Statement on Periostat® as an Adjunct to Scaling and Root Planing
Periostat® is a systemically delivered collagenase inhibitor consisting of a 20-mg capsule of doxycycline hyclate for oral administration. This is the first FDA approved systemic drug for host modulation as an adjunct to scaling and root planing in the treatment of periodontitis. Periostat, administered BID, reduced the elevated collagenase activity in the gingival fluid of patients with adult periodontitis.
A randomized, multi-center, double blind study was performed to compare the efficacy of scaling and root planing (SRP) plus placebo to scaling and root planing plus Periostat administered BID. That study revealed statistically significant pocket depth reduction with adjunctive use of Periostat at 3, 6, and 9 months post initial therapy (for initial depth >7mm, 1.20 vs. 1.68 mm, at depths 4-6 mm, 0.69 vs. 0.95 mm) and gain of clinical attachment (for initial depths >7 mm, 1.17 mm vs. 1.35 mm, at depths 4-6 mm, 0.86 vs. 1.03 mm). Mean changes in pocket depth and attachment level across large numbers of patients and tooth sites were small, and may not reflect the magnitude of change that may occur in an individual patient or tooth site. For example, when SRP plus Periostat was compared with SRP plus placebo, more sites initially demonstrating 5 to 8 mm probing depth exhibited >2 mm reduction in probing depth (41% vs. 30%, 886 vs. 640 sites).
In a 3-month follow-up study, where patients received no additional therapy, pocket depth reductions and clinical attachment level gains observed following 9 months adjunctive Periostat were maintained. The Academy is not aware of any data regarding treatment outcomes for periods longer than 12 months.
At present the Academy is not aware of any available data concerning the need for surgical or non-surgical treatment of sites after using Periostat. Furthermore, there are no studies to the Academy's knowledge which address the use of Periostat in the treatment of specific types of periodontal defects or diseases other than adult periodontitis.
When considering using Periostat or other adjuncts to SRP, clinicians must consider the expected results in view of the severity of the defects being treated. Furthermore, it should be noted that adjunctive procedures to enhance conventional therapies are not a substitute for meticulous home care, professional root planing and appropriate treatment designed to minimize bacterial load and facilitate proper home care. In this regard, each practitioner must determine the usefulness of Periostat in light of the available data and needs of the individual patient.
- Caton J, Blieden T, Adams D, et al. Subantimicrobial doxycycline therapy for periodontitis. J Dent Res 1997;76:177 (Abstract # 1307).
- Caton J, Ciancio S, Crout R, Hefti A, Polson A. Adjunctive use of subantimicrobial doxycycline therapy for periodontitis. J Dent Res 1998;77:1001 (Abstract # 2957).
This statement was revised by the Committee on Research, Science and Therapy and approved by the Board of Trustees of the American Academy of Periodontology in January 2000. This statement on Periostat replaces the one approved in June 1998.