Effects of an Experimental Propolis Gel on Tooth Sensitivity Control and Post-bleaching Color Change: a Randomized Clinical Trial
29 de abril de 2026 actualizado por: Cecy Martins Silva, Universidade Federal do Para
Effects of a 0.5% Experimental Propolis Gel on Tooth Sensitivity Control and Post-bleaching Color Change: a Randomized Clinical Trial
This randomized, parallel, double-blind, placebo-controlled clinical study aims to investigate the effects of an experimental 0.5% propolis gel on controlling tooth sensitivity and discoloration after in-office dental bleaching.
Sixty-six volunteers will be selected according to inclusion and exclusion criteria and will be randomly assigned to three experimental groups: Placebo - received application of a gel without active ingredient (K-Y Original), KF2 - received application of 5% potassium nitrate and 2% sodium fluoride (Desensitize KF 2%), and Propolis 0.5% - application of the experimental 0.5% propolis gel.
All participants will undergo two in-office bleaching sessions with 35% hydrogen peroxide, with seven-day intervals between them.
The bleaching agent will be applied for 30 minutes.
The desensitizing agents will be applied prior to bleaching and kept in contact with the vestibular dental surface for ten minutes.
Sensitivity will be monitored daily using the Visual Analogue Scale for fourteen days, while color change will be determined by spectrophotometry, using the parameters of the CIELab* system and calculation of ΔE00, measured before bleaching (T0) and 7 days after the second bleaching session (T1).
The data will be subjected to statistical analysis according to sample distribution, adopting a power of 80% and a significance level of 5%.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
All groups will undergo in-office whitening treatment, carried out in 2 sessions with a 7-day interval, according to the steps described below:
Prophylaxis; Application of gingival barrier; Application of desensitizing agent or placebo, according to the established groups; Handling of the whitening material following the manufacturer's instructions: application of Whiteness HP 35% whitening gel for 30 minutes Final removal of the whitening gel and gingival barrier, followed by rinsing with water.
The application of the desensitizing agent or its placebo will follow this sequence:
Relative isolation with cotton rolls; Active application of the product on the buccal surfaces of all teeth using a rubber cup for 10 minutes; Rinsing with water.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
66
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.
Estudio Contacto
- Nombre: Cecy M Silva, Doctor
- Número de teléfono: +55 (91) 3201-7563
- Correo electrónico: cecymsilva@gmail.com
Ubicaciones de estudio
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Pará
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Belém, Pará, Brasil, 66075-110
- UFPA
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Contacto:
- University F Para
- Número de teléfono: 55(91) 3201-7390
- Correo electrónico: ppgo@ufpa.br
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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
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- good oral hygiene
- absence of active caries lesions
- never having previous whitening therapy
- not present dental hypersensitivity
- don't be a smoker
- not be pregnant
- present at least 28 teeth in the oral cavity.
Exclusion Criteria:
- volunteers who were under orthodontic treatment,
- presence of periodontal disease
- dental cracks or fractures
- restorations and prostheses on anterior teeth
- extensive molar restorations
- gastroesophageal disorders
- severe internal dental darkening
- presence of dentinal exposure in anterior and/or posterior teeth.
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 |
|---|---|
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Comparador de placebos: Placebo- KY original gel
The Placebo group received the application of placebo gel for post tooth bleaching sensitivity.
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Prior to bleaching treatment with 35% hydrogen peroxide, the Placebo group received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel.
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Comparador activo: KF2- Potassium nitrate
The KF2 group received the application of potassium nitrate for post tooth bleaching sensitivity.
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Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the KF2 received application of the potassium nitrate gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, for 10 minutes.
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Experimental: Propolis- Propolis 0,5% gel
The Propolis group received the application of experimental gel of propolis 0,5% for post tooth bleaching sensitivity.
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Prior to bleaching treatment with 35% hydrogen peroxide, the dental elements of the Propolis received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, for 10 minutes.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Post-whitening sensitivity assessment
Periodo de tiempo: 14 days
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To assess post-operative sensitivity, patients will be instructed to fill out a form to record daily tooth sensitivity during the 14 days of treatment, based on their individual perception of pain.
This form will be handed out at each whitening session and returned to the researcher at the following session, that is, always one week after each whitening session.
The assessment form will consist of a visual analogue scale (VAS).
This scale consists of a 10 cm horizontal line with scores of 0 and 10 at its ends, where 0 means no sensitivity and 10 means severe tooth sensitivity.
The patient will be instructed to draw a vertical line along the horizontal line of the scale, recording the intensity of tooth sensitivity per day.
So that the distance in millimeters from the zero end can later be measured with the aid of a millimeter ruler, thus obtaining the patient's pain intensity level.
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14 days
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Color evaluation
Periodo de tiempo: Baseline (T0) and one week after the 2rd whitening session (T1)
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The VITA Easyshade spectrophotometer (VITA Zahnfabrik, Bad Säckingen, Germany) will be used to measure the color, where the area of dental correspondence to be evaluated will be the middle third of the vestibular surface of the upper canines.
To standardize the color readings, silicone matrices will be made, where the impression will be extended from canine to canine.
A window will be created on the vestibular surface of each canine of the silicone guide using a metal device with a radius of 6 mm, corresponding to the diameter of the spectrophotometer tip.
Thus, the tip of the device will be inserted into the silicone guide to obtain the color parameters.
Subsequently, the color difference between the baseline (T0) and one week after the 2rd bleaching session (T1) will be calculated using the CIEDE2000 formulas (ΔE00).
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Baseline (T0) and one week after the 2rd whitening session (T1)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
29 de abril de 2026
Finalización primaria (Estimado)
30 de diciembre de 2026
Finalización del estudio (Estimado)
30 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
29 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 93881125.4.0000.0018
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.
No
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