Gingival fluid tetracycline release from bioerodible gels

Area of Science:

• Periodontology
• Drug Delivery Systems
• Antimicrobial Therapy

Background:

• Periodontitis requires site-specific antimicrobial therapy.
• Non-resorbable fibers have been used, but bioerodible systems are preferred.
• Tetracycline hydrochloride is a potential antimicrobial agent for periodontal pockets.

Purpose of the Study:

• To assess the drug release and safety of a novel syringable 35% tetracycline hydrochloride in a lactic-glycolic acid bioerodible gel.
• To evaluate the antimicrobial efficacy of the gel based on drug concentrations in gingival crevicular fluid (GCF).

Main Methods:

• A randomized, double-blind, eight-day study involving 31 healthy adult volunteers.
• Application of small and large particle size tetracycline hydrochloride gels into periodontal pockets.
• Collection and analysis of GCF for tetracycline concentration and volume at multiple time points post-treatment.

Main Results:

• High tetracycline concentrations (>100 µg/ml) were found at 3 days in 61% (large particles) and 71% (small particles) of sites.
• Measurable tetracycline was present at 8 days in 37% (large particles) and 55% (small particles) of sites.
• The most common adverse event was a bitter taste; no serious adverse events were reported.

Conclusions:

• The bioerodible tetracycline hydrochloride gels demonstrated safety and favorable drug release profiles.
• Achieved GCF tetracycline levels suggest significant antimicrobial efficacy against periodontopathogens.
• These gels represent a promising advancement in localized periodontal antimicrobial therapy.