Novel Dental Gel as an Adjunct to Scaling and Root Planing (NCT05384132) | Clinical Trial Compass
RecruitingNot Applicable
Novel Dental Gel as an Adjunct to Scaling and Root Planing
United States76 participantsStarted 2022-10-14
Plain-language summary
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.
Who can participate
Age range18 Years – 85 Years
SexALL
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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:
* • 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 grea…