I. Disclaimer

This document is intended to be used as a reference for VA and non-VA providers. It is not intended to replace clinical judgment when determining care pathways. These guidelines do not guarantee benefits or constitute medical advice. 

Eligibility for VA dental care is defined by statute and is to be provided in accordance with the provisions of existing law and VA regulations, specifically 38 U.S.C. §§1710(c) and 1712, and 38 CFR §§17.160 through 17.166. 

II. Dental Clinical Determinations and Indications

1. Indications for Use of Biologic Materials in Periodontal Bone Grafting  
   Use of biologic materials in conjunction with appropriate periodontal bone graft scaffolds (e.g., growth factors, bone morphogenetic proteins, platelet rich plasma, enamel matrix derivative (EMD) etc.) may be considered clinically necessary when ANY of the following criteria are met: 
   • Periodontal intrabony defects: Treatment of 1-, 2-, or 3-wall intrabony defects to regenerate periodontal ligament, cementum, and alveolar bone, confirmed by radiographic evidence of bone loss 
   • Large or non-contained bone defects: Highly complex, non-contained or very large bony defects not amenable to conventional bone grafting alone 
   • Complex peri-implant and extraction-site ridge defects: Peri-implant defects which cannot be predictably treated with other grafting approaches. Severe alveolar ridge preservation or augmentation at the time of tooth extraction for planned future implant placement 
   • Favorable defect morphology: Evidence of favorable defect morphology 

2. Limitations/Exclusions
   Use of biologic materials in periodontal bone grafting is not indicated and therefore considered not clinically necessary when any of the following are applicable: 
   • Extractions: Routine extraction sockets without regenerative defects or documented need for augmentation
   • Cosmetic-only indications: Restorations performed solely for aesthetic enhancement without documented functional necessity
   • Uncontrolled periodontal disease: Presence of severe periodontal disease without documented successful periodontal therapy
   • Non-compliance: Documented inability or willingness to adhere to prior periodontal therapies
   • Allergies or hypersensitivity: Patients with allergies or known hypersensitivity to biologic components (e.g., bovine collagen in EMD)
   • rhBMP-2 use restrictions: Use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in areas with increased risk of swelling or obstruction (e.g., near airway structures)
   • Unfavorable defect morphology: Sites with inadequate bone anatomy that do not support biologic retention or regenerative potential
   • Uncontrolled systemic conditions: Conditions that impair wound healing, including but not limited to uncontrolled diabetes, autoimmune disorders, chronic corticosteroid use, hematologic conditions or immunosuppressive medication use
   • Active tobacco use: Current smoking or tobacco use, which reduces regenerative outcomes

For all other conditions or indications not listed in section II.a. of this document, biologic materials in periodontal bone grafting is considered not clinically necessary due to insufficient evidence of efficacy and safety.

3. Description of Treatment
   The use of biologic materials in periodontal bone grafting involves adding special substances to help rebuild bone and gum tissue around teeth or in preparation for dental implants. The procedure typically is done using local anesthesia or in some cases, general anesthesia or intravenous (IV) sedation for more complex treatments. The surgeon places a bone graft material (like donor bone, animal-derived bone, or synthetic material) into the area of bone loss, then adds biologic materials, such as platelet-rich fibrin (PRF, made from the patient’s own blood), enamel matrix derivatives (EMD, a protein-based gel), or growth factors (like rhPDGF-BB or rhBMP-2). These biologics boost the body’s ability to grow new bone and tissue, working with the graft to create a strong foundation. This treatment is used to repair bone damaged by gum disease, maintain jawbone shape after tooth removal, or support implants, helping the patient achieve better oral health and function.

III. Background and Supporting Information

The following information is for reference purposes only in accordance with dental eligibility as defined by statute (law). Each subsection supports VA’s determinations for clinical necessity and alignment with generally accepted standards of dental practice.

1. Background Information
   Biologic materials, such as platelet-rich fibrin (PRF), enamel matrix derivatives (EMD), and recombinant growth factors (e.g., rhPDGF-BB, rhBMP-2), are advanced adjunctive therapies in periodontal and implant dentistry. The ability of these materials to enhance the regeneration of the periodontal ligament, cementum, and alveolar bone by stimulating cellular activity, promoting blood vessel growth, and improving tissue integration must be carefully evaluated before use in each case. Their use must align with evidence-based, patient-specific treatment planning to improve oral health and quality of life.

2. Research, Clinical Trials, and Evidence Summaries
   The efficacy and safety of biologic materials in periodontal bone grafting are supported by robust clinical literature. Avila-Ortiz et al. (2022) in the Journal of Periodontology American Academy of Periodontology Best Evidence Consensus highlight significant clinical benefits, including enhanced early wound healing, improved clinical attachment levels (CAL), and reduced postoperative complications when biologics are used with grafts. Cieplik et al. (2018) in Journal of Clinical Periodontology report sustained CAL gains in intrabony defects treated with autologous platelet concentrates and guided tissue regeneration (GTR) over 13 years. Dhiman et al. (2015) in Journal of Endodontics demonstrate improved probing depth and periapical healing in apicomarginal defects with PRF. Ravi et al. (2017) in Journal of Periodontology show that plasma rich in growth factors (PRGF) with GTR significantly enhances CAL and radiographic bone fill compared to GTR alone. Estrin et al. (2022) in Oral Health & Preventive Dentistry confirm EMD’s effectiveness in minimally invasive flapless approaches for intrabony defects. Garg et al. (2023) in Cureus report significant bone regeneration in intrabony defects using rhBMP-2. These studies, combining systematic reviews, randomized controlled trials, and meta-analyses, validate the indications for biologic materials in complex periodontics.

