Biologic Materials for Dental Indications

Coverage Summary

Coverage stance: mixed. Scope: UnitedHealthcare Dental clinical policy DCP047.04 (effective June 1, 2025) on biologic materials for soft and osseous tissue regeneration, autologous blood concentrates, and intra-socket biological dressings.

Indicated biologics (may be indicated for regeneration): Enamel Matrix Derivative (EMD) and Bioactive Glass for intrabony defects and related periodontal regenerative uses.

Common uses stated as not indicated (insufficient evidence): use in conjunction with periradicular surgery, treatment of mucogingival deformities, and routine use of autologous blood concentrates (PRF/PRP/CGF) (collection and application not indicated).

Policy additions and limitations: the CDT code D7922 was added to the applicable codes list for placement of intra-socket biological dressing; placement of intra-socket dressings is covered only when high-risk bleeding circumstances are documented (examples: anticoagulant use, diagnosed bleeding disorders, or relevant systemic conditions) and is not routinely indicated for all extractions.

Quick facts

Effective dateJune 1, 2025

Policy numberDCP047.04

Coverage stanceMixed — specific biologics (EMD, Bioactive Glass) may be indicated; many other biologics and autologous concentrates not routinely indicated due to insufficient/heterogeneous evidence

New CDT code addedD7922 — Placement of intra-socket biological dressing to aid in hemostasis or clot stabilization

Guideline referencedAAP 2022 best evidence consensus statement

Evidence summary noteMultiple RCTs and systematic reviews/meta-analyses summarized (EMD and bioactive glass supportive for intrabony defects; autologous platelet concentrates evidence heterogeneous/low quality)

Medical Necessity / Coverage Criteria

Biologic Materials for Soft and Osseous Tissue Regeneration

Covered or indicated when specifically stated; not indicated when evidence insufficient:

May be indicated

Enamel Matrix Derivative (EMD) may be indicated to aid regeneration
Bioactive Glass may be indicated to aid regeneration

Not indicated due to insufficient evidence

Use of biological materials in conjunction with periradicular surgery is not indicated
Use of biological materials for treating mucogingival deformities is not indicated

Coding

Referenced CDT procedure codesmixed

D4265	Biologic materials to aid in soft and osseous tissue regeneration, per site
D4999	Unspecified periodontal procedure, by report
D7921	Collection and application of autologous blood concentrate product
D7922	Placement of intra-socket biological dressing to aid in hemostasis or clot stabilization, per site

Regulatory / informational code referencesmixed

21 CFR Part 1270	FDA regulation for human tissue for transplantation
21 CFR Part 1271	FDA regulation for human cells, tissues, and cellular and tissue-based products
FDA PMA P930021	Emdogain Premarket Approval reference
FDA product code LYC	bioactive glass regenerative products cleared by 510(k)
FDA product code JQC	devices for point-of-care PRP preparation
FDA K030555	GPS Platelet Separation Kit 510(k) reference

Applicable CDT codes (added)mixedCovered

D7922

Placement of intra-socket biological dressing to aid in hemostasis or clot stabilization (code added to policy)

Provider Actions & Billing Impact

Documentation Required

Document medical necessity for intra-socket dressing in bleeding-risk patients

When placing an intra-socket biological dressing for hemostasis/clot stabilization, document the high risk of uncontrolled bleeding (e.g., anticoagulant use, bleeding disorder, relevant systemic disease) to support indication; routine use for all extractions is not indicated.

D7922

Denial Risk

Autologous blood concentrates not indicated

Claims for collection and application of autologous blood concentrate products (e.g., PRF/PRP) may be denied as these are stated not indicated due to insufficient evidence of efficacy.

D7921

Background & Evidence Summary

Background: Regenerative biologic materials are used to facilitate periodontal soft- and hard-tissue regeneration but clinical efficacy varies by product and indication; definitive outcomes are confounded by use with other grafts and surgical techniques.

This policy summarizes available evidence from randomized controlled trials, systematic reviews, and meta-analyses. The evidence supports EMD (multiple SRs and RCTs showing significant improvements in intrabony defect regeneration and benefit when combined with bone grafts) and bioactive glass (2024 meta-analysis of 20 RCTs demonstrating improvement in probing depth at 6 months) for intrabony defects.

Evidence for autologous platelet concentrates (PRF/PRP/CGF) and many other biologics is heterogeneous or of low/limited quality, with variable short-term benefits but overall insufficient or inconsistent evidence to recommend routine use for many indications.

