Bone RegenerationNCT06944639
Comparative Study of Three Collagen Membranes: 1 Non-cross-linked and 2 Cross-linked
A study testing Membrane Jason MB GmbH Non-cross-linked (NCL), Membrane BioMend Extend Glutaraldehyde cross-linked and Membrane OSSIX Agile Ribose cross-linked (RCL) in people with Bone Regeneration, run by Andrea Ravida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Regeneration
- What is being tested?
- Membrane Jason MB GmbH Non-cross-linked (NCL), Membrane BioMend Extend Glutaraldehyde cross-linked and Membrane OSSIX Agile Ribose cross-linked (RCL)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to 25 Jun 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Good overall health (ASA I or ASA II)
- Good oral health
Who cannot join
- Patients with gingival pathologies
- Individuals with uncontrolled chronic diseases or immunocompromised.
- Pregnant Patients
- Patients who are currently breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh, School of Dental Medicine
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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.
- Conditions
- Bone Regeneration
- Being tested
- Membrane Jason MB GmbH Non-cross-linked (NCL), Membrane BioMend Extend Glutaraldehyde cross-linked, Membrane OSSIX Agile Ribose cross-linked (RCL)
- Keywords
- cross linked membrane, non cross linked membrane, degradation rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Membrane Jason MB GmbH Non-cross-linked (NCL)Device
The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
Membrane BioMend Extend Glutaraldehyde cross-linkedDevice
The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
Membrane OSSIX Agile Ribose cross-linked (RCL)Device
The membrane will be stabilized in the oral mucosa using sutures and flowable composite.
| Study group | Role | What they receive |
|---|---|---|
| OSSIX - BioMend - Jason | Active comparator | Possible unique ordering of the 3 different membranes to which participants may be randomized Receives: Device: Membrane Jason MB GmbH Non-cross-linked (NCL); Device: Membrane BioMend Extend Glutaraldehyde cross-linked; Device: Membrane OSSIX Agile Ribose cross-linked (RCL) |
| BioMend - OSSIX - Jason | Active comparator | Possible unique ordering of the 3 different membranes to which participants may be randomized Receives: Device: Membrane Jason MB GmbH Non-cross-linked (NCL); Device: Membrane BioMend Extend Glutaraldehyde cross-linked; Device: Membrane OSSIX Agile Ribose cross-linked (RCL) |
| BioMend - Jason - OSSIX | Active comparator | Possible unique ordering of the 3 different membranes to which participants may be randomized Receives: Device: Membrane Jason MB GmbH Non-cross-linked (NCL); Device: Membrane BioMend Extend Glutaraldehyde cross-linked; Device: Membrane OSSIX Agile Ribose cross-linked (RCL) |
| Jason - OSSIX - BioMend | Active comparator | Possible unique ordering of the 3 different membranes to which participants may be randomized Receives: Device: Membrane Jason MB GmbH Non-cross-linked (NCL); Device: Membrane BioMend Extend Glutaraldehyde cross-linked; Device: Membrane OSSIX Agile Ribose cross-linked (RCL) |
| Jason - BioMend - OSSIX | Active comparator | Possible unique ordering of the 3 different membranes to which participants may be randomized Receives: Device: Membrane Jason MB GmbH Non-cross-linked (NCL); Device: Membrane BioMend Extend Glutaraldehyde cross-linked; Device: Membrane OSSIX Agile Ribose cross-linked (RCL) |
| OSSIX - Jason - BioMend | Active comparator | Possible unique ordering of the 3 different membranes to which participants may be randomized Receives: Device: Membrane Jason MB GmbH Non-cross-linked (NCL); Device: Membrane BioMend Extend Glutaraldehyde cross-linked; Device: Membrane OSSIX Agile Ribose cross-linked (RCL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 days
Secondary 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.
Measured: 3 and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start28 Apr 2025
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone RegenerationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will receive the three membranes, placed randomly in different positions
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea Ravida
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Inc.
- Responsible party
- Sponsor-investigator, Andrea Ravida, University of Pittsburgh
- Investigators
- Andrea Ravida, DDS, MS, PhD, Principal investigator, Program Director of the Periodontics and Implant Dentistry Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944639
- Sponsor's protocol ID
- STUDY24100119
- Status last verified
- Aug 2026
- First submitted
- 17 Apr 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 20666799
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Three Types of Collagen Membranes Exposed to the Oral Environment: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06944639
- Acronym / sponsor ID
- STUDY24100119
- Conditions
- Bone Regeneration
- Keywords
- cross linked membrane, non cross linked membrane, degradation rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Andrea RavidaUniversity, hospital or other
- Collaborators
- Dentsply Sirona Inc.
