Status:
RECRUITING
Novel Dental Gel as an Adjunct to Scaling and Root Planing
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Periodontal Diseases
Gingival Diseases
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 period...
Detailed Description
The current standard of care in treating periodontitis is scaling and root planing (ScRP). ScRP is the instrumentation of the crown and root surfaces of teeth to remove plaque, tartar, and stains, as ...
Eligibility Criteria
Inclusion
- 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
- • 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.
Key Trial Info
Start Date :
October 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2028
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT05384132
Start Date
October 14 2022
End Date
October 30 2028
Last Update
December 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Unversity of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, United States, 35294-0007