

Descripción general del estudio

Descripción detallada

Irreversible pulpitis in mature permanent teeth presents a clinical challenge in pediatric dentistry, as conventional treatment options include either root canal therapy or extraction. Full pulpotomy, involving complete removal of the coronal pulp while preserving vital radicular pulp tissue, has emerged as a biologically conservative alternative supported by growing evidence. The success of pulpotomy depends critically on the pulp capping material used, which must provide an adequate seal, promote dentinal bridge formation, and maintain radicular pulp vitality.

Mineral Trioxide Aggregate (MTA) has been extensively studied and is considered the gold standard pulpotomy material due to its biocompatibility, sealing ability, and capacity to induce hard tissue formation. However, its clinical use is limited by the need for manual mixing, long setting time, handling difficulties, and high cost. NeoPUTTY (NuSmile Ltd., Houston, TX, USA) is a premixed, ready-to-use calcium silicate bioceramic material based on the same tricalcium and dicalcium silicate chemistry as MTA. It requires no mixing, is immediately wash-out resistant, and offers improved handling characteristics. Previous studies have evaluated NeoPUTTY in primary teeth, but evidence in mature permanent teeth was limited at the time this study was initiated.

This randomized parallel-group clinical trial was conducted at the Department of Pedodontics and Preventive Dentistry, Post Graduate Institute of Dental Sciences (PGIDS), Rohtak, India, a government dental institution under Pt. B.D. Sharma University of Health Sciences, Haryana. The study was approved by the Biomedical and Health Research Ethics Committee, PGIDS, Rohtak (Approval No. PGIDS/BHRC/24/48, dated 14/05/2024) and conducted in accordance with the Declaration of Helsinki and ICMR guidelines. Written informed consent was obtained from parents or legal guardians of all participating children prior to enrollment.

Participants were randomly allocated in a 1:1 ratio using the lottery method, with allocation concealment achieved through sequentially numbered opaque sealed envelopes. All procedures were performed by a single trained operator under rubber dam isolation. After caries removal and access cavity preparation, complete coronal pulp amputation was performed using a high-speed diamond bur under copious irrigation. Haemostasis was achieved using sterile cotton pellets moistened with 5 percent sodium hypochlorite solution applied for up to 5 minutes. Cases failing to achieve haemostasis within 25 minutes were excluded. The pulpotomy material (NeoPUTTY or MTA Angelus, Londrina, Brazil) was then applied as a 2 to 3 mm thick layer over the pulp stumps, followed by a glass ionomer cement base and definitive composite resin restoration placed in the same visit. Outcome assessors were blinded to group allocation and radiographs were anonymised prior to evaluation.

Tipo de estudio

Intervencionista

Inscripción (Actual)

46

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

    • Haryana
      • Rohtak, Haryana, India, 124001
        • Post Graduate Institute of Dental Sciences, Rohtak

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

  • Niño

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Systemically healthy children aged 9 to 14 years with mature permanent maxillary or mandibular molars presenting with symptomatic irreversible pulpitis, characterized by spontaneous pain, lingering thermal pain, or referred pain of moderate or severe intensity per Wolters classification
  • Teeth with complete root development and closed apices confirmed radiographically, with adequate remaining coronal tooth structure for definitive restoration
  • Deep or extremely deep carious lesions with risk of or unavoidable pulp exposure during operative treatment
  • Teeth with normal periapical radiographic appearance or mild periapical changes limited to slight widening of periodontal ligament space or subtle trabecular alterations without frank periapical radiolucency or loss of lamina dura continuity
  • Teeth free from advanced periodontal disease
  • Parents or legal guardians willing to provide written informed consent and comply with follow-up schedule

Exclusion Criteria:

  • Children with systemic diseases or known hypersensitivity to any material used in the study
  • Teeth with immature root development or incomplete apical closure
  • Non-restorable teeth with inadequate remaining coronal tooth structure
  • Teeth with pathological mobility, sinus tract, or soft tissue swelling
  • Established apical periodontitis with frank periapical radiolucency, furcation involvement, or loss of lamina dura continuity on radiographic examination
  • Evidence of internal or external pathological root resorption
  • Failure to achieve haemostasis within 25 minutes of coronal pulp amputation
  • Lack of parental or guardian consent or unwillingness to comply with follow-up visits

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Group 1: NeoPUTTY
Full pulpotomy using NeoPUTTY (NuSmile Ltd., Houston, TX, USA), a premixed calcium silicate bioceramic material, applied as a 2 to 3 mm layer over radicular pulp stumps following complete coronal pulp amputation, haemostasis with 5 percent sodium hypochlorite, and immediate definitive composite restoration
Premixed calcium silicate bioceramic material (NeoPUTTY, NuSmile Ltd., Houston, TX, USA) applied as a 2 to 3 mm layer over radicular pulp stumps following complete coronal pulp amputation under rubber dam isolation
Comparador activo: Group 2: MTA
Full pulpotomy using white Mineral Trioxide Aggregate (MTA Angelus, Angelus Odonto, Londrina, Brazil), applied as a 2 to 3 mm layer over radicular pulp stumps following complete coronal pulp amputation, haemostasis with 5 percent sodium hypochlorite, and immediate definitive composite restoration
White mineral trioxide aggregate (MTA Angelus, Angelus Odonto, Londrina, Brazil) applied as a 2 to 3 mm layer over radicular pulp stumps following complete coronal pulp amputation under rubber dam isolation

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Clinical and radiographic success of full pulpotomy
Periodo de tiempo: 1 month, 3 months, 6 months, and 12 months (clinical); 6 months and 12 months (radiographic)
Clinical success was defined as absence of spontaneous pain, tenderness to percussion, pathological mobility, sinus tract, and soft tissue swelling. Radiographic success was defined as absence of periapical radiolucency, internal or external pathological root resorption, and furcation radiolucency. Overall success required fulfillment of both clinical and radiographic criteria simultaneously at each evaluation timepoint.
1 month, 3 months, 6 months, and 12 months (clinical); 6 months and 12 months (radiographic)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Postoperative pain
Periodo de tiempo: 24 hours postoperatively
Pain assessed using Visual Analogue Scale (VAS) scored 0 to 10
24 hours postoperatively
Intraoperative haemostasis time
Periodo de tiempo: Intraoperative
Time in minutes taken to achieve haemostasis following coronal pulp amputation using sodium hypochlorite moistened cotton pellets
Intraoperative

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Dr. Shiwani Chawla, Post Graduate Institute of Dental Sciences, Rohtak

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)

19 de mayo de 2024

Finalización primaria (Actual)

20 de noviembre de 2025

Finalización del estudio (Actual)

20 de noviembre de 2025

Fechas de registro del estudio

Enviado por primera vez

8 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

8 de julio de 2026

Publicado por primera vez (Actual)

14 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • PGIDS/BHRC/24/48

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.

Sí

producto fabricado y exportado desde los EE. UU.

Sí

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. .

Suscribir