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Return to Current Clinical
Studies |
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Periodoxymer
John
Novak, PhD, MS, LDS, BDS, Principal Investigator |
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Background |
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Adult
periodontitis is characterized as a complex disease comprised
of a host interaction with pathogenic bacteria that results in
inflammation and the degradation of the periodontal attachment
apparatus and alveolar bone. Gram negative periodontal
pathogens produce endotoxins that up-regulate cytokine
production, increase inflammatory cell infiltration, and
increase the production and release of proteolytic enzymes
that are responsible for the degradation of periodontal
tissues. 1
Scaling and root planing (SRP) combined with oral hygiene
instruction are considered the normal non-surgical standard of
care for periodontal disease and frequently results in
reduction in pocket depth of 1-2mm2,3.
Doxycycline has
been routinely used as a broad spectrum bacteriostatic agent
for many years. Recent studies have shown that doxycycline may
exert an additionally benefical clinical effect on
inflammation and inflammatory pathology through its ability to
inhibit the enzyme collagenase especially in periodontal
disease4,5. Doxycycline delivered systemically at
sub-antimicrobial doses (20 mg b.i.d.; Periostat) has been
shown to inhibit pathologically elevated proteases
(specifically collagenase) in the periodontal tissues
resulting in gains in attachment and reductions in pocket
depth 4-7. At this low dose, Periostat has shown no
bacteriostatic effects on the oral, vaginal or gut microflora
with respect to changes in the constituent bacteria or in the
development of antimicrobial resistance8-10
Periostat is currently used by dentists in the US and Europe
as a twice daily administration of 20mg doxycycline hyclate as
an adjunct therapy to scaling and root planing for the
treatment of periodontal disease. The present study is to test
the efficacy of a new, once-a-day, modified release
formulation capsule containing 40mg of doxycycline monohydrate
in combination with scaling and root planing in patients with
adult periodontitis.
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| Literature cited: |
1. Page RC, Kornman KS.
The pathogenesis of human periodontitis: an introduction.
Periodontol 2000 1997;14:9-11.
2. Greenstein G. Periodontal response to mechanical
non-surgical therapy: a review.
J Periodontol 1992;63:118-130.
3. Cobb CM. Non-surgical pocket therapy: mechanical. Ann
Periodontal 1996;1:443-490.
4. Golub LM, Ciancio S, Ramamurthy NS, Leung M, McNamara TF.
Low-dose doxycycline therapy: effect on gingival and
crevicular fluid collagenase activity in humans. J
Periodont Res 1990;25:321-330.
5. Golub LM, Sorsa T, Lee HM, et al. Doxycycline inhibits
neutrophil (PMN)-type matrix metalloproteinases in human adult
periodontitis gingiva. J Clin Periodontal
1995;22:100-109.
6. Caton JG, Ciancio SG, Blieden TM, et al. Treatment with
subantimicrobial dose doxycycline improves the efficacy of
scaling and root planning in patients with adult periodontitis.
J Periodontol 2000;71:521-532.
7. Novak MJ, Johns LP, Miller RC, and Bradshaw MH. Adjunctive
benefits of subantimicrobial dose doxycycline in the
management of severe, generalized, chronic periodontitis. J
Periodontol 2002; 73:763-770.
8. Thomas J, Walker C, Bradshaw M. Long-term use of
subantimicrobial dose doxycycline does not lead to changes in
antimicrobial susceptibility. J Periodontol
2000;761:1472-1483.
9. Walker C, Thomas J, Nango S, Lennon J, Wetzel J, and Powala
C. Long term treatment with subantimicrobial dose doxycycline
exerts no antibacterial effect on the subgingival microflora
associated with adult periodontitis. J Periodontol
2000;71:1465-1471.
10. Walker C, Gollwitzer J, Nango S, Novak J, Hefti A, Preshaw
P, and Powala C. Long term treatment with subantimicrobial
dose doxycycline exerts no antibacterial effect on the
intestinal or vaginal microflora. J Periodontol (in
press). |
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