Outcome of Selective Caries Removal Performed by Undergraduate Students
Selective Caries Removal in Deep Carious Lesions of Permanent Teeth by Undergraduate Dental Students: A Prospective Clinical Study
Deep tooth decay can sometimes reach very close to the nerve of a tooth. Traditionally, dentists may remove all of the decayed tooth tissue, but removing too much tissue can increase the risk of exposing or damaging the nerve.
This study is looking at a more conservative way of treating deep tooth decay called selective removal of tooth decay. Instead of removing all the affected tissue close to the nerve, some of it is carefully left in place to help protect the nerve and preserve the tooth.
We will compare two ways of doing this. In one group, the dentist will remove the decay until softer tooth tissue remains near the nerve. In the other group, the dentist will remove more of the decay until firmer, leathery tooth tissue remains.
About 100 patients with deep tooth decay in permanent teeth will take part in the study. The treatment will be provided by trained fifth-year dental students under supervision and using standardized procedures.
After treatment, patients will be asked about any pain at 1, 3, and 7 days. The treated teeth will also be checked clinically and with dental X-rays at 6 and 12 months.
The purpose of the study is to find out whether either approach provides better outcomes while preserving the health of the tooth. The results may help dentists choose the most appropriate and conservative way to treat deep tooth decay and may also help improve dental student training.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
This is a prospective, randomized clinical study evaluating two approaches to selective caries removal (SCR) for the management of deep carious lesions in permanent teeth. The study will compare selective caries removal to soft dentine with selective caries removal to firm/leathery dentine. The aim is to determine whether the texture of the dentine left over the pulp influences clinical and radiographic treatment outcomes.
Following approval by the Institutional Review Board, eligible patients will be recruited from the dental teaching clinics at Jordan University of Science and Technology (JUST). Written informed consent will be obtained from all participants before enrollment. Approximately 100 patients will be included, with one tooth per patient. Participants will be randomly allocated in a 1:1 ratio to receive selective caries removal to either soft dentine or firm/leathery dentine.
Selective caries removal will be performed under rubber dam isolation according to a standardized clinical protocol. Soft dentine will be defined as soft, wet, easily deformable dentine that can be readily removed with a hand instrument. Firm/leathery dentine will be defined as drier, rubbery, less compressible dentine that provides moderate resistance to excavation. Following caries removal, the cavity will be disinfected and restored using a standardized adhesive restorative procedure.
Treatment will be performed by fifth-year undergraduate dental students under the supervision of experienced dental specialists. Supervisors will be calibrated before the study using standardized clinical cases, including clinical photographs, radiographs, and videos. Cases will be distributed among supervisors to promote consistent clinical supervision and standardization of treatment.
Baseline information, including patient and tooth characteristics, pain history, and caries risk, will be recorded. Postoperative pain will be assessed at 1, 3, and 7 days after treatment. Clinical and radiographic examinations will be performed at 6 and 12 months to evaluate the condition and treatment outcome of the treated teeth.
The study will assess whether selective caries removal to soft dentine provides outcomes comparable to or different from selective caries removal to firm/leathery dentine. The findings may help determine the most appropriate extent of caries removal for deep lesions and provide evidence to support conservative caries management in undergraduate dental education.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Irbid, Jordán, 3030
- Jordan University of Science and Technology
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients in good general health (ASA I or II).
- One permanent tooth with a deep carious lesion involving ≥ ¾ of the dentine on bitewing radiograph.
- Positive response to cold and/or electric pulp testing.
- Bite-wing radiographic evidence of a well-defined radiodense zone between the carious lesion and the pulp.
Exclusion Criteria:
- Irreversible pulpitis
- Need for post and core restoration
- Non restorable teeth
- Negative response to sensibility testing
- Inability to isolate the tooth via rubber dam
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Selective craies removal to soft dentine
Dental caries will be cleaned from peripheries and soft dentine will be left over the pulpal wall
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Selective removal of carious dentine until soft dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration.
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Comparador activo: Selective caries removal to firm dentine
Dental caries will be cleaned from peripheries and firm dentine will be left over the pulpal wall
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Selective removal of carious dentine until firm/leathery dentine remains over the pulp, followed by standardized cavity disinfection and adhesive restoration.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Success
Periodo de tiempo: 6, 12, 24, 36 months
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Treatment success will be assessed based on the clinical and radiographic condition of the treated tooth.
Clinical success will include absence of spontaneous pain, tenderness to percussion, swelling, sinus tract, or other signs of pulpal or periapical disease.
Radiographic success will be defined by tooth vitality and response to sensibility testing and absence of periapical pathology on follow-up radiographs.
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6, 12, 24, 36 months
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postopertive pain
Periodo de tiempo: 1, 3, 7 days postoperative
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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.
Participants will report their pain intensity following treatment, and any analgesic use during the postoperative period will also be recorded.
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1, 3, 7 days postoperative
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Tooth survival
Periodo de tiempo: 12, 24, 36 months
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Tooth survival will be assessed by determining whether the treated tooth remains present and functional during the follow-up period.
Tooth survival will be defined as retention of the treated tooth without extraction.
The need for additional endodontic treatment or other major intervention will also be recorded.
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12, 24, 36 months
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
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 (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 494/2025
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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