Novel Dental Gel as an Adjunct to Scaling and Root Planing

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · May 17, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new dental gel called Livionex Dental Gel (LDG) to see if it can help improve gum health for people with periodontitis, a serious gum disease. The study aims to find out if using this gel at home can further reduce the depth of gum pockets beyond what is achieved with the standard treatment known as scaling and root planing (SRP). Participants will be asked to use the dental gel along with their regular care routine.

To join the study, participants must be at least 18 years old, have at least 20 natural teeth, and be diagnosed with a specific stage of periodontitis. They should not have had recent treatment for their gum disease and should not be taking certain medications that could affect their gums. During the study, participants can expect to visit the dental office for check-ups and will also need to be available for follow-up phone calls. This is a great opportunity for those looking to improve their gum health with new treatments.

Gender

ALL

Eligibility criteria

• 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 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.