Currently Enrolling Trials
Atridox (doxycycline hyclate) 10% is a broad-spectrum semisynthetic tetracycline.Doxycycline is bacteriostatic, inhibiting bacterial protein synthesis due to disruption of transfer RNA and messenger RNA at ribosomal sites.
Atridox is specifically indicated for use in the treatment of chronic adult periodontitis for a gain in clinical attachment, reduction in probing depth, and reduction in bleeding on probing.
The Atridox product is a subgingival controlled-release product composed of a two syringe mixing system. Atridox is a variable dose product dependent on the size, shape, and number of pockets being treated.
Mechanism of Action
Doxycycline is a broad-spectrum semisynthetic tetracycyline. Doxycycline is bacteriostatic, inhibiting bacterial protein synthesis due to disruption of transfer RNA and messenger RNA at ribosomal sites.
In vitro testing has shown that Porphyromonas gingivalis, Prevotella intermedia, Campylobacter rectus, and Fusobacterium nucleatum, which are associated with periodontal disease, are susceptible to doxycycline at concentrations <6.0 µg/mL.
Atridox should not be used in patients who are hypersensitive to doxycycline or any other drug in the tetracycline class.
Adverse effects associated with the use of Atridox may include, but are not limited to, the following:
- Gum discomfort, pain or soreness; loss of attachment; increased pocket depth
- Toothache, pressure sensitivity
- Periodontal abscess, exudate, infection, drainage, extreme mobility, suppuration
- Thermal tooth sensitivity
- Gum inflammation, swelling, sensitivity
- Soft tissue erythema, sore mouth, unspecified pain
- Indigestion, upset stomach, diarrhea
Clinical Trial Results
The FDA approval of Atridox was based on two well-controlled, multicenter, parallel-design, nine-month clinical trials. A total of 831 patients (Study 1=411; Study 2=420) with chronic adult periodontitis characterized by a mean probing depth of 5.9 to 6.0 mm were enrolled. Subjects received one of four treatments: Atridox, scaling and root planing, vehicle control and oral hygiene. Treatment was administered to sites with probing depths 5 mm or greater that bled on probing. Subjects with detectable subgingival calculus on greater than 80% of all tooth surfaces were excluded from enrollment. All subjects received a second administration of the initially randomized treatment four months after their baseline treatment. Changes in the efficacy parameters, attachment level, pocket depth, and bleeding on probing, between baseline and month 9 showed that:
- Atridox was superior to Vehicle Control and Oral Hygiene
- Atridox met the decision rule of being at least 75% as good as Scaling and Root Planing (SRP) (the standard of at least 75% as good as SRP is required for any product approved as a stand alone therapy for periodontitis).
In addition, a single-center, single-blind, randomized, clinical study in 45 subjects with periodontal disease demonstrated that a single treatment with Atridox resulted in the reduction in the numbers of P. gingivalis, P. intermedia, C. rectus, F. nucleatum, Bacteroides forsythus, and E. corrodens in subgingival plaque samples. Levels of aerobic and anaerobic bacteria were also reduced after treatment with Atridox. During these studies, no overgrowth of opportunistic organisms such as Gram-negative bacilli and yeast were observed. However, as with other antibiotic preparations, Atridox therapy may result in the overgrowth of non-susceptible organisms including fungi.