TY - JOUR
T1 - Efficacy of sub-antimicrobial dose doxycycline in post-menopausal women
T2 - Clinical outcomes
AU - Reinhardt, Richard A.
AU - Stoner, Julie A.
AU - Golub, Lorne M.
AU - Wolff, Mark S.
AU - Lee, His Ming
AU - Meinberg, Trudy A.
AU - Lynch, James C.
AU - Ryan, Maria E.
AU - Sorsa, Timo
AU - Payne, Jeffrey B.
PY - 2007/9
Y1 - 2007/9
N2 - Aims: 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. Materials and 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%, 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
AB - Aims: 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. Materials and 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%, 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
KW - Osteopenia
KW - Periodontal maintenance
KW - Periodontitis
KW - Post-menopausal
KW - Randomized clinical trial
KW - Relative clinical attachment
KW - Sub-antimicrobial dose doxycycline
UR - http://www.scopus.com/inward/record.url?scp=34548099750&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34548099750&partnerID=8YFLogxK
U2 - 10.1111/j.1600-051X.2007.01114.x
DO - 10.1111/j.1600-051X.2007.01114.x
M3 - Article
C2 - 17716312
AN - SCOPUS:34548099750
SN - 0303-6979
VL - 34
SP - 768
EP - 775
JO - Journal of Clinical Periodontology
JF - Journal of Clinical Periodontology
IS - 9
ER -