Intraseptal and Periodontal Ligament Anaesthesia for Tooth Extraction in Patients With Type 2 Diabetes
Efficacy and Safety of Intraseptal and Periodontal Ligament Anaesthesia for Extraction of Upper Lateral Incisors and Lower First Premolars in Patients With Type 2 Diabetes Mellitus
The goal of this clinical trial is to compare two local anesthesia techniques, intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA), in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.
The main questions it aims to answer are:
Which technique provides more effective local anesthesia for tooth extraction? Do ISA and PLA differ in their effects on blood pressure and heart rate during the procedure?
Researchers will compare ISA and PLA to determine which method is more effective and safer in this patient population.
Participants will:
Receive local anesthesia (ISA or PLA) using articaine with epinephrine delivered with a computer-controlled system Undergo extraction of a maxillary lateral incisor or mandibular first premolar Have blood pressure and heart rate measured before, during, and after anesthesia and extraction
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This randomized clinical trial was designed to evaluate and compare the clinical efficacy and safety of intraseptal anesthesia (ISA) and periodontal ligament anesthesia (PLA) in patients with controlled type 2 diabetes mellitus undergoing tooth extraction.
Local anesthetic administration in diabetic patients requires careful consideration due to potential cardiovascular responses and altered tissue sensitivity. Alternative injection techniques such as ISA and PLA may provide effective anesthesia while minimizing systemic effects.
A total of 120 participants were randomly assigned to receive either ISA or PLA. All anesthetic procedures were performed using a computer-controlled local anesthetic delivery system (CCLADS) with 0.6 mL of 4% articaine with 1:100,000 epinephrine (Septanest).
The study included extraction of maxillary lateral incisors and mandibular first premolars. Outcomes included anesthetic success rate, onset time, duration and extent of anesthesia, as well as changes in systolic and diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after the procedure.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Vojvodina
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Pančevo, Vojvodina, Serbia
- Faculty of Dentistry in Pančevo, University of Business Academy in Novi Sad
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Controlled Type 2 diabetes mellitus
- Age 35-77 years
- Patients requiring extraction of maxillary lateral incisors or mandibular first premolars
- Teeth free of acute periodontal disease
- No acute dentoalveolar abscess
- No dental treatment within last 48 hours
- No smoking
- No alcohol or drug dependence
- No contraindications to local anesthetic or vasoconstrictor
Exclusion Criteria:
- Smokers
- Patients with alcohol or drug dependence
- Contraindications to local anesthetics or vasoconstrictors
- Acute periodontal disease at the site of injection
- Acute dentoalveolar abscess
- History of tooth trauma or hypersensitivity in target teeth
- Dental treatment within the last 48 hours prior to procedure
- Non-controlled diabetes mellitus (implied, since study includes controlled DM only
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: ISA (Intraseptal Anaesthesia)
Participants received intraseptal anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
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0.6 mL of 4% articaine with 1:100,000 epinephrine administered for intraseptal anaesthesia (ISA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
|
|
Experimental: PLA (Periodontal Ligament Anaesthesia)
Participants received periodontal ligament anaesthesia using 0.6 mL of 4% articaine with 1:100,000 epinephrine administered via a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
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0.6 mL of 4% articaine with 1:100,000 epinephrine administered for periodontal ligament anaesthesia (PLA) using a computer-controlled local anesthetic delivery system (CCLADS) during extraction of maxillary lateral incisors or mandibular first premolars.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anesthetic success rate
Periodo de tiempo: During tooth extraction procedure (5 minutes after administration of local anaesthesia).
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Anesthetic success rate of intraseptal anaesthesia (ISA) compared with periodontal ligament anaesthesia (PLA) during extraction of maxillary lateral incisors and mandibular first premolars in patients with controlled Type 2 diabetes mellitus.
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During tooth extraction procedure (5 minutes after administration of local anaesthesia).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Onset time of local anesthesia
Periodo de tiempo: Immediately after administration of local anesthesia (during procedure)
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Time from completion of anesthetic injection to the establishment of profound anesthesia in adjacent gingival tissue.
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Immediately after administration of local anesthesia (during procedure)
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|
Duration of soft tissue anesthesia
Periodo de tiempo: During and after procedure (measured at 5-minute intervals until sensation returns)
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Time period from onset of anesthesia until return of sensation confirmed by pinprick testing in buccal attached gingiva.
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During and after procedure (measured at 5-minute intervals until sensation returns)
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Width of anesthetic field
Periodo de tiempo: 10 minutes after successful anesthesia
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Extent (in millimeters) of anesthetized area in buccal/lingual/palatal attached gingiva and oral mucosa measured using pinprick testing and a flexible ruler.
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10 minutes after successful anesthesia
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Systolic blood pressure changes
Periodo de tiempo: Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
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Changes in systolic blood pressure before, during, and after administration of local anesthesia.
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Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
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Diastolic blood pressure changes
Periodo de tiempo: Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
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Changes in diastolic blood pressure during perioperative period of anesthesia administration.
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Baseline, during injection, and 5, 10, 15, and 30 minutes post-injection
|
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Mean arterial pressure changes
Periodo de tiempo: Baseline to 30 minutes post-injection
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Changes in mean arterial pressure during and after administration of local anesthesia.
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Baseline to 30 minutes post-injection
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Heart rate changes
Periodo de tiempo: Baseline, during injection, and 5, 10, 15, 30 minutes after administration
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Changes in heart rate during and after administration of local anesthesia using ECG monitoring.
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Baseline, during injection, and 5, 10, 15, 30 minutes after administration
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Vladimir Biocanin, Faculty of Dentistry in Pancevo, Department of Oral Surgery, University of Business Academy in Novi Sad, Serbia
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- No.36/3
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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