The evidence behind DermaBind CH.
Every claim DermaBind CH makes is traceable to published, peer-reviewed data or verifiable regulatory documentation. This section sets out the science, the structure, and the clinical applications of the product in periodontal and oral surgical practice.
The evidence behind DermaBind CH.
Every claim DermaBind CH makes is traceable to published, peer-reviewed data or verifiable regulatory documentation. This section sets out the science, the structure, and the clinical applications of the product in periodontal and oral surgical practice.
What DermaBind CH Is
The Evidence
Section 361 – What It Means for Your Practice
Product Specifications
What DermaBind Is
The Evidence
Section 361 – What It Means for Your Practice
Product Specifications
PRODUCT OVERVIEW
A dehydrated natural chorion membrane, preserved in full.
A dehydrated natural chorion membrane, preserved in full.
DermaBind CH is processed through a proprietary method that retains the native extracellular matrix of the chorion, the outer placental membrane. The collagen-rich scaffold is preserved intact, with Types I, III, IV, V, and VI collagen retained alongside the structural proteins that give the membrane its biological architecture.
No chemicals, antibiotics, or preservatives are introduced during processing. The result is a wound covering whose composition reflects the tissue as it existed before processing.
What chorion is
The human placenta is composed of two membranes: the amnion, which is in contact with the fetus, and the outer chorionic membrane. Chorion is approximately 300 µm thick, four to five times the thickness of amnion. This structural density has direct clinical consequences. The membrane handles with stability, conforms to irregular defect geometry, and self-adheres without suturing in most cases.
How it is applied
Open sterile packaging using aseptic technique. Place directly on the treatment site. DermaBind CH conforms naturally and self-hydrates with blood during the procedure. No trimming, pre-hydration, or orientation is required. Suturing is optional. The membrane may be layered with other membranes or materials as the clinical situation requires. It resorbs fully over time — no second surgical procedure is needed for removal.
Section 361 HCT/P
FDA Tissue Reference Group Confirmed
PEER-REVIEWED CLINICAL DATA
Published across 21 studies. 375 patients.
Seven clinical applications.
Published across 21 studies. 375 patients.
Seven clinical applications.
The clinical evidence for chorion membranes in oral and periodontal surgery is drawn from a peer-reviewed systematic review published in the Journal of Biomedical Materials Research (Gulameabasse et al., 2020). The review was conducted according to PRISMA reporting standards and registered in the PROSPERO database. It identified 21 eligible studies, the majority of which were randomized clinical trials.
EVIDENCE SUMMARY BY APPLICATION
Gingival recession treatment.
Seven studies evaluated chorion for root coverage using coronally advanced flap technique. Across five randomized controlled trials, chorion showed equal or better outcomes compared to amnion and platelet-rich fibrin membranes for keratinized tissue width, gingival thickness, recession width, and root coverage percentage. Gingival biotype conversion to thick was observed in multiple studies.
Periodontal intrabony and furcation defects.
Six studies examined chorion in periodontal pocket therapy. Three randomized controlled trials demonstrated significantly better outcomes for chorion versus open flap debridement alone, across probing depth, clinical attachment level, and bone gain at 12 months. Biochemical analysis showed significantly increased IL-11 levels at chorion sites, consistent with reduced post-operative inflammation.
Alveolar ridge preservation.
Chorion and amnion/chorion membranes showed comparable ridge volume outcomes to dense PTFE membranes at 22-month follow-up in a randomized controlled trial. Histomorphometric analysis at the same sites demonstrated better bone quality, higher osteoid volume, and a faster bone turnover rate at chorion sites, with significantly lower pain scores at 24 and 48 hours post-operatively
Keratinized tissue augmentation around implants.
Case series data support chorion for keratinized tissue width increase around dental implants, with an average gain of 2 mm in keratinized gingival width across sites treated at implant placement or second-stage reopening.
Additional applications.
