J&J CONDUCTS THE FIRST EVER DHCP-POWERED CLINICAL RESEARCH

Dental research is nothing new. Almost every oral health brand runs some form of research to claim product safety and verify efficacy. Over the last 20 years, J&J alone has conducted thirteen 6-month studies with the involvement of over 4166 subjects, and ten 3-month studies involving 2331 subjects.

What is new, however, is the approach designed and taken by J&J in a recent clinical study. By strictly following the protocol set forth by the American Dental Association and by engaging daily dental care professional (DHCP) supervision, this clinical trial has raised the bar in oral health research standards.

Although Johnson & Johnson developed the criteria and controls of the study, placing it in an independent clinical research facility was critical to the credibility of the outcomes.

For clinical and or laboratory research conducted at external testing sites, J&J, voluntarily applied for qualified status evaluation through the ADA Seal of Acceptance Program. For the qualification evaluation, a select team of dental experts inspected the facility, reviewed the accuracy of data collection procedures, and determined the experience and training of directors and staff. Once the testing site met these strict criteria and only then, did it earn qualified status.

ONLY FIVE SITES ARE QUALIFIED UNDER ADA GUIDELINES

Currently in the United States, there are only 5 independent research sites qualified under the ADA Independent Research Testing Site Program guidelines. For the recent clinical trials, one of these sites was chosen by J&J to conduct the study. Because the research was done exclusively at an external clinic, the data collected offers an unbiased perspective into the benefits of a comprehensive oral routine that combines brushing and flossing with the use of mouth rinse.

FOLLOWING ADA STANDARDS

To ensure that the results are grounded in fact and measured data, J&J has always maintained a strict adherence to the standards set forth by the American Dental Association—as well as the guidelines provided by the US Department of Health and Human Services (HHS).

The ADA Seal of Acceptance has been the leading mark of dental product safety and efficacy for 90 years AND HAS STRICT GUIDELINES TO ACHIEVE BEFORE THE ADA SEAL IS APPROVED.

GOOD CLINICAL PRATICAL GUIDANCE

Another important guidance tool for dental research is The Good Clinical Practice (GCP) guidance, published by the HHS and the FDA. GCP is a highly respected international ethical and scientific quality standard used in clinical trials.

WHAT GCP MEANS FOR ORAL CARE RESEARCH

Following GCP guidelines provides assurance that data and reported results are credible and accurate. It also ensures that the rights, integrity, and confidentiality of trial subjects are respected and protected, and that their safety and well-being are protected as well.

At the onset of the clinical trial a dental prophylaxis and baseline examinations, (including oral soft tissue tolerance and probing depths), were performed. After establishing an equal standing in oral hygiene, the 156 subjects were randomized into four distinct groups:

1. Rinse with a control mouthrinse containing 5% hydroalcohol
2. Rinse with LISTERINE® Antiseptic Cool Mint®
3. Professional flossing by a dental hygienist
4. Self-flossing under supervision

All groups were required to brush with flouride dentrifice prior to using their assigned regimen. Once daily, for 5 days, all subjects in all four groups performed their first daily use of the assigned regimen on the site under direct hygienist and dental expert supervision.

After flossing instructions were given and subjects demonstrated oral health competency, the subjects performed the second daily hygiene regimen unsupervised at home. At the 4th and 12th weeks of the study, follow-up assessments with dental experts took place back at the research clinic. As a result of this new disciplined and DHCP-powered method of research, the data unequivocally proved that a complete routine of brushing, flossing, and rinsing with LISTERINE® Antiseptic is superior to brushing and flossing for plaque and gingivitis control. Dr Mary Lynn Bosma, said this about the study, “These findings indicate and lend further support to the essentiality of twice-daily rinsing in your oral hygiene regime of brushing and flossing.” Having the data to share with dental professionals not only helps them make evidence-based clinical decisions, but it also instills confidence that adding LISTERINE® Antiseptic to a patient’s oral hygiene regimen could greatly reduce the likelihood of plaque build-up, gingivitis, and bad-breath.

PROTOCOLS, PRECISION AND PROOF, THE J&J WAY

As a company, Johnson & Johnson believes that quality products should always come with the most accurate and credible clinical proof. New findings like the ones revealed in this study can lead to collaborations with the dental community that drive reinformed comprehensive hygiene practices.

Study protocols are designed to secure the quality in every stage of the product research and reporting process. Quality and responsibility are within J&J’s core tenets. Most importantly, guidelines serve as a guarantee in the safety of the participants in the study. Thanks to the tenacity of Gold Standard in establishing clinical trials and the results it produces, dental health care professionals can be confident in the credibility of the data, both in respect to the outcome and the collective experiences of the test subjects. The hope is that through continuous, innovative, rigorous, and robust research practices and the indisputable data it uncovers, oral health will become a ubiquitous part of overall health.

As a reminder, whenever you are reviewing dental research, be sure to check whether ADA guidelines were followed at testing locations. This will help you make the kind of evidence-based decisions, backed by science, that is in the best interest of your patients.

*Contact the ADA for more information on the ADA Seal of Acceptance Program and to obtain Seal guidelines.