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Actisite (tetracycline periodontal) fiber has been studied in 1437 patients distributed as follows over pivotal, controlled, and open- label studies.

  Study Type
Demographics Pivotal Controlled Uncontrolled TOTAL
Gender:        
Male 113 70 455 638
Female 113 55 631 799
Age Range 25-88 25-73 13-87 13-88
Race:        
Black 13 12 41 66
Asian 4 1 10 15
Hispanic 3 3 11 17
Caucasian 206 105 964 1275
Native American 0 2 56 58
Other 0 2 5 7

The most frequently reported adverse reactions in the 226 patients in the pivotal clinical trials were discomfort on fiber placement (10%) and local erythema following removal (11%).

In controlled and open-label trials patients, the following adverse reactions have been reported in less than 1% of patients: oral candidiasis, glossitis, possible allergic response, staining of the tongue, severe gingival inflammation, throbbing pain, pain following placement in an abscessed area, and minor throat irritation.