Microbiology

The clinical significance of the microbiological findings with Actisite is not known. The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by inhibiting protein synthesis. In vitro testing has shown that probable periodontal pathogens, including Fusobacterium nucleatum, Porphyromonas (Bacteroides) gingivalis, Prevotella intermedia (Bacteroides intermedius), Eikenella corrodens, Campylobacter rectus (Wolinella recta), and Actinobacillus actinomycetemcomitans, are susceptible to local 32 µg/mL tetracycline concentrations achieved in the periodontal pocket with the use of Actisite® (tetracycline hydrochloride) periodontal fiber.

Pharmacokinetics

Actisite fiber releases tetracycline in vitro at a rate of approximately 2 µg/cm-h. In the periodontal pocket, the system provides for a per site mean gingival fluid concentration of 1590 µg/mL tetracycline throughout the 10-day treatment period.

Concentration in saliva immediately after fiber placement (9 teeth) was 50.7 µg/mL and declined to 7.6 µg/mL at the end of 10 days.

During fiber treatment of up to 11 teeth per patient (average tetracycline dose of 105 mg) mean tetracycline concentrations in plasma were below the lower limit of assay detection (<0.1 µg/mL). This lower assay limit is 20- to 25-fold lower than that expected during a regimen of 250 mg by oral capsule every 6 hours.

Clinical Studies

In a controlled 60-day clinical trial, 113 adult patients with periodontitis (56 men and 57 women; age range 25-88; 95 Caucasian, 11 Black, 3 Hispanic and 4 Asian) entered with a mean pocket depth of 7.2 mm (98% of pocket depths were within the range of 4 mm to 11 mm). Subjects received supragingival cleaning followed by one of four treatments, randomized to a single tooth per quadrant. These treatments were: 1) Actisite fiber for 10 ± 2 days, 2) control fiber for 10 ± 2 days, 3) scaling and root planing under local anesthesia, or 4) no treatment. Teeth treated with Actisite fiber were later found to have significantly reduced probing depth and bleeding on controlled force probing. Probing depth reductions were greater in deep (> or equal to 7 mm) than in moderate (< or equal to 6 mm) sites.

In a randomized, single-blind 6-month study of 113 adult periodontal maintenance patients (57 men and 56 women; age range 32-75; 111 Caucasian, 2 Black), the effects of scaling and root planing alone, and scaling and root planing followed by Actisite fiber treatment, were compared. Subjects entered with a baseline pocket depth mean of 6.4mm (97% of the pockets were within a range of 4 mm to 11 mm). Two non-adjacent sites with pockets with bleeding on probing were selected for treatment and follow-up at 1, 3, and 6 months. A longitudinal multi-variate analysis showed that adjunctive fiber therapy with scaling and root planing provided significantly greater reductions in probing depth and bleeding on probing than scaling and root planing alone at follow-up visits. The results are summarized in the following table:

* Significant difference between treatment groups (p<0.05)
** Significant difference between treatment groups (p<0.01)
^aS/RP = scaling and root planing

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