New Clinical Study Reveals OraPharma’s ARESTIN(R) Microspheres Could Lower Risk of Periodontitis-Causing Pathogens in Adults.

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its oral health care division, OraPharma, Inc., have recently published the results of a new study which showed that ARESTINĀ® (minocycline HCI) microspheres, 1mg can help reduce infection burdens in adults with periodontitis, provided the treatment is applied immediately after scaling and root planning (SRP) and again at three-month intervals.

ARESTIN is an FDA-approved antibiotic which, when used in conjunction with an overall oral health program, has been proven to be an effective way of addressing periodontal issues. However, it is important to note that ARESTIN should not be used by those who are allergic to minocycline or tetracyclines.

The University of Minnesota School of Dentistry has released a study published in the Journal of Periodontology, which was partially sponsored by Bausch Health. The study found that when minocycline was applied right after initial scaling and root planing (SRP) and then reapplied three months later, certain key pathogens were reduced and improvements in probing depth (PD), clinical attachment loss (CAL), bleeding on probing (BOP) and gingival index (GI) were observed compared to SRP alone.

With the emergence of new research on the link between periodontal disease and systemic outcomes such as diabetes and cardiovascular disease, dental practices must be proactive in understanding and managing the keystone pathogens that originate in the mouth and can travel throughout the body.

According to Richard Nagelberg, DDS, Director of Medical Affairs at Bausch Health, this study is a crucial step forward in understanding the progression of periodontal disease and its potential oral-systemic connection. It is his hope that this study will spur further investigation in this area and help to provide better care for patients suffering from periodontal disease.

This study investigated the effects of minocycline HCI microspheres, 1mg on periodontal pathogens and found that the administration of this drug significantly reduced the presence of the targeted pathogens.

Prior to this trial, there was a lack of evidence on the efficacy of minocycline for this purpose, however this research has filled the gap in the literature and is an important step in advancing our understanding of periodontal health.

This study investigated the potential effect of adding minocycline HCl microspheres to scaling and root planing (SRP) for the treatment of periodontal disease. Saliva samples and clinical outcomes were collected for both groups (those who received SRP alone and those who received SRP plus minocycline microspheres) at baseline before SRP, 1-month reevaluation, and at 3 and 6-month periodontal recall.

The results showed that minocycline HCl plus SRP had a statistically significant decrease in six periodontal pathogens at 1-month and four periodontal pathogens at 6-month periodontal maintenance compared to the SRP group alone.

Furthermore, the minocycline HCI plus SRP group also achieved greater improvement in probing depth, bleeding on probing, gingival index, and clinical attachment loss by the six-month periodontal maintenance versus SRP alone. These findings demonstrate the potential for minocycline HCl microspheres to be an effective adjunct therapy to SRP for the treatment of periodontal disease.

The present study, although limited by the lack of a blinded examiner for clinical outcomes and the absence of patient-reported outcome measures, provided valuable insights into the efficacy of a novel treatment for periodontitis.

A total of 50 participants, predominantly from the Midwestern region, Caucasian and over the age of 50 years old, were recruited for the study. Saliva samples, clinical measures and treatment were provided by the principal investigator for both groups. The results of this study will help to improve the care provided for individuals suffering from periodontitis.

Dr. Nagelberg found that the combination of SRP and minocycline HCl microspheres saw a marked decrease in Tannerella forsythia, Treponema denticola, Fusobacterium nucleatum/periodonticum, Prevotella intermedia, Parvimonas micra and Eikenella corrodens after 1 month of treatment. This was especially prominent when minocycline HCl microspheres were administered immediately following SRP procedures.

In a study conducted by Williams et al. (2001), it was determined that combining minocycline HCI with SRP could significantly reduce pocket depth in patients with generalized moderate to advanced adult periodontitis.

At nine months after initial treatment, those treated with minocycline HCI plus SRP had a statistically significant reduction in probing pocket depth compared to those in the control group who only received SRP or SRP + vehicle. The results of this study demonstrate the effectiveness of minocycline HCI in reducing pocket depth.

About the Study

This study aimed to investigate the effects of an adjunctive minocycline HCl microspheres (MM) treatment on periodontal parameters such as probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and gingival index (GI) following a scaling and root planing (SRP) procedure.

A total of 70 participants were randomized to receive SRP alone or SRP with MM, and periodontal evaluations were conducted at baseline, one month, three months, and six months following the initial SRP procedure. Additionally, the relative numbers of 11 periodontal pathogens in saliva were determined before and after SRP+MM to assess the bacterial load and pathogenic burden.

To examine the differences between groups in terms of microbial presence and secondary periodontal measurements, we employed a generalized linear mixed-effects model with fixed effects for group, visit, and site (for clinical measurements).

We also included group-by-visit and group-by-site interactions, as well as random effects for participant and site within participant. By comparing the mean changes from baseline between groups, we were able to assess the significance of the group-by-visit interaction tests.

The results of the study showed that the test group displayed a statistically significant decrease in six periodontal pathogens at the one-month follow-up visit, including Tannerella forsythia (Tf), Treponema denticola (Td), Fusobacterium nucleatum/periodonticum (Fn/Fp), Prevotella intermedia (Pi), Parvimonas micra (Pm), and Eikenella corrodens (Ec).

Furthermore, a decrease in four periodontal pathogens was also observed in the test group at the six-month visit, including Fn/Fp, Pi, Campylobacter rectus (Cr), and Ec. These results demonstrate the effectiveness of the tested treatment in reducing the levels of periodontal pathogens.

This study had several limitations, such as the absence of a blinded examiner for clinical outcomes and patient-reported outcome measures. Additionally, the sample size was largely comprised of Caucasian individuals over the age of 50 from the Midwestern region, which does not accurately reflect the general population of people with periodontitis. The principal investigator was responsible for collecting saliva samples, recording clinical measurements, and providing treatment to both groups.

The National Institutes of Health’s National Center for Advancing Translational Science provided generous support for the statistical analysis used in this research, helping to further explore and understand the results.

Leave a Comment