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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07647458
Acronym
ARMS
Enrollment
5
Registered
2026-06-15
Start date
2024-02-20
Completion date
2025-12-31
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tissue Adhesives

Keywords

tissue adhesives, Maxillofacial prosthesis, Adhesive residue, Silicone prosthesis, Skin irritation, Medical adhesive-related skin injury, Silicone-based adhesive, Water-based adhesive, Maxillofacial rehabilitation, Prosthetic adhesive

Brief summary

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.

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.

Interventions

OTHERSecure 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.

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.

OTHERPros-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.

Sponsors

Amrita Vishwa Vidyapeetham
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Masking description

Participants and outcome assessors were blinded to adhesive identity. Adhesive allocation was coded during outcome assessment to minimize bias

Intervention model description

This is a single-group interventional pilot study in which each participant receives all five adhesive interventions at randomized skin sites on the volar forearms. Standardized silicone strips coated with different maxillofacial prosthetic adhesives are applied for 8 hours, and adhesive residue is quantitatively assessed using gravimetric analysis.

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of adhesive residue remaining on skin after 8 hours8 hoursQuantitative assessment of adhesive residue remaining on the skin after removal of standardized silicone strips coated with maxillofacial prosthetic adhesives using gravimetric analysis.

Secondary

MeasureTime frameDescription
Adhesive Failure Mode Classification8 hoursAssessment 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.
Time Required for Complete Adhesive Removal (Cleanability Assessment)8 hoursCleanability 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.
Comparison of Adhesive Residue Between Silicone-Based and Water-Based Adhesives8 hoursComparison of percentage adhesive residue remaining on skin between silicone-based and water-based adhesive formulations, measured using gravimetric analysis.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026