Efficacy of sub-antimicrobial dose doxycycline in post-menopausal women: clinical outcomes.
OBJECTIVE
To determine the clinical efficacy of a 2-year continuous sub-antimicrobial dose doxycycline (SDD; 20 mg bid) in post-menopausal, osteopenic, oestrogen-deficient women on periodontal maintenance.


METHODS
One-hundred and twenty-eight subjects were randomized to SDD (n=64) or placebo (n=64). Clinical measurements were performed at posterior interproximal sites at baseline and every 6 months during this 2-year randomized, double-blind, placebo-controlled clinical trial with adjunctive, no-cost 3-4-month periodontal maintenance. Statistical analyses of secondary outcomes from this clinical trial used Generalized Estimating Equations in primarily intent-to-treat analyses.


RESULTS
For the placebo group, 3.4% of the sites showed improvement in clinical attachment levels (CAL) and 2.7% had progressive loss in CAL; for the SDD group, 5.0% of the sites showed an improvement in CAL and 2.2% had progressive loss in CAL. This difference (2.1% of sites) was more favourable in the SDD group than in the placebo [odds ratio (OR)=0.81 [corrected] 95% confidence interval (CI): 0.67-0.97, p=0.03] in these well-maintained patients, whereas probing depths, bleeding on probing and supragingival plaque did not differ significantly between groups (p>0.2). However, in exploratory subgroup analysis of non-smokers, SDD showed reduced bleeding versus placebo (27%versus 33%; p=0.05). In protocol-adherent subjects, the odds of bleeding were 34% lower for SDD (p=0.05).


CONCLUSIONS
Analyses of secondary outcomes of this clinical trial indicated that SDD may be of benefit in reducing progressive attachment loss in post-menopausal females; additional research is needed to confirm these findings. Protocol registered at (ClinicalTrials.gov). Identifier:NCT00066027.
Reinhardt
Richard A
RA
Department of Surgical Specialties, University of Nebraska Medical Center College of Dentistry, Lincoln, NE 68583-0740, USA. rareinha@unmc.edu
Stoner
Julie A
JA
Golub
Lorne M
LM
Wolff
Mark S
MS
Lee
Hsi-Ming
HM
Lee
His-Ming
HM
Meinberg
Trudy A
TA
Lynch
James C
JC
Ryan
Maria E
ME
Sorsa
Timo
T
Payne
Jeffrey B
JB
D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001851:Bone Diseases, Metabolic / Q000150:complications; D003773:Dental Plaque / Q000517:prevention & control; D004311:Double-Blind Method; D004318:Doxycycline / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D005884:Gingival Hemorrhage / Q000517:prevention & control; D006801:Humans; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications; D017622:Periodontal Attachment Loss / Q000517:prevention & control; D010510:Periodontal Diseases / Q000517:prevention & control*; D010514:Periodontal Pocket / Q000517:prevention & control; D010518:Periodontitis / Q000517:prevention & control; D010919:Placebos; D017698:Postmenopause; D012907:Smoking; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D010919:Placebos; D004318:Doxycycline
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