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 25 Apr 2025 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 6
- Model description
- All patients will receive the three membranes, placed randomly in different positions
| Arm | Type | Receives |
|---|---|---|
| OSSIX - BioMend - Jason | Active comparator | Device: Membrane Jason MB GmbH Non-cross-linked (NCL), Device: Membrane BioMend Extend Glutaraldehyde cross-linked, Device: Membrane OSSIX Agile Ribose cross-linked (RCL)Possible unique ordering of the 3 different membranes to which participants may be randomized |
| BioMend - OSSIX - Jason | Active comparator | Device: Membrane Jason MB GmbH Non-cross-linked (NCL), Device: Membrane BioMend Extend Glutaraldehyde cross-linked, Device: Membrane OSSIX Agile Ribose cross-linked (RCL)Possible unique ordering of the 3 different membranes to which participants may be randomized |
| BioMend - Jason - OSSIX | Active comparator | Device: Membrane Jason MB GmbH Non-cross-linked (NCL), Device: Membrane BioMend Extend Glutaraldehyde cross-linked, Device: Membrane OSSIX Agile Ribose cross-linked (RCL)Possible unique ordering of the 3 different membranes to which participants may be randomized |
| Jason - OSSIX - BioMend | Active comparator | Device: Membrane Jason MB GmbH Non-cross-linked (NCL), Device: Membrane BioMend Extend Glutaraldehyde cross-linked, Device: Membrane OSSIX Agile Ribose cross-linked (RCL)Possible unique ordering of the 3 different membranes to which participants may be randomized |
| Jason - BioMend - OSSIX | Active comparator | Device: Membrane Jason MB GmbH Non-cross-linked (NCL), Device: Membrane BioMend Extend Glutaraldehyde cross-linked, Device: Membrane OSSIX Agile Ribose cross-linked (RCL)Possible unique ordering of the 3 different membranes to which participants may be randomized |
| OSSIX - Jason - BioMend | Active comparator | Device: Membrane Jason MB GmbH Non-cross-linked (NCL), Device: Membrane BioMend Extend Glutaraldehyde cross-linked, Device: Membrane OSSIX Agile Ribose cross-linked (RCL)Possible unique ordering of the 3 different membranes to which participants may be randomized |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old
- Good overall health (ASA I or ASA II)
- Good oral health
Key exclusion criteria (4 listed)
- Patients with gingival pathologies
- Individuals with uncontrolled chronic diseases or immunocompromised.
- Pregnant Patients
- Patients who are currently breastfeeding
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 |
|---|---|---|
| Membrane Jason MB GmbH Non-cross-linked (NCL)The membrane will be stabilized in the oral mucosa using sutures and flowable composite. | Device | BioMend - Jason - OSSIX, BioMend - OSSIX - Jason, Jason - BioMend - OSSIX, Jason - OSSIX - BioMend, OSSIX - BioMend - Jason, OSSIX - Jason - BioMend |
| Membrane BioMend Extend Glutaraldehyde cross-linkedThe membrane will be stabilized in the oral mucosa using sutures and flowable composite. | Device | BioMend - Jason - OSSIX, BioMend - OSSIX - Jason, Jason - BioMend - OSSIX, Jason - OSSIX - BioMend, OSSIX - BioMend - Jason, OSSIX - Jason - BioMend |
| Membrane OSSIX Agile Ribose cross-linked (RCL)The membrane will be stabilized in the oral mucosa using sutures and flowable composite. | Device | BioMend - Jason - OSSIX, BioMend - OSSIX - Jason, Jason - BioMend - OSSIX, Jason - OSSIX - BioMend, OSSIX - BioMend - Jason, OSSIX - Jason - BioMend |
Primary outcome
Degradation rates of three different collagen membranes simulating exposure to the oral environment.
Time frame: 10 days
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.
1 secondary outcome
Degradation rates of three different collagen membranes simulating exposure to the oral environment.
Time frame: 3 and 7 days
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 6 Aug 2026.
- Background: PubMed 20666799Klinger 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.
- Individual participant dataSharing planned: No
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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.
Andrea Ravida, DDS, MS, PhD principal investigator
Program Director of the Periodontics and Implant Dentistry Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Membrane Jason MB GmbH Non-cross-linked (NCL), Membrane BioMend Extend Glutaraldehyde cross-linked and Membrane OSSIX Agile Ribose cross-linked (RCL) in people with Bone Regeneration, run by Andrea Ravida at 1 site in United States.
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 3 inclusion and 4 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 6 Aug 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 United States. 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?
Degradation rates of three different collagen membranes simulating exposure to the oral environment. (time frame: 10 days). 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 NCT06944639, which also lists 1 linked publication.
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 6 Aug 2026.