Novel Trial to Study the Reduction of Certain Pathogens Following Scaling and Root Planing Procedure
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its oral health care business, OraPharma, today announced the publication of a new study, which showed that ARESTIN® (minocycline HCI) microspheres, 1mg decreased certain pathogenic burdens, also known as infection burdens, in adults with periodontitis when applied immediately after scaling and root planning (SRP) and again at a three-month reapplication, versus SRP alone. ARESTIN is an FDA-approved antibiotic applied locally to gum pockets in adults with periodontitis following an SRP procedure and is used as part of an overall oral health program. ARESTIN should not be used in people who are allergic to minocycline or tetracyclines.
The investigator-initiated trial, sponsored in part by Bausch Health, and conducted by researchers from the University of Minnesota School of Dentistry, appeared today in the Journal of Periodontology. The study showed minocycline application immediately after initial SRP and reapplication at 3-months after SRP decreased certain key pathogens and may have contributed to improvements in probing depth (PD), clinical attachment loss (CAL), bleeding on probing (BOP) and gingival index (GI) compared to SRP alone.
"Dental practices need to think about periodontal disease and the role of keystone pathogens that originate in the mouth, can travel, and may be associated with other systemic outcomes such as diabetes and cardiovascular disease," said Richard Nagelberg, DDS, Director of Medical Affairs at Bausch Health. "This study represents an important path forward in helping to manage periodontal disease and we hope it encourages further research in the area of periodontal disease progression and how it may relate to the oral-systemic connection."
Since the pivotal trial, there was a gap in the literature on whether minocycline HCI microspheres, 1mg reduced specific periodontal pathogens. This study identified that the administration of minocycline HCI microspheres, 1mg did significantly decrease specific periodontal pathogens.
The objective of the study entitled, "Effect of Scaling and Root Planing With and Without Minocycline HCl Microspheres on Periodontal Pathogens and Clinical Outcomes: A Randomized Clinical Trial," was to determine if minocycline HCl plus SRP contributed to the improvement of certain clinical measures commonly seen in patients with gum disease. A secondary endpoint was to determine if minocycline microspheres HCl with SRP lowered specific pathogens responsible for periodontitis compared to SRP alone. Saliva and clinical outcomes were collected for both groups at baseline before SRP, 1-month reevaluation, and at 3 and 6-month periodontal recall. Minocycline microspheres (MM) were delivered to pockets ≥5 mm immediately after SRP and immediately after the 3-month periodontal maintenance. This study reported that of the 11 pathogens that play an instrumental role in periodontitis, there were six periodontal pathogens that had a statistically significant decrease at 1-month and four periodontal pathogens with a statistically significant decrease at the 6-month periodontal maintenance versus the SRP group alone. This study also reported that minocycline HCI plus SRP achieved greater improvement for probing depth, bleeding on probing, gingival index, and improvement in clinical attachment loss by the six-month periodontal maintenance versus SRP alone.
Limitations of the study include the lack of a blinded examiner for clinical outcomes and lack of patient-reported outcome measures. The principal investigator (PI) collected saliva, recorded clinical measures and provided treatment for both groups. The participants in this study were predominantly from the Midwestern region, Caucasian and over the age of 50 years old, which does not represent the general population of individuals with periodontitis.
"There was a larger decrease of Tannerella forsythia, Treponema denticola, Fusobacterium nucleatum/periodonticum, Prevotella intermedia, Parvimonas micra and Eikenella corrodens in the SRP + MM group," said Dr. Nagelberg. It is notable that minocycline HCl microspheres, 1mg immediately following SRP procedures reduced these specific periodontal pathogens by the 1-month reevaluation.
The previous pivotal study (Williams et al., 2001) was conducted to determine if minocycline HCI plus SRP reduced pocket depth in patients with generalized moderate to advanced adult periodontitis versus SRP alone. Subjects treated with minocycline HCI plus SRP were found to have statistically significantly reduced probing pocket depth compared with those treated with SRP alone or SRP + vehicle at 9 months after initial treatment.
About the Study
A total of 70 participants were randomized to receive SRP alone, or SRP with minocycline HCl microspheres, 1mg following the procedure, and again at the 3-month periodontal visit. Participants in both groups received periodontal evaluations at baseline, one month, three months and six months following the initial SRP procedure. The primary goal of this study was to determine the adjunctive effects of minocycline microspheres (MM) on clinical outcomes of PD, CAL, BOP, and GI after SRP+MM compared to SRP alone. Secondary outcome variables were the relative numbers of 11 periodontal pathogens in saliva after SRP+MM compared to SRP alone. The bacterial load and pathogenic burden were determined using a salivary test.
Microorganisms and secondary periodontal measurements were compared between groups using generalized linear mixed-effects models, with fixed effects for group, visit, site (for clinical measurements), and group-by-visit and group-by-site interactions, and random effects for participant and site within participant. Mean changes from baseline were compared between groups via group-by-visit interaction tests.
The six periodontal pathogens observed in the test group to have a statistically significant decrease compared to the SRP alone group at the one-month follow-up visit were Tannerella forsythia (Tf) (0.003), Treponema denticola (Td) (0.01), Fusobacterium nucleatum/periodonticum (Fn/Fp)(0.0009), Prevotella intermedia (Pi) (0.04), Parvimonas micra (Pm) (<0.0001), and Eikenella corrodens (Ec) (0.02). Further, the four periodontal pathogens observed in the test group to have a statistically significant decrease compared to the SRP alone group at the final six-month visit were Fusobacterium nucleatum/periodonticum (Fn/Fp) (0.02), Prevotella intermedia (0.05), Campylobacter rectus (Cr) (0.04) and Eikenella corrodens (0.0002).
Limitations of the study include the lack of a blinded examiner for clinical outcomes and lack of patient-reported outcome measures. The principal investigator (collected saliva, recorded clinical measures and provided treatment for both groups. The participants in this study were predominantly from the Midwestern region, Caucasian and over the age of 50 years old, which does not represent the general population of individuals with periodontitis.
The statistical analysis for this research was supported by a grant from the National Institutes of Health's National Center for Advancing Translational Science.