Intervention	Evidence summary
EMD	Multiple systematic reviews and RCTs demonstrate significant improvements in intrabony defect regeneration; AAP network meta-analysis and other meta-analyses recommend EMD, particularly in combination with bone grafts, and show modest benefits for root coverage when added to CAF (6–12 month outcomes).
Bioactive Glass	A 2024 meta-analysis of 20 RCTs found bioactive glass effective for probing depth (PD) improvement at 6 months but no significant impact on clinical attachment level (CAL); RCTs support its use for intrabony defects.
Autologous Platelet Concentrates (PRF/PRP/CGF)	Systematic reviews and RCTs show variable short‑term benefits for PD/CAL and radiographic bone fill in intrabony defects; overall evidence quality is low and heterogeneous. Some meta-analyses report PD and CAL improvements versus OFD, but results are inconsistent across indications. Collection/application is stated as not indicated due to insufficient evidence in policy.
Bone Morphogenic Proteins (rhBMP-2/7)	Human trials show promising osteoinductive potential and some improvements in radiographic defect fill and CAL, but evidence is limited, inconsistent, and insufficient for routine clinical use outside well‑designed clinical trials.
Amniotic Membranes (AM/CM/ACM)	Evidence is limited and heterogeneous; narrative reviews and small RCTs report promising outcomes for root coverage, barrier use, and intrabony defects, but larger long-term RCTs are lacking and safety/efficacy are not established.
rhBMP-2/7 (explicit)	Small RCTs and systematic reviews suggest potential benefit for periodontal intrabony defects (radiographic bone fill, CAL, PD reductions), but data are too limited to determine predictable, consistent clinical effectiveness.
AM/CM/ACM (grouped)	Some trials show clinical improvements in PD, CAL, and bone defect measures versus controls, but overall evidence is too limited and heterogeneous to define a clear role in periodontal regeneration.
EMD + CAF	Moderate‑certainty evidence shows improved root coverage and CAL at 6–12 months when EMD is added to a coronally advanced flap compared with CAF alone; long‑term benefit remains uncertain.
EMD (as single row already above - PRF combos)	Combination of EMD with bone grafts may result in additional CAL gain and PD reduction versus EMD alone according to meta-analyses of multiple studies.
PRF / L-PRF	Meta-analyses report improved mean root coverage (mRC), CAL, and gingival thickness when PRF is added to CAF versus CAF alone; CTG often remains superior for some outcomes. For intrabony defects, systematic reviews/meta-analyses show PD and CAL gains when PRF is adjunctive to OFD or grafts but evidence quality is variable.
Periapical Regeneration Techniques (Periapical RTs)	Systematic reviews and RCTs indicate that combination of membranes plus bone replacement analogues or bone replacement alone improve outcomes for through‑and‑through and large periapical lesions (≥10 mm); membranes alone show no significant benefit.
CGF (Concentrated Growth Factor)	A small multicenter RCT (n=24) in apical microsurgery showed no significant difference in overall success but reduced lesion volume with CGF; further research needed. Evidence is preliminary.
References updated / general evidence note	Policy summarizes multiple systematic reviews, meta-analyses, and randomized trials (2011–2025) across biologic agents informing conclusions: EMD and bioactive glass have supportive data for intrabony defects; autologous concentrates and other biologics show heterogeneous or insufficient evidence.

Definitions:

Autologous Blood Concentrates: Blood products made using the patient's own blood and include Platelet-rich fibrin (PRF) and platelet-rich plasma (PRP).

Bioactive Glass: Biocompatible bioceramic materials that chemically bond with bone and tooth tissues (dissolve in body fluids and form apatite crystals).

Biologic Materials/Biologic Response Modifiers: Agents that alter wound healing or host–tumor interaction (e.g., cytokines, growth factors) but do not include hard or soft tissue graft material.

Enamel Matrix Derivative (EMD): A porcine-derived tooth enamel matrix product.

Mucogingival Deformity: Departure from normal gingival/mucosal dimension or morphology, possibly associated with underlying alveolar bone deformity.

Revision History

06/01/2025revisedLatest

Title changed from 'Biological Materials for Soft and Hard Tissue Regeneration' to 'Biologic Materials for Dental Indications' and Coverage Rationale updated: added placement of intra-socket biological dressing to aid in hemostasis or clot stabilization for individuals with high risk of uncontrolled bleeding (examples: anticoagulant or interferon alpha use; bleeding disorders such as von Willebrand disease or hemophilia; underlying medical conditions impacting hemostasis such as immune, liver, kidney, or lymphoproliferative disorders); clarified that intra-socket dressing is not routinely indicated for all extractions.

06/01/2025addedLatest

Added CDT code D7922 to Applicable Codes: 'placement of intra-socket biological dressing to aid in hemostasis or clot stabilization, per site'.

Clinical evidence-based conclusions and applicability

Summarized conclusions from multiple systematic reviews, RCTs and guideline statements regarding use of biologic materials in dental procedures:

ALL of the following

Bone morphogenetic proteins (rhBMP-2 and rhBMP-7): promising osteoinductive potential in periodontal regeneration but evidence insufficient and inconsistent for routine clinical use outside well-designed clinical trials
Amniotic/chorion membranes (AM/CM/ACM): limited and heterogeneous evidence; some trials show promising outcomes for root coverage, barrier use, and pocket/attachment improvements but larger, long-term RCTs are lacking to determine efficacy for periodontal regeneration and bone regeneration
Mesenchymal stem cells (MSCs): low-quality evidence from small RCTs suggests small CAL improvement at 3 months; insufficient evidence to recommend clinical use
Xenogeneic collagen matrix (CMX): meta-analysis shows lower root coverage outcomes vs connective tissue graft (CTG); not as effective as CTG for multiple adjacent recessions
Acellular dermal matrix grafts (ADMG) and enamel matrix protein (EMP): insufficient evidence to show superiority vs CTG; CTG shows slight improvement for root coverage and keratinized tissue width
Enamel matrix derivative (EMD): meta-analyses show modest benefits for root coverage and CAL when added to CAF or CAF+CTG in Miller Class I/II recessions (6-12 month outcomes); uncertain long-term benefit
Platelet-rich fibrin (PRF) / leukocyte-PRF (L-PRF): evidence suggests PRF adjunct to CAF may improve root coverage, CAL and gingival thickness vs CAF alone; CTG remains gold standard for many indications
Periradicular surgery: regeneration techniques (membranes + bone replacement analogues or bone replacement alone) show benefit for through-and-through and large lesions (≥10 mm); membranes alone not beneficial
Concentrated growth factor (CGF): single small RCT (n=24) showed no significant difference in success but reduced lesion volume; further study needed
Clinical Practice Guideline (AAP 2022 best evidence consensus): SCTG remains gold standard for root coverage; biologics can enhance initial postoperative healing; biologics effective for infrabony defects, with rhPDGF-BB and PRF associated with superior outcomes compared to EMD and PRP; limited evidence for ARP/ARR/ISD