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Evaluation of Sensitivity and Color Change of Different Protocols of In-office Dental Bleaching

12 de mayo de 2026 actualizado por: Marcos de Oliveira Barceleiro, Universidade Federal Fluminense
Clinical randomized single-blind trial, used to measure the level of tooth sensitivity (TS) after in-office dental bleaching sessions, on volunteers using a modified visual analog scale (VAS). The investigators selected for this study, 40 participants with color 2M2 or darker (Using OM1 - 5M3 Vita bleaching shade guide). The investigators performed two bleaching sessions with a 40% hydrogen peroxide gel with a 1-week interval. Participants were enrolled in two groups. In one group, the bleaching product was used according to manufacturer's instructions (40-minutes application in each section). In the other group, the bleaching product was used in two 20-minutes applications in each section.The investigators recorded the TS up to 48h with a VAS scale and the color at baseline and 30 days after bleaching with a value-oriented shade guide and a spectrophotometer. The risk and intensity of TS and the color change were compared between the two groups.

Descripción general del estudio

Descripción detallada

Two weeks before the bleaching procedures, selected volunteers from the city of Nova Friburgo, (Rio de Janeiro, Brazil) received a dental screening and a dental prophylaxis with pumice and water in a rubber cup and signed an informed consent form.

This was a randomized, single-blind (evaluators), parallel and equivalence trial with an equal allocation rate between groups.

A total of 71 participants were examined in a dental chair to check if they met the inclusion and exclusion criteria. A total of 40 participants were included in this study. The participants were randomly divided in the 40-minutes or 2x20-minutes groups.

During the in-office sessions, participants had the gingival tissue isolated of the teeth using a light-cured resin dam (Opal Dam, Ultradent Products International, Salt Lake, Utah, USA). After that, the 40% hydrogen peroxide gel (Opalescence Boost, Ultradent) was applied in one 40-min application according to the manufacturer's directions in all upper and lower incisors, canines and premolars, or was applied in the same teeth, but during 2 x 20-min applications, with no interval between them. After 20 minutes, the bleaching gel was removed with water spray before the second 20 minutes application. After 7 days this procedure was repeated using the same protocols.

Color evaluation was performed before and 30 days after the end of the bleaching treatment using a subjective (value oriented shade guide Vita Lumin, Vita Zahnfabrik, Bad Sackingen, Germany) and an objective method (Easyshade spectrophotometer, Vident, Brea, CA, USA). Color evaluation was done in a room under artificial lightning conditions without interference from outside light.

For the subjective examination, the shadeguide's 16 tabs were arranged from highest (B1) to lowest (C4) value. Changes in the scale were treated as representing a continuous and approximately linear ranking. Color was measured in the middle third of the facial surface of the right upper canine at baseline and 30 days after bleaching to calculate the variations in color towards the lighter end of the scale (Delta Shade Guide Units - DSGU).

One calibrated operator measured the color in all participants using the Vita Easyshade spectrophotomer (Easyshade, Vident, Brea, CA, USA) before and 30 days after the bleaching therapy. The L*, a* and b* parameters were recorded. L* represents the value from 0 (black) to 100 (white) and a* and b* represent the shade, where a* is the measurement along the red-green axis and b* is the measurement along the yellow-blue axis. Color change was calculated between the two assessment periods (DE) using the formula: DE = [(DL*)2 + (Da*)2 + (Db*)2]1/2.

The patients recorded their perception of TS during the first and second bleaching sessions using the visual analogue scale VAS. This scale employs a 10-cm horizontal line with words "no pain" at one end and "worst pain" at the opposite end. Participants recorded whether they experienced TS during the treatment up to 1 h after the bleaching, from 1 h to 24 hand from 24h to 48 h after bleaching. In the 30-day recall, patients were also asked if they experienced pain during this 30-day period. As two bleaching sessions were performed, the VAS score obtained in both bleaching sessions was considered for statistical purposes. These values

Tipo de estudio

Intervencionista

Inscripción (Actual)

40

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.

