Subgingival Minocycline Hydrochloride Ointment in Moderate to Severe Chronic Adult Periodontitis: A Randomized, Double‐Blind, Vehicle‐Controlled, Multicenter Study

Abstract

T he safety and efficacy of subgingivally‐applied 2% minocycline ointment was evaluated in a randomized, double‐blind study of 103 adults with moderate to severe periodontitis. Two groups were compared; one received the test minocycline ointment and the other a vehicle control. Both groups had scaling and root planing at baseline, after which the test or control ointments were applied with an applicator into the periodontal pockets at baseline, and at 2, 4, and 6 weeks. Assessment of clinical response was made by measuring probing depth and probing attachment level and gingival bleeding. These measurements were made at baseline prior to scaling and root planing, and at weeks 4 and 12. Microbiological assessment of the subgingival flora was carried out with DNA probes at baseline, and at weeks 2, 4, 6, and 12 to identify and quantify Porphyromonas gingivalis, Prevotella intermedia , and Actinobacillus actinomycetemcomitans . Subgingival minocycline ointment resulted in statistically significantly greater reduction of P. gingivalis at weeks 2, 4, 6, and 12; P. intermedia at weeks 2, 4, 6, and 12; and A. actinomycetemcomitans at weeks 6 and 12. Probing depth reductions were seen for both groups at weeks 4 and 12; however, this reduction was statistically significantly greater in subjects treated with minocycline ointment. Reduction in gingival index and probing attachment gain were seen in both groups, however, the differences between the groups were not statistically significant. In those sites with a baseline probing depth ≥7 mm and a bleeding index >2, the minocycline treatment at 12 weeks resulted in a probing pocket depth reduction of 42% at baseline as compared to 28% at baseline in the control group ( P = 0.0001). Subgingival administration of minocycline ointment was well tolerated. This study demonstrates that repeated subgingival administration of a minocycline ointment as an adjunct to scaling and root planing results in reduction of putative periodontal pathogens, and reduction in probing depth greater than that seen in the control. J Periodontal 1993; 64:637–644 .