- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07768852
Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis
Outcome, Quality of Life and Patient Satisfaction After Full Pulpotomy in Permanent Teeth With Irreversible Pulpitis and Apical Periodontitis: A Prospective Exploratory Clinical Study.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a single-arm, prospective clinical study evaluating the effectiveness of full pulpotomy in mature permanent posterior teeth diagnosed with symptomatic or asymptomatic irreversible pulpitis and associated periapical radiolucency. The study will be conducted at the endodontic postgraduate, with a minimum target of 30 teeth in 30 patients recruited consecutively during the study period.
Eligible teeth will undergo clinical and radiographic assessment, including cold sensibility testing, percussion, palpation, periodontal assessment, and periapical radiography. Following local anesthesia and rubber dam isolation, caries will be completely removed and full pulpotomy will be performed to the level of the root canal orifices. The vitality of the remaining pulp tissue will be assessed clinically. Hemostasis will initially be attempted using sodium hypochlorite-moistened cotton pellets. A 980-nm diode laser will then be applied to the pulp tissue to assist hemostasis. Following adequate hemostasis, a calcium silicate-based pulp capping material will be placed over the pulp stumps, followed by a resin-modified glass ionomer liner and definitive resin composite restoration.
Teeth found to have complete pulpal necrosis or in which adequate hemostasis cannot be achieved will not proceed with the pulpotomy protocol and will receive appropriate endodontic treatment according to the clinical findings.
Clinical and radiographic follow-up will be performed at 6 and 12 months, with additional follow-up planned at 24 and 36 months. Periapical radiographs will be obtained during follow-up, and limited-field CBCT will be obtained immediately after treatment and at 12 months to assess changes in the periapical lesion. Treatment success will be determined based on the absence of clinical signs and symptoms and evidence of resolution or reduction of the periapical lesion. Radiographic healing will be assessed by comparing follow-up images with baseline postoperative images.
Patient-reported outcomes will include postoperative pain, analgesic intake, oral health-related quality of life, and patient satisfaction. Pain will be assessed before treatment and at 3 days and 1 week after treatment. Oral health-related quality of life and patient satisfaction will be assessed before treatment, at 1 week, and at 12 months.
The study will provide clinical and radiographic evidence regarding the feasibility and outcome of full pulpotomy in selected permanent teeth with irreversible pulpitis and periapical radiolucency. It will also assess patient-reported outcomes associated with this treatment approach and explore whether full pulpotomy may represent a less invasive alternative to conventional root canal treatment in appropriately selected cases.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nessrin Taha, DclinDent (Endo), PhD
- Número de teléfono: +962776566110
- Correo electrónico: n.taha@just.edu.jo
Copia de seguridad de contactos de estudio
- Nombre: Nessrin Taha, PhD
- Número de teléfono: +962777258907
- Correo electrónico: nessrin_taha@yahoo.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
• Non -contributory medical history (SAI, II).
- Posterior permanent tooth (premolar, molar).
- Age range 8-30 years
- Deep caries extending into the inner quarter of dentin or exposing the pulp on the periapical radiograph
- The tooth should give positive response to cold sensibility testing
- Clinical diagnosis of symptomatic/asymptomatic irreversible pulpitis based on the symptoms, radiographic findings and results of cold testing
- The tooth is restorable, probing pocket depth and mobility are within normal limits
- Periapical radiograph demonstrates the presence of periapical lesion.
Exclusion Criteria:
- Non-restorable tooth.
- Signs of pulpal necrosis including sinus tract or swelling.
- Evidence of necrotic tissue in one or all canals.
- Profuse pulpal bleeding and inability to achieve hemostasis.
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 for permanent teeth with irreversible pulpitis and apical periodontitis.
Participants will receive full pulpotomy for permanent teeth with irreversible pulpitis and apical periodontitis.
Treatment outcomes will be evaluated clinically and radiographically during follow-up.
|
Full pulpotomy will be performed in permanent teeth with irreversible pulpitis and apical periodontitis, with diode laser-assisted hemostasis and calcium silicate-based pulp capping.
The intervention is distinguished by the treatment of teeth with radiographic evidence of apical periodontitis using a full pulpotomy approach rather than conventional root canal treatment.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Success of pulpotomy
Periodo de tiempo: 6 and 12 months
|
Treatment success will be determined by the absence of clinical signs and symptoms of disease, together with radiographic evidence of healing or reduction of the periapical lesion.
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6 and 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative pain
Periodo de tiempo: 3 and 7 days after treatment
|
Postoperative pain will be assessed using a numerical rating scale from 0 to 10, where 0 represents no pain and 10 represents the most severe pain.
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3 and 7 days after treatment
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Oral health-related quality of life
Periodo de tiempo: Before treatment, 1 week and 12 months after treatment
|
Oral health-related quality of life will be assessed using the Oral Health Impact Profile questionnaire modified for endodontic treatment.
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Before treatment, 1 week and 12 months after treatment
|
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Tooth Survival
Periodo de tiempo: 12, 24, and 36 months
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Tooth survival will be assessed based on percentage of the treated teeth remains present and functional during the follow-up period.
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12, 24, and 36 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Nessrin Taha, DClinDent, PhD, Jordan University of Science and Technology
Publicaciones y enlaces útiles
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 550/226
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
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