Ubicaciones de estudio

    • Rio de Janeiro
      • Nova Friburgo, Rio de Janeiro, Brasil, 28625-650
        • Universidade Federal Fluminense - School of Dentistry

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
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • The selected volunteers should:

    • Present Good general state of health
    • Be at least 18 years of age
    • Have an acceptable oral hygiene
    • Present the upper and lower arches without absence of teeth of first premolar right to the left first premolar.
    • Have anterior teeth with any kind of restoration.
    • Be No smoker
    • Have the upper right canine with color 2M2 or darker

Exclusion Criteria:

  • The selected volunteers should not:

    • Have medical history of diseases that can affect the results of the study
    • Have made use of cigarettes in the last 30 days
    • Have some important pathology in the oral cavity
    • Be pregnant
    • Be breastfeeding
    • Have moderate advanced periodontal disease;
    • Have consumed drugs, alcool or any medication that can cover the results, as other types of anti-inflammatories or painkillers;
    • Have used products indicated for dental sensitivity, as desensitizing toothpaste or similar product
    • Present gingival recession
    • Present exacerbated hypersensitivity history

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Bleaching 40 minutes
Patients will have their teeth bleached in-office using 40% Hydrogen Peroxide (commercial available product - Opalescence Boost, Ultradent Products International) in two sections with 7 days of interval between sections. In each section, the product will be used during 40 minutes according to manufacturer's instructions.
Patients will have their teeth bleached in-office using 40% Hydrogen Peroxide (commercial available product - Opalescence Boost, Ultradent Products International) in two sections with 7 days of interval between sections. In each section, the product will be used during 40 minutes according to manufacturer's instructions.
Experimental: Bleaching 2x20 minutes
Patients will have their teeth bleached in-office using 40% Hydrogen Peroxide (commercial available product - Opalescence Boost, Ultradent Products International) in two sections with 7 days of interval between sections. In each section, the product will be used during 20 minutes, will be removed (with water) and a new application of 20 minutes will be made.
Patients will have their teeth bleached in-office using 40% Hydrogen Peroxide (commercial available product - Opalescence Boost, Ultradent Products International) in two sections with 7 days of interval between sections. In each section, the product will be used during 20 minutes, will be removed with water, and another application of 20 minutes will be made.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Tooth sensitivity
Periodo de tiempo: 1 hour after dental bleaching session
Visual Analogic Scale (0-100) for Tooth Sensitivity. In this case, zero means no sensitivity (a better outcome and 100 means higher sensitivity (worse outcome).
1 hour after dental bleaching session
Tooth sensitivity
Periodo de tiempo: 24 hours after dental bleaching session
Visual Analogic Scale (0-100) for Tooth Sensitivity. In this case, zero means no sensitivity (a better outcome and 100 means higher sensitivity (worse outcome).
24 hours after dental bleaching session
Tooth sensitivity
Periodo de tiempo: 48 hours after dental bleaching session
Visual Analogic Scale (0-100) for Tooth Sensitivity. In this case, zero means no sensitivity (a better outcome and 100 means higher sensitivity (worse outcome).
48 hours after dental bleaching session

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Color change with scale
Periodo de tiempo: 30 days after dental bleaching session
Objective color evaluation comparing tooth color against a comercial color scale from A1 to D4
30 days after dental bleaching session
Color change with spectrophotometer
Periodo de tiempo: 30 days after dental bleaching session
Objective color evaluation using a spectrophotometer
30 days after dental bleaching session

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: MARCOS O BARCELEIRO, PhD, Full Professor

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

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 (Actual)

1 de octubre de 2025

Finalización primaria (Actual)

20 de enero de 2026

Finalización del estudio (Estimado)

30 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de mayo de 2026

Publicado por primera vez (Actual)

19 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • UFFBleachingProtocols

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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