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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Bone Regeneration
• Intervention / Treatment: Device: Membrane Jason MB GmbH Non-cross-linked (NCL); Device: Membrane BioMend Extend Glutaraldehyde cross-linked; Device: Membrane OSSIX Agile Ribose cross-linked (RCL)

Detailed Description

The study was designed as a double-blinded, single-center, randomized clinical trial. Three different types of collagen membranes, ribose cross-linked (RCL) OSSIX Agile, glutaraldehyde cross-linked (GCL) - BioMend Extend, and non-cross-linked (NCL) Jason MB GmbH, were selected for the study.

During the first visit, digital intraoral impressions and clinical pictures will be taken, periodontal charts filled, and oral hygiene sessions conducted by trained hygienists. Two weeks later, during the second visit, patients will be reexamined to exclude any signs of inflammation. Membranes will be cut to a uniform size of 8*10 mm by an assistant prior to placement. They will be placed in a randomized mesiodistal order on the buccal mucosa, apical to the gingival margins of maxillary premolar and molar teeth (the future position will be evaluated on the intraoral scanned model). To fix the membranes, a vestibular sling suture without any perforation (PTFE 3/0) will be used. A light-cured periodontal dressing (Barricaid, Dentsply Caulk, Dentsply Int. Inc., York, PA, USA) will be placed on the buccal site to fix a knot and two other points on the membrane to fix it to the suture. Standard intraoral pictures will be taken. Patients will be instructed to avoid hard foods, brushing in the area of the membrane, and excessive movements to prevent dislocation of the structure. The same oral hygiene products will be provided to all patients.

Follow-up visits will be scheduled at 3, 7 and 10 days. At the 10-day follow-up clinical evaluation will be performed to assess any perforation. A set of pictures will be taken. Membranes integrity will be analyzed by two blinded examiners using a Scale.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh, School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ≥ 18 years old
• Good overall health (ASA I or ASA II)
• Good oral health

Exclusion Criteria:

• Patients with gingival pathologies
• Individuals with uncontrolled chronic diseases or immunocompromised.
• Pregnant Patients
• Patients who are currently breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: OSSIX - BioMend - Jason; Possible unique ordering of the 3 different membranes to which participants may be randomized	Device: Membrane Jason MB GmbH Non-cross-linked (NCL); The membrane will be stabilized in the oral mucosa using sutures and flowable composite.; Device: Membrane BioMend Extend Glutaraldehyde cross-linked; The membrane will be stabilized in the oral mucosa using sutures and flowable composite.; Device: Membrane OSSIX Agile Ribose cross-linked (RCL); The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
Active Comparator: BioMend - OSSIX - Jason; Possible unique ordering of the 3 different membranes to which participants may be randomized	Device: Membrane Jason MB GmbH Non-cross-linked (NCL); The membrane will be stabilized in the oral mucosa using sutures and flowable composite.; Device: Membrane BioMend Extend Glutaraldehyde cross-linked; The membrane will be stabilized in the oral mucosa using sutures and flowable composite.; Device: Membrane OSSIX Agile Ribose cross-linked (RCL); The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
Active Comparator: BioMend - Jason - OSSIX; Possible unique ordering of the 3 different membranes to which participants may be randomized	Device: Membrane Jason MB GmbH Non-cross-linked (NCL); The membrane will be stabilized in the oral mucosa using sutures and flowable composite.; Device: Membrane BioMend Extend Glutaraldehyde cross-linked; The membrane will be stabilized in the oral mucosa using sutures and flowable composite.; Device: Membrane OSSIX Agile Ribose cross-linked (RCL); The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
Active Comparator: Jason - OSSIX - BioMend; Possible unique ordering of the 3 different membranes to which participants may be randomized	Device: Membrane Jason MB GmbH Non-cross-linked (NCL); The membrane will be stabilized in the oral mucosa using sutures and flowable composite.; Device: Membrane BioMend Extend Glutaraldehyde cross-linked; The membrane will be stabilized in the oral mucosa using sutures and flowable composite.; Device: Membrane OSSIX Agile Ribose cross-linked (RCL); The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
Active Comparator: Jason - BioMend - OSSIX; Possible unique ordering of the 3 different membranes to which participants may be randomized	Device: Membrane Jason MB GmbH Non-cross-linked (NCL); The membrane will be stabilized in the oral mucosa using sutures and flowable composite.; Device: Membrane BioMend Extend Glutaraldehyde cross-linked; The membrane will be stabilized in the oral mucosa using sutures and flowable composite.; Device: Membrane OSSIX Agile Ribose cross-linked (RCL); The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
Active Comparator: OSSIX - Jason - BioMend; Possible unique ordering of the 3 different membranes to which participants may be randomized	Device: Membrane Jason MB GmbH Non-cross-linked (NCL); The membrane will be stabilized in the oral mucosa using sutures and flowable composite.; Device: Membrane BioMend Extend Glutaraldehyde cross-linked; The membrane will be stabilized in the oral mucosa using sutures and flowable composite.; Device: Membrane OSSIX Agile Ribose cross-linked (RCL); The membrane will be stabilized in the oral mucosa using sutures and flowable composite.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 and 7 days

Collaborators and Investigators

• Sponsor: Andrea Ravida
• Collaborators: Dentsply Sirona Inc.
• Investigators: Principal Investigator: Andrea Ravida, DDS, MS, PhD, Program Director of the Periodontics and Implant Dentistry Department

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cross linked membrane; non cross linked membrane; degradation rate
• Additional Relevant MeSH Terms: Anti-Infective Agents; Disinfectants; Glutaral
• Other Study ID Numbers: STUDY24100119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No