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Quantifying Adhesive Residue on Skin Following Removal of Maxillofacial Prosthetic Adhesives: An In Vivo Study (ARMS)

9 de junio de 2026 actualizado por: Dr Kashyap Sawant, Amrita Vishwa Vidyapeetham

A Comparative Assessment of Adhesive Residue on the Skin Following the Removal of Extraoral Silicone Prosthesis: An In Vivo Study

This pilot interventional in vivo study aims to quantitatively evaluate and compare the amount of adhesive residue left on the skin following removal of extraoral maxillofacial prosthetic adhesives. Five commercially available adhesives will be tested using standardized silicone strips applied to randomized sites on the forearms of healthy volunteers. After 8 hours of wear, the strips will be removed, and adhesive residue will be quantified using gravimetric analysis based on differences in strip weight before and after removal. The study also aims to evaluate adhesive failure modes and compare the cleanability of silicone-based and water-based adhesives. Findings from this study may help clinicians select adhesives that optimize prosthesis retention while minimizing skin irritation and patient burden.

Descripción general del estudio

Descripción detallada

This pilot interventional in vivo study is designed to quantitatively evaluate and compare the amount of adhesive residue left on the skin following removal of extraoral maxillofacial prosthetic adhesives. Adhesive-retained facial prostheses are widely used in maxillofacial rehabilitation; however, residual adhesive remaining on the skin after prosthesis removal may contribute to patient discomfort, skin irritation, and difficulty in daily prosthesis maintenance. Despite its clinical importance, adhesive residue has not been quantitatively evaluated in vivo.

Five commercially available maxillofacial prosthetic adhesives, including silicone-based and water-based formulations, will be evaluated using standardized silicone elastomer strips. Five healthy volunteers between 18 and 30 years of age will be recruited. Thirty test sites will be prepared on the volar surfaces of the forearms, with six sites allocated to each adhesive group through block randomization. Participants with skin diseases, adhesive allergies, systemic conditions affecting skin integrity, pregnancy, lactation, or recent skin injuries will be excluded.

Standardized silicone strips measuring 60 × 20 × 3 mm will be fabricated and coated with a uniform quantity of adhesive. After a drying period of 3 minutes, the strips will be applied to designated skin sites and maintained for 8 hours during normal daily activities. Following removal, the strips will be reweighed using a high-precision analytical balance. Adhesive residue remaining on the skin will be quantified using gravimetric analysis by calculating the percentage difference between initial and final strip weights.

The primary outcome measure is the percentage of adhesive residue remaining on the skin after removal of the prosthetic adhesive. Secondary objectives include assessment of adhesive failure modes and comparison of residue patterns between silicone-based and water-based adhesive systems.

To minimize bias, participant allocation sites will be randomized and both participants and investigators involved in application and evaluation procedures will remain blinded to adhesive identity. Statistical analysis will be performed using one-way analysis of variance followed by post hoc multiple comparison testing. The findings of this study may help clinicians select adhesive systems that optimize prosthesis retention while minimizing skin trauma and patient burden during long-term maxillofacial rehabilitation.

Tipo de estudio

Intervencionista

Inscripción (Actual)

5

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

    • Kerala
      • Kochi, Kerala, India, 682041
        • Amrita School of Dentistry, Amrita Institute of Medical Sciences, Kochi, Kerala, India

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

Sí

Descripción

Inclusion Criteria:

  • Healthy volunteers aged 18-30 years
  • Willingness to participate and provide written informed consent
  • No history of skin disease
  • No known adhesive allergy

Exclusion Criteria:

  • Age below 18 years or above 30 years
  • Current use of medications affecting skin integrity or immune function
  • Recent skin trauma, surgery, or active skin lesions
  • Existing systemic disease affecting skin health
  • Pre-existing dermatological conditions
  • Pregnancy or lactation
  • Known allergy or hypersensitivity to adhesives or silicone materials
  • Participation in another clinical trial during the study period

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: Otro
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Adhesive Evaluation Group
All participants receive applications of five commercially available maxillofacial prosthetic adhesives at randomized skin sites on the volar forearms using standardized silicone strips. Adhesive residue remaining on the skin after 8 hours of wear is quantitatively evaluated using gravimetric analysis.
Silicone-based maxillofacial prosthetic adhesive (Factor II Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
Silicone-based maxillofacial prosthetic adhesive (Factor II Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
Water-based maxillofacial prosthetic adhesive (Factor II Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
Water-based maxillofacial prosthetic adhesive (Factor II Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.
Water-based maxillofacial prosthetic adhesive (ADM Tronics Inc., USA) evaluated for adhesive residue remaining on skin following removal of standardized silicone strips after 8 hours of wear.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of adhesive residue remaining on skin after 8 hours
Periodo de tiempo: 8 hours
Quantitative assessment of adhesive residue remaining on the skin after removal of standardized silicone strips coated with maxillofacial prosthetic adhesives using gravimetric analysis.
8 hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adhesive Failure Mode Classification
Periodo de tiempo: 8 hours

Assessment of adhesive failure mode following removal of the silicone strip. Failure mode will be classified as:

  1. Adhesive failure (failure at skin-adhesive interface)
  2. Cohesive failure (failure within adhesive layer)
  3. Mixed failure (combination of adhesive and cohesive failure)

Classification will be performed by visual inspection of the skin and silicone strip after removal.

8 hours
Time Required for Complete Adhesive Removal (Cleanability Assessment)
Periodo de tiempo: 8 hours
Cleanability will be assessed by measuring the time (in seconds) required to completely remove residual adhesive from the skin using a standardized cleaning procedure. Lower cleaning times indicate greater cleanability.
8 hours
Comparison of Adhesive Residue Between Silicone-Based and Water-Based Adhesives
Periodo de tiempo: 8 hours
Comparison of percentage adhesive residue remaining on skin between silicone-based and water-based adhesive formulations, measured using gravimetric analysis.
8 hours

Colaboradores e Investigadores

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

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)

20 de febrero de 2024

Finalización primaria (Actual)

1 de diciembre de 2025

Finalización del estudio (Actual)

31 de diciembre de 2025

Fechas de registro del estudio

Enviado por primera vez

25 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de junio de 2026

Publicado por primera vez (Actual)

15 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de junio de 2026

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

9 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data (IPD) will not be shared because the study involves a very small sample size, and de-identification may not fully protect participant confidentiality. Data will be retained by the investigators and may be made available for academic review upon reasonable request, subject to institutional ethics and data protection policies.

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

producto fabricado y exportado desde los EE. UU.

Sí

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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