ClinicalTrials.Veeva

Menu

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

A

Andrea Ravida

Status

Not yet enrolling

Conditions

Bone Regeneration

Treatments

Device: Membrane Jason MB GmbH Non-cross-linked (NCL)
Device: Membrane BioMend Extend Glutaraldehyde cross-linked
Device: Membrane OSSIX Agile Ribose cross-linked (RCL)

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06944639
STUDY24100119

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 6 patient groups

OSSIX - BioMend - Jason
Active Comparator group
Description:
Possible unique ordering of the 3 different membranes to which participants may be randomized
Treatment:
Device: Membrane OSSIX Agile Ribose cross-linked (RCL)
Device: Membrane BioMend Extend Glutaraldehyde cross-linked
Device: Membrane Jason MB GmbH Non-cross-linked (NCL)
BioMend - OSSIX - Jason
Active Comparator group
Description:
Possible unique ordering of the 3 different membranes to which participants may be randomized
Treatment:
Device: Membrane OSSIX Agile Ribose cross-linked (RCL)
Device: Membrane BioMend Extend Glutaraldehyde cross-linked
Device: Membrane Jason MB GmbH Non-cross-linked (NCL)
BioMend - Jason - OSSIX
Active Comparator group
Description:
Possible unique ordering of the 3 different membranes to which participants may be randomized
Treatment:
Device: Membrane OSSIX Agile Ribose cross-linked (RCL)
Device: Membrane BioMend Extend Glutaraldehyde cross-linked
Device: Membrane Jason MB GmbH Non-cross-linked (NCL)
Jason - OSSIX - BioMend
Active Comparator group
Description:
Possible unique ordering of the 3 different membranes to which participants may be randomized
Treatment:
Device: Membrane OSSIX Agile Ribose cross-linked (RCL)
Device: Membrane BioMend Extend Glutaraldehyde cross-linked
Device: Membrane Jason MB GmbH Non-cross-linked (NCL)
Jason - BioMend - OSSIX
Active Comparator group
Description:
Possible unique ordering of the 3 different membranes to which participants may be randomized
Treatment:
Device: Membrane OSSIX Agile Ribose cross-linked (RCL)
Device: Membrane BioMend Extend Glutaraldehyde cross-linked
Device: Membrane Jason MB GmbH Non-cross-linked (NCL)
OSSIX - Jason - BioMend
Active Comparator group
Description:
Possible unique ordering of the 3 different membranes to which participants may be randomized
Treatment:
Device: Membrane OSSIX Agile Ribose cross-linked (RCL)
Device: Membrane BioMend Extend Glutaraldehyde cross-linked
Device: Membrane Jason MB GmbH Non-cross-linked (NCL)

Trial contacts and locations

1

Loading...

Central trial contact

Andrea Ravida, DDS, MS, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems