A 15-month evaluation of the effects of repeated
subgingival minocycline in chronic adult periodontitis.
van Steenberghe D, Rosling B, Soder PO, Landry RG, van der Velden U,
Timmerman MF, McCarthy EF, Vandenhoven G, Wouters C, Wilson M, Matthews J,
Newman HN.
Catholic University, Leuven, Belgium.
BACKGROUND: A double-blind, randomized, parallel, comparative study was
designed to evaluate the long-term safety and efficacy of subgingivally
administered minocycline ointment versus a vehicle control. METHODS: One
hundred four patients (104) with moderate to severe adult periodontitis (34
to 64 years of age; mean 46 years) were enrolled in the study. Following
scaling and root planing, patients were randomized to receive either 2%
minocycline ointment or a matched vehicle control. Study medication was
administered directly into the periodontal pocket with a specially designed,
graduated, disposable applicator at baseline; week 2; and at months 1, 3, 6,
9, and 12. Scaling and root planing was repeated at months 6 and 12.
Standard clinical variables (including probing depth and attachment level)
were evaluated at baseline and at months 1, 3, 6, 9, 12, and 15.
Microbiological sampling using DNA probes was done at baseline; at week 2;
and at months 1, 3, 6, 9, 12, and 15. RESULTS: Both treatment groups showed
significant and clinically relevant reductions in the numbers of each of the
7 microorganisms measured during the entire 15-month study period. When
differences were detected, sites treated with minocycline ointment always
produced statistically significantly greater reductions than sites which
received the vehicle control. For initial pockets > or =5 mm, a mean
reduction in probing depth of 1.9 mm was seen in the test sites, versus 1.2
mm in the control sites. Sites with a baseline probing depth > or =7 mm
and bleeding index >2 showed an average of 2.5 mm reduction with
minocycline versus 1.5 mm with the vehicle. Gains in attachment (0.9 mm and
1.1 mm) were observed in minocycline-treated sites, with baseline probing
depth > or =5 mm and > or =7 mm, respectively, compared with 0.5 mm
and 0.7 mm gain at control sites. Subgingival administration of minocycline
ointment was well tolerated. CONCLUSIONS: Overall, the results demonstrate
that repeated subgingival administration of minocycline ointment in the
treatment of adult periodontitis is safe and leads to significant adjunctive
improvement after subgingival instrumentation in both clinical and
microbiologic variables over a 15-month period.