Comparative Study of Three Collagen Membranes: 1 Non-cross-linked and 2 Cross-linked
Comparative Analysis of Three Types of Collagen Membranes Exposed to the Oral Environment: a Randomized Clinical Trial
1 other identifier
interventional
20
1 country
1
Brief Summary
This study is being done to compare how quickly three different types of collagen membranes break down when they are exposed to the mouth. These membranes are often used in dental and oral surgery to help with healing and tissue growth. The goal is to find out if one membrane lasts longer than the others, which may help doctors choose the best option for different procedures. In this study, the membranes will be placed in the mouth in a specific area near the gums of the upper back teeth. The study is designed so that neither the patients nor the researchers evaluating the results will know which membrane is which (this is called a double-blind study). Over time, researchers will measure how much each membrane has broken down. This information may help improve treatment planning and patient outcomes in dental care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2025
CompletedFirst Posted
Study publicly available on registry
April 25, 2025
CompletedStudy Start
First participant enrolled
April 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
February 17, 2026
February 1, 2026
1.3 years
April 17, 2025
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Degradation rates of three different collagen membranes simulating exposure to the oral environment.
Membrane integrity will be analyzed by two blinded examiners through photographs, using a scale from 0 to 5 where 0 means integrity and 5 represents complete resorption.
10 days
Secondary Outcomes (1)
Degradation rates of three different collagen membranes simulating exposure to the oral environment.
3 and 7 days
Study Arms (6)
OSSIX - BioMend - Jason
ACTIVE COMPARATORPossible unique ordering of the 3 different membranes to which participants may be randomized
BioMend - OSSIX - Jason
ACTIVE COMPARATORPossible unique ordering of the 3 different membranes to which participants may be randomized
BioMend - Jason - OSSIX
ACTIVE COMPARATORPossible unique ordering of the 3 different membranes to which participants may be randomized
Jason - OSSIX - BioMend
ACTIVE COMPARATORPossible unique ordering of the 3 different membranes to which participants may be randomized
Jason - BioMend - OSSIX
ACTIVE COMPARATORPossible unique ordering of the 3 different membranes to which participants may be randomized
OSSIX - Jason - BioMend
ACTIVE COMPARATORPossible unique ordering of the 3 different membranes to which participants may be randomized
Interventions
The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
Eligibility Criteria
You may qualify if:
- ≥ 18 years old
- Good overall health (ASA I or ASA II)
- Good oral health
You may not qualify if:
- Patients with gingival pathologies
- Individuals with uncontrolled chronic diseases or immunocompromised.
- Pregnant Patients
- Patients who are currently breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andrea Ravidalead
- Dentsply Sirona Inc.collaborator
Study Sites (1)
University of Pittsburgh, School of Dental Medicine
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
Klinger A, Asad R, Shapira L, Zubery Y. In vivo degradation of collagen barrier membranes exposed to the oral cavity. Clin Oral Implants Res. 2010 Aug;21(8):873-6. doi: 10.1111/j.1600-0501.2010.01921.x.
PMID: 20666799BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Ravida, DDS, MS, PhD
Program Director of the Periodontics and Implant Dentistry Department
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor and Program director
Study Record Dates
First Submitted
April 17, 2025
First Posted
April 25, 2025
Study Start
April 28, 2025
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share