Novel Dental Gel as an Adjunct to Scaling and Root Planing

Recruiting now · Not applicable

Conditions studied: Periodontal Diseases, Gingival Diseases, Gingival Pocket, Gum Bleed, Plaque, Dental

In brief

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.

Key facts

Study ID: NCT05384132
Run by: University of Alabama at Birmingham
People needed: 76
Starts: 2022-10-14
Expected to finish: 2028-10-30
Last updated by the study team: 2025-12-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

Unversity of Alabama at Birmingham, School of Dentistry — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.