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

NCT07647458 | Completed

• 1 other identifier: ECASM-AIMS-2024-085
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adhesive Failure Mode Classification

  8 hours

• Time Required for Complete Adhesive Removal (Cleanability Assessment)

  8 hours

• Comparison of Adhesive Residue Between Silicone-Based and Water-Based Adhesives

  8 hours

Study Arms (1)

Adhesive Evaluation Group

EXPERIMENTAL

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

Interventions

Secure Adhesive Regular, OTHER

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.

Adhesive Evaluation Group

Secure Adhesive Extra Strength OTHER

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.

Adhesive Evaluation Group

Daro Adhesive Regular OTHER

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.

Adhesive Evaluation Group

Daro Adhesive Hydrobond OTHER

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.

Adhesive Evaluation Group

Pros-Aide Adhesive OTHER

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.

Adhesive Evaluation Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amrita Vishwa Vidyapeetham: lead

Study Sites (1)

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

Kochi, Kerala, 682041, India

Location

Related Publications (3)

• 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.

  PMID: 24022422 BACKGROUND

• 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.

  PMID: 35764450 BACKGROUND

• 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.

  PMID: 11005907 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants and outcome assessors were blinded to adhesive identity. Adhesive allocation was coded during outcome assessment to minimize bias
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRIMARY INVESTIGATOR

Model Details: 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.

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 15, 2026
• Study Start: February 20, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)