Effects of Doxycycline slow release adjunctive to mechanical nonsurgical therapy.
Objectives: -to evaluate the therapeutic effects of biodegradable doxycycline slow release (14%) gel (DSRG) adjunctively administered to non-surgical therapy in a multi-center, randomized controlled, parallel group trial after three months. (Interim analysis) Material & Methods: In 5 clinical centers, randomization assigned 61 test and 58 control patients with moderate to severe recurrent periodontitis to mechanical ultrasonic/sonic instrumentation with (T) and without (C) subsequent administration of a 14% DSRG into residual periodontal pockets of at least 5mm depth and bleeding on probing (BOP). Therapeutic effects were evaluated on a short term basis (3 months) as changes of pocket probing depth (PPD), in BOP, treatment time, probing attachment levels and need for re-treatment. Safety and tolerability parameters were evaluated as well. An interim analysis of the data was performed after 3 months with a planned continuation of the study for 6 and 12 months after intervention. Results: At baseline, the two groups were comparable with regards to demographic data and mean PPD. The DSRG treated patients showed a significantly higher decrease in PPD than the control group (.0.79mm vs. 0.65mm, p=0.0013). In absolute values, PPD decreased from 4.67mm to 3.89mm in the test and from 4.74mm to 4.1mm in the control group, respectively. A multilevel analysis showed that 90% of the variance were due to the treatment effect, while 5% of the variance were due to center and patient effects. 9 minor adverse effects, not related to the trial medication were reported. Conclusion: Beneficial clinical effects (reduction in PPD) were documented for DSRG application adjunctive to mechanical debridement for residual pockets in periodontal maintenance patients. DSRG can be considered safe and well tolerated.
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