Studies also report use in Schneiderian membrane repair during sinus elevation and coverage of large mandibular defects following segmental resection, with satisfactory outcomes and no membrane-related complications in any included study.
Safety profile.
No rejection reactions were reported across any of the 375 patients in the reviewed literature. Chorion does not express HLA class I or II antigens. No post-operative inflammatory or infectious complications attributable to the membrane were observed.
Source: Gulameabasse S, Gindraux F, Catros S, Fricain J-C, Fenelon M. Chorion and amnion/chorion membranes in oral and periodontal surgery: A systematic review. J Biomed Mater Res. 2020. DOI: 10.1002/jbm.b.34783
Source: Gulameabasse S, Gindraux F, Catros S, Fricain J-C, Fenelon M. Chorion and amnion/chorion membranes in oral and periodontal surgery: A systematic review. J Biomed Mater Res. 2020. DOI: 10.1002/jbm.b.34783
Section 361 HCT/P: What it is, and why it matters.
Section 361 HCT/P: What it is, and why it matters.
DermaBind CH is regulated as a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) under Section 361 of the Public Health Service Act and 21 CFR Part 1271. The FDA Tissue Reference Group confirmed this classification for DermaBind CH when intended for use as a wound covering for acute and chronic wounds (December 22, 2022).
DermaBind CH is regulated as a Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) under Section 361 of the Public Health Service Act and 21 CFR Part 1271. The FDA Tissue Reference Group confirmed this classification for DermaBind CH when intended for use as a wound covering for acute and chronic wounds (December 22, 2022).
Section 361 classification means the product meets all four criteria set out in 21 CFR § 1271.10(a): it is minimally manipulated, intended for homologous use, not combined with a drug or device, and does not raise systemic safety concerns. Products meeting these criteria are regulated differently from drugs and devices and are not subject to pre-market approval or clearance requirements.
Clinicians using DermaBind CH in periodontal and oral surgical procedures should apply the product consistent with its regulatory classification and their documented clinical judgment. Coding is procedure-based under CDT guidelines and does not alter the product’s regulatory status.
Section 361 classification means the product meets all four criteria set out in 21 CFR § 1271.10(a): it is minimally manipulated, intended for homologous use, not combined with a drug or device, and does not raise systemic safety concerns. Products meeting these criteria are regulated differently from drugs and devices and are not subject to pre-market approval or clearance requirements.
Clinicians using DermaBind CH in periodontal and oral surgical procedures should apply the product consistent with its regulatory classification and their documented clinical judgment. Coding is procedure-based under CDT guidelines and does not alter the product’s regulatory status.
DermaBind CH
Technical Specifications
COMPOSITION
Natural chorion tissue. Collagen Types I, III, IV, V, VI.
PROCESSING
Proprietary method preserving extracellular matrix. No chemicals, antibiotics, or preservatives.
STERILITY
SAL 10⁻⁶ under FDA standards. Gamma irradiation.
STORAGE
Ambient temperature. Do not freeze. Five-year shelf life.
PREPARATION AT POINT OF CARE
None required. Self-hydrates in situ.
FIXATION
Suturing optional. Self-adhering in most clinical positions.
COMPATIBILITY
Implants, root surfaces, mesh, palatal tissue. Compatible with secondary dressings and regenerative measures.
SIZES
10 × 10 mm
20 × 20 mm
30 × 30 mm
MANUFACTURING
HealthTech Wound Care, Inc. ISO-certified facility, Salt Lake City, Utah.
DONOR SCREENING
Exclusively distributed by World Reach Health, LLC
Billing support: reimbursement@levarisglobal.com
Let’s look at your protocol together.
If you are evaluating DermaBind CH for periodontal or oral surgical use, we would rather start with a conversation about your clinical practice than a brochure about ours. Tell us about the procedures you are managing and the outcomes you are working toward.
If you are evaluating DermaBind CH for periodontal or oral surgical use, we would rather start with a conversation about your clinical practice than a brochure about ours. Tell us about the procedures you are managing and the outcomes you are working toward.