Actively Recruiting
Randomized Control Trial of a Novel Dental Gel as an Adjunct to Scaling and Root Planing in Adults With Stage II and III Periodontitis
Led by University of Alabama at Birmingham · Updated on 2025-12-17
76
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Livionex Dental Gel (LDG) as a home care product alongside standard scaling and root planing (SRP) treatment to reduce probing pocket depth in patients with stage II and III periodontitis. This randomized, single-blind study aims to assess whether LDG can provide additional benefits in controlling plaque and improving gum health beyond the effects of SRP alone. The study is sponsored by the University of Alabama at Birmingham and focuses on adult participants with moderate to advanced periodontal disease. Participants receive SRP at the start of the study to physically remove plaque, tartar, and bacterial toxins from affected teeth. They are then assigned to use either LDG or a standard fluoride toothpaste twice daily for six months. Both dentifrices are used with toothbrushing for two minutes each time. LDG contains an ingredient called EDTA that may prevent bacterial plaque from sticking to teeth, which is being studied for its potential to reduce plaque and gingival inflammation. During the study, participants will have their gum health monitored through measurements like probing pocket depth, gingival index, plaque index, and bleeding on probing at baseline and after six months. Researchers will also track adherence to the brushing routine and evaluate safety throughout the trial. The total participation time is six months, during which oral hygiene and periodontal status are regularly assessed to understand the impact of the dental gels when used as part of daily home care.
CONDITIONS
Brief Title
Novel Dental Gel as an Adjunct to Scaling and Root Planing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects at least 18 years old
- Willing and able to provide written informed consent
- Available for the duration of the study and follow-up by telephone
- Have at least 20 natural teeth, excluding third molars
- Have at least 20 bleeding on probing (BOP) sites, excluding third molars
- Diagnosed with stage II or III, Grade B periodontitis with at least 4 teeth having probing depth of 5 mm or more and clinical attachment loss of 3 mm or more
- No antibiotic therapy for periodontal disease or chronic use of anti-inflammatory drugs within one month before baseline or during the study
- No scaling and root planing or periodontal surgery within the past year
- Able to comply with study visits and able to read and understand English consent form
- Willing to use a manual toothbrush during the study
You will not qualify if you...
- Pregnant or breastfeeding
- Medical conditions requiring pre-medication before dental procedures
- Systemic conditions or medications affecting periodontal tissues
- Severe dental disease with multiple decayed or untreated sites
- Presence of orthodontic appliances
- Diseases of oral soft or hard tissues
- Current participation in another clinical trial or recent participation within one month
- Stage IV or Grade C periodontitis
- Vertical bone defects 4 mm or greater
- Active dental infections other than periodontitis requiring treatment during study
- Excessive oral hygiene practices including use of water irrigation devices or interdental cleansers more than twice daily
- Non-English speaking
- Smokers, uncontrolled or brittle diabetics, HIV/AIDS, or severe systemic diseases affecting oral hygiene
- History of allergic reaction to ingredients in test or control dentifrices
- Conditions or situations preventing compliance with study or affecting data quality
- Unwilling to use manual toothbrush during the study
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive scaling and root planing (SRP) at baseline and then use either the novel dental gel or a standard fluoride dentifrice twice daily for toothbrushing over the course of the study.
Multiple visits during the 6 months for study assessments
Trial Site Locations
Total: 1 location
1
Unversity of Alabama at Birmingham, School of Dentistry
Birmingham, Alabama, United States, 35294-0007
Actively Recruiting
Research Team
M
Maninder Kaur, BDS,MPH,MS
S
Sarah Startley, DMD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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