Introduction
Management of periodontitis has in recent times shifted to the use of subantimicrobial dose doxycycline (SDD), usually at a dose of 20mg twice daily. SDD is in most cases used in conjunction with scaling and root planing (SRP) in the management of periodontitis. Studies have shown greater efficacy when the combination is used. SDD exerts its antimicrobial activity through inhibition of matrix metalloproteins (MMPs) activity. Inflammatory cells that occur in periodontal disease are implicated in the production of MMPs and these MMPs are major pathogenetic mediators in periodontal disease.
The treatment usually lasts for a period of between three to nine months with the administration of 20mg of SDD twice daily. The pill burden of taking medication daily may result in decreased compliance with the SDD medication. To address this problem, modified-release drug formulations are needed to ensure once-daily dosing and as such increase compliance to medication. A modified-release system for SDD has been put in place.
This system contains 40mg of doxycycline monohydrate in a capsule and is designed in such a way that it can release the active ingredient over 24 hours and as such facilitate once-daily dosing. This study aims at determining the efficacy of SDD-40 when used together with SRP in the management of periodontal disease in comparison to a placebo. In addition, the levels of subgingival flora were assessed over 9 months to determine the effect of SDD-40 on this type of flora when compared to a placebo (Preshaw et al., 2008).
Methodology
Study Design
The study was a randomized, multicenter, double-masked, placebo-controlled study. The study was carried out over nine and a half months. It entailed a two-week screening procedure to identify participants suitable to be enrolled in the study. There was a random designation of participants to either the SDD-40 group or to the placebo group. The participants were required to take either the placebo or the SDD-40 for nine months.
Participants
Inclusion criteria entailed the selection of males and females who were 18 years or older at the time of screening. In addition, for the participant to be included in the study, one should have had untreated periodontal disease. On the other hand, exclusion criteria included expectant women, those with chronic conditions, and any form of dental prophylaxis in the 30 days leading to the screening process. In addition, those participants who had allergies or hypersensitivity to tetracyclines were excluded from taking part in the study.
Procedures and Measures
There was all-inclusive training for all individuals who were to work as examiners in the study. To reduce variability, the same examiner was required to follow the same participant throughout the study. Before the commencement of the study, the clinical attachment level (CAL) and PD of the participants were assessed and recorded, and quantified on a scale of 0-3 based on the University of North Carolina manual. The presence of periodontal disease was confirmed by the use of radiographs.
To exclude any pregnant women taking part in the study, all-female participants underwent a pregnancy test. Other personal habits such as smoking, oral cleanliness, and other parameters were recorded. A total of 266 participants met the inclusion criteria and were then randomized to either the SDD-40 group or to the placebo group.
The participants were then educated on the possibility of interaction of doxycycline and drugs containing metal ions. Various parameters were recorded at 0, 3, 6, and 9 months. These are PD, CAL, and BOP. Pill count was the method used in the determination of the extent of compliance to medication/placebo. Microbiological determinations were carried out to assess the levels of subgingival flora after initiation of treatment with SDD-40 and placebo in both arms of the study.
Data Analysis
For those participants in the SDD-40 arm, intent to treat analysis of the obtained data was carried out. The missing data was catered for by performing a last-observation-carried-forward (LOCF) imputation. Other statistical analyses such as ANCOVA were carried out on the obtained data.
Compliance and non-compliance were determined based on a preset definition that encompassed several doses and days. Non-compliance was set at a compliance rate equal to or less than 80%. For microbiological analyses, inferential doxycycline resistance by the microbes was determined at various points during the period of study. Analysis entailed the use of non-parametric tests.
Results
There were no statistically significant differences in various parameters such as oral cleanliness and demography. 92% compliance was recorded for the SDD-40 arm while 95% compliance was for the placebo arm. Baseline characteristics in both arms were analogous. The SDD-40 arm exhibited massive gains in CAL as compared to the placebo arm of the study. Furthermore, large decreases in PD were observed in the SDD-40 arm as compared to the placebo group.
For BOP, the SDD-40 arm had a greater decrease in all sites except in deep sites where there was no difference in the two arms of the study. Microbiological analyses showed that more participants in the SDD-40 arm showed greater doxycycline resistance as compared to those in the placebo arm.
Conclusion
From the study, it is clear that the use of SDD-40 in tandem with SRP has better outcomes in terms of CAL and PD in comparison to the employment of SRP alone in the management of the periodontal disease. In addition, the study shows that there was a great enhancement in the rate of compliance with SDD-40 as compared to data from studies using SDD-20. The study also shows that in the long run, SDD-40 has little impact on the levels of microorganisms. The use of SRP in conjunction with SDD-40 brings about more good than harm.
References
Preshaw, P., Novak, M., Mellonig, J., Magnusson, I., Polson, A., Giannobile, W., et al. (2008). Modified-release subantimicrobial dose doxycycline enhances scaling and root planning in subjects with periodontal disease. Journal of Periodontology, 79(3), 440-452.