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

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.

Study Overview

• Status: Completed
• Conditions: Tissue Adhesives
• Intervention / Treatment: Other: Secure Adhesive Regular,; Other: Secure Adhesive Extra Strength; Other: Daro Adhesive Regular; Other: Daro Adhesive Hydrobond; Other: Pros-Aide Adhesive

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Other: Secure Adhesive Regular,; 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.; Other: Secure Adhesive Extra Strength; 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.; Other: Daro Adhesive Regular; 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.; Other: Daro Adhesive Hydrobond; 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.; Other: Pros-Aide Adhesive; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of adhesive residue remaining on skin after 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adhesive Failure Mode Classification	Assessment of adhesive failure mode following removal of the silicone strip. Failure mode will be classified as: Adhesive failure (failure at skin-adhesive interface); Cohesive failure (failure within adhesive layer); 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)	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	Comparison of percentage adhesive residue remaining on skin between silicone-based and water-based adhesive formulations, measured using gravimetric analysis.	8 hours

Collaborators and Investigators

• Sponsor: Amrita Vishwa Vidyapeetham

Publications and helpful links

General Publications

• McNichol L, Lund C, Rosen T, Gray M. Medical adhesives and patient safety: state of the science: consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries. Orthop Nurs. 2013 Sep-Oct;32(5):267-81. doi: 10.1097/NOR.0b013e3182a39caf.
• Rajasekaran R, Chander NG, Reddy JR, Balasubramanium M. Estimation of differences and reapplication effect of peel bond strength between silicone-based and water-based adhesives. J Prosthet Dent. 2024 Jun;131(6):1276-1279. doi: 10.1016/j.prosdent.2022.05.024. Epub 2022 Jun 25.
• Kiat-amnuay S, Gettleman L, Khan Z, Goldsmith LJ. Effect of adhesive retention on maxillofacial prostheses. Part I: skin dressings and solvent removers. J Prosthet Dent. 2000 Sep;84(3):335-40. doi: 10.1067/mpr.2000.109507.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Actual): December 1, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: May 25, 2026
• First Submitted That Met QC Criteria: June 9, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Skin irritation; tissue adhesives; Maxillofacial prosthesis; Adhesive residue; Silicone prosthesis; Medical adhesive-related skin injury; Silicone-based adhesive; Water-based adhesive; Maxillofacial rehabilitation; Prosthetic adhesive
• Other Study ID Numbers: ECASM-AIMS-2024-085

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes