Tissue AdhesivesARMSNCT07647458
Quantifying Adhesive Residue on Skin Following Removal of Maxillofacial Prosthetic Adhesives: An In Vivo Study
A study testing Secure Adhesive Regular,, Secure Adhesive Extra Strength and Daro Adhesive Regular in people with Tissue Adhesives, run by Amrita Vishwa Vidyapeetham at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Tissue Adhesives
- What is being tested?
- Secure Adhesive Regular,, Secure Adhesive Extra Strength and Daro Adhesive Regular
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIndia
- Study dates
- 20 Feb 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 18-30 years
- Willingness to participate and provide written informed consent
- No history of skin disease
- No known adhesive allergy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Amrita School of Dentistry, Amrita Institute of Medical Sciences, Kochi, Kerala, India
Kochi, Kerala, 682041
About this study
Official title: 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.
Read the 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.
- Conditions
- Tissue Adhesives
- Being tested
- Secure Adhesive Regular,, Secure Adhesive Extra Strength, Daro Adhesive Regular, Daro Adhesive Hydrobond, Pros-Aide Adhesive
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Secure Adhesive Extra StrengthOther
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.
Daro Adhesive RegularOther
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.
Daro Adhesive HydrobondOther
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.
Pros-Aide AdhesiveOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Secure Adhesive Regular,; Other: Secure Adhesive Extra Strength; Other: Daro Adhesive Regular; Other: Daro Adhesive Hydrobond; Other: Pros-Aide Adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hours
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start20 Feb 2024
- Primary completion1 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tissue AdhesivesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amrita Vishwa Vidyapeetham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Kashyap Sawant, Amrita Vishwa Vidyapeetham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647458
- Sponsor's protocol ID
- ECASM-AIMS-2024-085
- Acronym
- ARMS
- Status last verified
- Jun 2026
- First submitted
- 25 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 24022422Rajasekaran 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.
PubMed 35764450Kiat-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.
PubMed 11005907
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Assessment of Adhesive Residue on the Skin Following the Removal of Extraoral Silicone Prosthesis: An In Vivo Study
- ClinicalTrials.gov ID
- NCT07647458
- Acronym / sponsor ID
- ARMS / ECASM-AIMS-2024-085
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Amrita Vishwa VidyapeethamUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Adhesive Evaluation Group | Experimental | Other: Secure Adhesive Regular,, Other: Secure Adhesive Extra Strength, Other: Daro Adhesive Regular, Other: Daro Adhesive Hydrobond, Other: Pros-Aide AdhesiveAll 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers aged 18-30 years
- Willingness to participate and provide written informed consent
- No history of skin disease
- No known adhesive allergy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Adhesive Evaluation Group |
| Secure Adhesive Extra StrengthSilicone-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 | Adhesive Evaluation Group |
| Daro Adhesive RegularWater-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 | Adhesive Evaluation Group |
| Daro Adhesive HydrobondWater-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 | Adhesive Evaluation Group |
| Pros-Aide AdhesiveWater-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. | Other | Adhesive Evaluation Group |
Primary outcome
Percentage of adhesive residue remaining on skin after 8 hours
Time frame: 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.
3 secondary outcomes
Adhesive Failure Mode Classification
Time frame: 8 hours
Time Required for Complete Adhesive Removal (Cleanability Assessment)
Time frame: 8 hours
Comparison of Adhesive Residue Between Silicone-Based and Water-Based Adhesives
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 24022422McNichol 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.
- Background: PubMed 35764450Rajasekaran 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.
- Background: PubMed 11005907Kiat-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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Secure Adhesive Regular,, Secure Adhesive Extra Strength and Daro Adhesive Regular in people with Tissue Adhesives, run by Amrita Vishwa Vidyapeetham at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of adhesive residue remaining on skin after 8 hours (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07647458, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.