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

NCT07647458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2026-06-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Amrita Vishwa Vidyapeetham

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2025-12-01
Completion
2025-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07647458 on ClinicalTrials.gov