3. U.S. Food & Drug Administration Information
   VA generally only approves use of medical devices that have received at least Food & Drug Administration (FDA) clearance for 510(k) Premarket Notification. The FDA has determined these Class II devices are substantially equivalent (SE) to legally marketed predicate devices, in terms of safety and effectiveness, and may be marketed in the U.S. Manufacturers must adhere to FDA regulations on labeling, manufacturing practices, and post-market surveillance. The FDA monitors adverse event reports and can mandate recalls. Manufacturer’s Instructions for Use (MIFU) must be followed.

   Grafting scaffolds (e.g., xenografts, allografts, synthetic materials) are typically Class II medical devices, requiring 510(k) premarket notification. Materials must comply with FDA standards for biocompatibility, safety, and efficacy under functional loads, per ISO-10993 standards.

   To search for devices that have received FDA 510(k) clearance or Premarket Approval (PMA), please visit the FDA Devices database.

4. American Dental Association Current Dental Terminology Coding Information
   The following CDT codes listed in this section are provided for informational purposes only. Inclusion or exclusion of a code does not constitute or imply VA coverage or provider reimbursement. The list of codes may not be all-inclusive since the American Dental Association (ADA) code updates may occur more frequently than dental CDI updates. Please refer to section II.a. in this document to review indications and clinical criteria for clinical necessity.

5. CPT Code	Description
   D4263	Bone replacement graft – retained natural tooth – first site in quadrant
   D4264	Bone replacement graft – retained natural tooth – each additional site in quadrant
   D4265	Biologic materials to aid in soft and osseous tissue regeneration, per site
   D6104	Bone graft at time of implant placement
   D7950	Osseous, osteoperiosteal, or cartilage graft of the mandible or maxilla – autogenous or nonautogenous, by report
   D7953	Bone replacement graft for ridge preservation – per site

6. Current Dental Terminology (CDT), Copyright © 2026 American Dental Association. All rights reserved.

IV. Definitions

Term	Definition
Biologic materials	Substances like platelet-rich fibrin, enamel matrix derivatives, and recombinant growth factors (e.g., rhPDGF-BB, rhBMP-2) used to enhance periodontal tissue regeneration
Enamel matrix derivatives	Protein-based materials that stimulate periodontal ligament and bone regeneration, typically derived from porcine enamel
Graft scaffold	Bone graft materials (e.g., xenografts, allografts, synthetic) that provide a structural framework for new bone growth, often used with biologics
Platelet-rich fibrin	An autologous material derived from the patient’s blood, rich in platelets and growth factors, used to promote tissue healing and regeneration
Recombinant growth factors	Synthetic proteins like rhPDGF-BB or rhBMP-2 that promote cell growth and bone formation in regenerative procedures

V. References

Avila-Ortiz, G., Ambruster, J., Barootchi, S., Chambrone, L., Chen, C. Y., Dixon, D. R., Geisinger, M. L., Giannobile, W. V., Goss, K., Gunsolley, J. C., Heard, R. H., Kim, D. M., Mandelaris, G. A., Monje, A., Nevins, M. L., Palaiologou-Gallis, A., Rosen, P. S., Scheyer, E. T., Suarez-Lopez Del Amo, F., Tavelli, L., … Mealey, B. L. (2022). American Academy of Periodontology best evidence consensus statement on the use of biologics in clinical practice. Journal of periodontology, 93(12), 1763–1770.

Cieplik, F., Tabenski, L., Hiller, K. A., Schmalz, G., Buchalla, W., & Christgau, M. (2018). Influence of autogenous platelet concentrate on combined GTR/graft therapy in intra-bony defects: A 13-year follow-up of a randomized controlled clinical split-mouth study. Journal of clinical periodontology, 45(3), 382–391.

Dhiman, M., Duhan, J., Singh, G. (2015). Effect of platelet-rich fibrin on healing of apicomarginal defects: A randomized controlled trial. Journal of Endodontics, 41(7), 985–991.

Estrin, N. E., Moraschini, V., Zhang, Y., & Miron, R. J. (2022). Use of Enamel Matrix Derivative in Minimally Invasive/Flapless Approaches: A Systematic Review with Meta-Analysis. Oral health & preventive dentistry, 20, 233–242.

Garg, S., Kapoor, R., Tyagi, P., et al. (2023). Treatment of human intraosseous periodontal defects using recombinant human bone morphogenetic protein-2: A randomized controlled clinical trial. Cureus, 15(6), e40395.

Ravi, S., Malaiappan, S., Varghese, S., Jayakumar, N. D., & Prakasam, G. (2017). Additive Effect of Plasma Rich in Growth Factors With Guided Tissue Regeneration in Treatment of Intrabony Defects in Patients With Chronic Periodontitis: A Split-Mouth Randomized Controlled Clinical Trial. Journal of periodontology, 88(9), 839–845.   U.S. Food and Drug Administration. (2005). Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.

U.S. Food and Drug Administration. (2005). Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices. 

VI. CDI History/Revision Information

Date	Summary of Updates
08/01/2026	New dental CDI created describing clinically necessary indications / not clinically necessary indications

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