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NCT Number: NCT06944639

Comparative Study of Three Collagen Membranes: 1 Non-cross-linked and 2 Cross-linked

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Bone Regeneration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh, School of Dental Medicine

Pittsburgh, Pennsylvania, 15213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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-linked

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Degradation rates of three different collagen membranes simulating exposure to the oral environment.

    Time frame: 3 and 7 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.

Sponsors and collaborators

Lead sponsor

Andrea Ravida

Other

Collaborators

  • Dentsply Sirona Inc.

Registry information

Official study title

Comparative Analysis of Three Types of Collagen Membranes Exposed to the Oral Environment: a Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2025
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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