Subject: Local Delivery of Antimicrobial Agents (LDAs) via a Controlled-Release Vehicle Into Diseased Crevicular Tissue, Per Tooth, by Report. Use of Controlled Release of Antimicrobial Agents as Adjunctive Therapy in the Treatment of Adult Periodontitis
Reviewed: May 21, 2012
Important NoteThis Clinical Policy Bulletin expresses our determination of whether certain services or supplies are medically necessary. We have reached these conclusions based on a review of currently available clinical information including:
The use of antimicrobial agents will be considered for coverage in localized recurrent and/or residual pockets with inflammation identified following the completion and clinical reevaluation of scaling and root planing (SRP). Our policy requires a minimum 4 weeks for adequate response to root planing and scaling prior to reevaluation. Treatment with antimicrobial agents is considered a dental procedure and subject to applicable dental plan provisions.
We will determine necessity and appropriateness through review of corresponding diagnostics and a rationale if necessary. Need for local antimicrobial agents will be determined based upon the number of teeth treated versus the need for alternate periodontal therapy (for example, periodontal surgery). A single application will be considered on the same tooth/teeth in a 12-month period on a per-tooth basis regardless of how many “sites” (for example, buccal and lingual pockets) per tooth are treated.
If there are multiple sites of recurrent and/or residual pockets with inflammation subsequent to completion of periodontal scaling and root planing, other more extensive periodontal treatment modalities (for example, surgery) may be more appropriate therapy.
The placement of antimicrobial agents into diseased periodontal pockets for extended time periods is acceptable clinical practice in a select group of patients.
At present, four antimicrobial agents/delivery systems --Actisite®, Atridox®, Arestin® and PerioChip® -- have been shown to be clinically safe and efficacious. These systems are used as injectables (Atridox); fibers (Actisite); microspheres using a syringe delivery system for sulcular placement (Arestin); and chips (PerioChip). The active agents in each product are antimicrobials and are effective against a broad spectrum of crevicular microbial flora.
Actisite, 25 percent tetracycline hydrochloride impregnated into an ethylene/vinyl acetate copolymer elastic fiber, has been used in clinical practice for over 5 years. Atridox, 10 percent doxycycline hyclate, was approved by the FDA for clinical use in September 1998. PerioChip, 2.5 mg of chlorhexidine gluconate in a hydrolyzed gelatin base, was approved by the FDA for clinical use in May 1998. Arestin, 1 mg minocycline HCl microspheres, was approved by the FDA for clinical use in May 2001. Actisite fibers must be removed from the pocket(s) at a second visit because the fibers are not biodegradable. The other three agents are biodegradable over a 7- to 10-day period of useful life.
Adult periodontitis is routinely treated with plaque control, periodontal SRP and, as required, various surgical procedures. Active periodontal therapy is followed by supportive periodontal therapy, approximately 3 to 4 months after active treatment.
At this time, all four listed products are indicated for treatment in active and recurrent and/or residual pockets with inflammation. An active site is usually described as a periodontal pocket, 5 millimeters or greater, that shows clinical signs of inflammation, bleeding, suppuration, increasing pocket depth and/or increasing attachment loss. If there are multiple sites of recurrent and/or residual inflammation after periodontal scaling and root planing has been completed, more extensive periodontal therapeutic modalities (for example, surgery) may need to be appropriately employed. The use of subgingivally placed chemotherapeutic agents may also be indicated as an adjunct to periodontal maintenance therapy when localized recurrent and/or residual sites with inflammation are found. Antimicrobial agents may also be used in the treatment of an acute periodontal abscess, when the depth of the pocket remains constant.
The use of antimicrobial agents may be indicated following the initial phase of periodontal therapy. Thorough SRP is highly effective in the treatment of chronic periodontitis and is the standard approach to non-surgical periodontal therapy. In most cases the majority of sites will respond and require no additional adjunctive or aggressive therapy.
The success of the overall periodontal treatment performed during the initial phase should be assessed in 4 to 6 weeks following treatment. If limited refractory periodontitis is confined to one or a few isolated sites, the use of these agents may be indicated. If a generalized pattern of nonresponsive periodontitis is found, a more comprehensive intervention of surgical resection and regeneration may be the appropriate treatment of choice, subject to individual clinical circumstances.
Specific to DMI program: Because additional studies are needed regarding the effectiveness of LDAs in special populations (for example, those who are medically compromised,) the use of LDAs in DMI (Dental-Medical Integration) program members may be considered for coverage concurrently with scaling and root planing.
Antimicrobial agents and implants
The use of the antimicrobial agent Arestin has not been clinically tested for use in the regeneration of alveolar bone, either in preparation for or in conjunction with the placement of endosseous dental implants or in the treatment of failing implants.6 The use of Arestin in this application is considered by Aetna to be experimental and/or still under clinical investigation, and therefore is excluded from coverage.
D4381 -- Localized delivery of antimicrobial agents via a controlled-release vehicle into diseased crevicular tissue, per tooth, by report.
FDA approved subgingival delivery devices containing antimicrobial medication(s) are inserted into periodontal pockets to suppress the pathogenic microbiota. These devices slowly release the pharmacological agent so they can remain at the intended site of action in a therapeutic concentration for a sufficient length of time.4
Aetna supports the nomenclature and descriptor as stated in the Current Dental Terminology (CDT), Code on Dental Procedures and Nomenclature as published by the American Dental Association.4 As the code specifically references a per-tooth application, and does not reference a tray-delivery method (such as the Perio Protect® system), nor the adjunctive use of a specialized technology (such as the utilization of lasers), benefits for delivery techniques, methods and/or specialized technology will not be considered for other than the service as defined by the CDT code (please see above).
Revision DatesOriginal policy: November 23, 2004
The above policy is based on the following references:1 Paquette, David W. Minocycline microspheres: a complementary medical-mechanical model for the treatment of chronic periodontitis. Compendium. May 2002; Volume 23: No. 5 (Suppl):3.
* Copyright 2010 American Dental Association. All rights reserved.
Property of Aetna. All rights reserved. Dental Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical/dental advice. This Dental Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating health care professionals are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating health care professionals are solely responsible for medical/dental advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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