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Livfresh Dental Gel for Gum Disease

N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have received definitive treatment (i.e., SRP or periodontal surgical therapy) for periodontitis in the last one year
Must have minimum of 20 natural teeth, excluding third molars
Must not have
Severe dental disease characterized multiple decayed, untreated dental sites
Medical condition that requires pre-medication prior to dental procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if Livionex Dental Gel can help reduce gum disease in patients with moderate to severe periodontitis. The gel aims to improve oral health by preventing bacteria from sticking to teeth, which could be especially helpful for those who haven't fully benefited from standard treatments.

Who is the study for?
Adults over 18 with Stage II or III, Grade B gum disease, at least 20 natural teeth (excluding wisdom teeth), and no recent periodontal treatments or antibiotic/anti-inflammatory use. Participants must not be pregnant, breastfeeding, smokers, have severe systemic diseases like cancer or uncontrolled diabetes, nor be using certain dental products excessively.
What is being tested?
The trial is testing if a novel dental gel called Livionex Dental Gel (LDG) used at home can improve gum health more than the standard fluoride toothpaste when both are added to professional cleaning treatments known as Scaling and Root Planing (SRP).
What are the potential side effects?
While specific side effects of LDG aren't listed in this summary, typical side effects from dental gels may include mouth irritation or allergic reactions to ingredients. It's important for participants to report any unusual oral discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had surgery for gum disease in the last year.
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I have at least 20 natural teeth, not counting wisdom teeth.
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I have moderate to severe gum disease with deep pockets in at least 4 teeth.
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I have at least 20 natural teeth, not counting wisdom teeth.
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I have moderate to severe gum disease with deep pockets in at least 4 teeth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe untreated tooth decay.
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I need medication before any dental work due to a medical condition.
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I have a dental infection that needs treatment during the study.
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I have a disease affecting my mouth's soft or hard tissues.
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I do not have severe systemic diseases or conditions that would prevent proper oral care.
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My gum disease is severe (Stage IV or Grade C).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incremental reduction in gingival pocket depth.
Secondary study objectives
Incremental reduction in Gingival Index
Incremental reduction in Plaque Index
Incremental reduction in the number of Bleeding on Probing (BOP)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Scaling and Root Planing (SRP) + Livfresh Dental Gel (LDG)Experimental Treatment1 Intervention
SRP at Baseline with use of LDG (test dentifrice) for twice daily brushing between study visits.
Group II: Scaling and Root Planing (SRP) + standard fluoride dentifriceActive Control1 Intervention
SRP at Baseline with use of standard fluoride dentifrice (control dentifrice) for twice daily brushing between study visits.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for gum disease, such as mechanical debridement (scaling and root planing), antiseptic mouth rinses, and innovative products like Livionex Dental Gel, primarily work by disrupting the biofilm and reducing the bacterial load in the oral cavity. Mechanical debridement physically removes plaque and tartar from tooth surfaces and beneath the gumline, which helps to reduce inflammation and prevent further bacterial colonization. Antiseptic mouth rinses, containing agents like chlorhexidine, kill bacteria and reduce plaque formation. Livionex Dental Gel, specifically, disrupts the biofilm matrix, making it easier to remove and reducing the bacterial load more effectively. These mechanisms are crucial for gum disease patients as they help to control infection, reduce inflammation, and prevent the progression of periodontal disease, ultimately preserving oral health and preventing tooth loss.
Bioenergetics in clinical medicine. VI. adjunctive treatment of periodontal disease with coenzyme Q10.Clinical and microbiological patterns of adults with periodontitis.Are adjunctive therapies effective in reducing gingivitis and plaque?

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,640 Previous Clinical Trials
2,332,014 Total Patients Enrolled

Media Library

SRP + Livfresh Dental Gel Clinical Trial Eligibility Overview. Trial Name: NCT05384132 — N/A
Gum Disease Research Study Groups: Scaling and Root Planing (SRP) + Livfresh Dental Gel (LDG), Scaling and Root Planing (SRP) + standard fluoride dentifrice
Gum Disease Clinical Trial 2023: SRP + Livfresh Dental Gel Highlights & Side Effects. Trial Name: NCT05384132 — N/A
SRP + Livfresh Dental Gel 2023 Treatment Timeline for Medical Study. Trial Name: NCT05384132 — N/A
~24 spots leftby Oct 2025