- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07647861
Efficacy of Lasers, Propolis-Based Agent, and Sham for Dentine Hypersensitivity
Comparison of Nd:YAG Laser, Diode Laser, Herbal Propolis-Based Dentin Barrier Agent, and Sham Application in the Treatment of Dentine Hypersensitivity: A Randomized Controlled Clinical Trial
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This study was conducted as a prospective, randomized, parallel-arm, evaluator-blinded, sham-controlled clinical trial to evaluate and compare the clinical efficacy of four different treatment modalities for dentine hypersensitivity over a 6-month follow-up period.
A total of 140 patients who met the eligibility criteria were enrolled and randomly allocated into four equal groups (n=35 per group) using a block randomization method with a 1:1:1:1 allocation ratio. The intervention groups were assigned as follows:
Group 1 received Nd:YAG laser application.
Group 2 received Diode laser application.
Group 3 received a topical application of a herbal propolis-based dentin barrier agent.
Group 4 received a sham (placebo) application to simulate the treatment experience without delivering any active laser or therapeutic agent benefits.
Clinical evaluations were performed at baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months. The primary outcome was the change in pain intensity measured by the Visual Analog Scale (VAS) following a controlled air blast stimulus from baseline to 6 months. Secondary outcomes included changes in the Schiff Cold Air Sensitivity Scale, tactile sensitivity scores, patient satisfaction levels, the documentation of any adverse events, and the need for additional treatment during the 6-month period. To ensure objectivity, all clinical assessments and statistical analyses were performed by researchers who were fully blinded to the treatment allocations.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Samsun
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Samsun, Samsun, Turquía (Türkiye), 55270
- Ondokuz Mayıs University, Faculty of Dentistry, Department of Periodontology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients aged between 18 and 65 years.
- Presence of at least two hypersensitive teeth.
- Visual Analog Scale (VAS) score of 4 or higher (VAS >= 4) following stimulus.
- Schiff Cold Air Sensitivity Scale score of 2 or higher (Schiff >= 2).
- Presence of vital teeth in the target area.
- Patient is willing and able to provide written informed consent prior to study initiation.
Exclusion Criteria:
- Pregnancy or lactation.
- Presence of active periodontal disease in the target area.
- Teeth with dental caries, deep restorations, or cracked tooth syndrome.
- Endodontically treated teeth.
- History of allergy or hypersensitivity related to the materials, products, or chemical agents used in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group 1: Nd:YAG Laser
Participants assigned to this group received Nd:YAG laser application targeted at the hypersensitive teeth to achieve desensitization.
The procedure was completed during the treatment session according to the clinical protocol.
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Nd:YAG laser application performed for the treatment of dentine hypersensitivity.
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Experimental: Group 2: Diode Laser
Participants assigned to this group received Diode laser application on the affected dentine areas for hypersensitivity treatment.
The application was performed in accordance with the specified parameters.
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Diode laser application performed for the treatment of dentine hypersensitivity.
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Experimental: Group 3: Dentin Barrier Agent
Participants assigned to this group received a topical application of a herbal propolis-based dentin barrier agent onto the hypersensitive tooth surfaces.
The agent was applied to seal the dentinal tubules and reduce sensitivity.
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Topical application of a herbal propolis-based dentin barrier agent.
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Comparador falso: Group 4: Sham Application
Participants assigned to this group received a sham (placebo) procedure designed to completely simulate the laser or topical application experience without delivering any active laser energy or therapeutic desensitizing agent.
This group served as the control to account for the placebo effect.
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Placebo/sham procedure to simulate treatment without delivering active laser or therapeutic agent benefits
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Visual Analog Scale (VAS) Score after Air Stimulus
Periodo de tiempo: Baseline and 6 months
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Pain intensity evaluated using the Visual Analog Scale (VAS), where scores range from 0 (no pain) to 10 (extreme/worst pain).
The primary outcome is defined as the change in pain intensity in response to a controlled air blast stimulus from baseline to 6 months.
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Baseline and 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Schiff Cold Air Sensitivity Scale Score
Periodo de tiempo: Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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Dentine sensitivity assessed using the Schiff Cold Air Sensitivity Scale, where scores range from 0 (patient does not respond to air stimulus) to 3 (patient responds to air stimulus, experiences pain, and requests discontinuation of stimulus).
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Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
|
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Tactile Sensitivity Score
Periodo de tiempo: Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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Tactile sensitivity evaluated using a standard dental explorer probe passed across the affected dentine surface to record the presence or absence of discomfort or pain.
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Baseline, immediately post-treatment, 1 week, 1 month, 3 months, and 6 months
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Colaboradores e Investigadores
Patrocinador
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
- 2025000326-2
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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