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Novel Dental Gel as an Adjunct to Scaling and Root Planing

RecruitingNAAges 18 Years - 85 YearsAllUniversity of Alabama at Birmingham
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In plain words

What the trial is, and whether it could suit you

This study will evaluate the use of Livionex Dental Gel (LDG) as a home care product in reducing probing pocket depth (PD) beyond the effect achieved by the current standard of care with SRP in periodontitis patients.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or female subjects at least 18 years of age. * Subject must be willing and able to provide written informed consent. * Available during the course of the study. * Must have minimum of 20 natural teeth, excluding third molars. * Must have at least 20 BOP sites, excluding third molars. * Stage II or III, Grade B periodontitis with at least 4 teeth with a minimum PD of 5 mm and minimum CAL of 3mm. * No antibiotic therapy for periodontal disease or chronic use of anti-inflammatory drugs (NSAIDs) within the past month of Baseline, or during the study. * Must not have received definitive treatment (i.e., SRP or periodontal surgical therapy) for periodontitis in the last one year. * Subject must be willing and able to comply with study visits as described in the protocol. * Subjects must be available for follow up on the telephone. * Able to read and understand the consent form in English Exclusion Criteria: * โ€ข Pregnancy or breast feeding. * Medical condition that requires pre-medication prior to dental procedures. * Systemic conditions and use of medications that may affect periodontal tissues. * Severe dental disease characterized multiple decayed, untreated dental sites. * Presence of orthodontic appliances. * Diseases of oral soft or hard tissues. * Participating in another clinical trial currently or in the month preceding this study. * Stage IV and/or Grade C periodontitis. * Vertical bone defects 4mm or greater. * Subjects who have active dental infections other than periodontitis that will require dental treatment during the study period. * Excessive oral hygiene practices including use of water irrigation devices such as Waterpik or use of interdental cleansers more than twice daily. * Non-English speaking * Smokers, uncontrolled or brittle diabetics, HIV/AIDS, and subjects with severe systemic disease, e.g., cancer, lupus, pemphigus vulgaris/pemphigoid, or other oral mucous membrane diseases that would interfere with performance of oral hygiene, e.g., erosive lichen planus, recurrent major aphthous lesions, etc. * History of allergic reaction to any ingredient in the test/control dentifrices. * Presence of any condition, abnormality, or situation at Baseline that in the opinion of the Principal Investigator may preclude the subject's ability to comply with study requirements, including completion of the study or the quality of the data. * Subjects unwilling to use manual toothbrush during the study.
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What it tests

  • SRP + Livfresh Dental Gel
  • SRP + standard flouride dentifrice
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Where

1 site
Unversity of Alabama at Birmingham, School of Dentistry
Birmingham, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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