What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for gum disease, such as scaling and root planing, antimicrobial mouthwashes, and dental gels like Livionex Dental Gel, generally aim to disrupt biofilm and reduce bacterial load. Side effects of these treatments can include temporary tooth sensitivity, gum discomfort, and minor bleeding. Antimicrobial mouthwashes may cause altered taste, staining of teeth, and oral mucosal irritation. Dental gels are typically well-tolerated, but some patients may experience mild irritation or allergic reactions. Overall, these treatments are considered safe with manageable side effects.

What prior FDA approvals exist?

FDA-approved treatments for gum disease that focus on disrupting biofilm and reducing bacterial load include antimicrobial mouth rinses like chlorhexidine, which is often prescribed to control plaque and gingivitis. Additionally, antibiotics such as doxycycline in sub-antimicrobial doses (Periostat) have been approved to reduce the bacterial load and inflammation in periodontal disease. These treatments aim to manage the microbial component of gum disease, similar to the mechanism of action proposed for Livionex Dental Gel.

What other types of research exist?

Promising alternatives to Livionex Dental Gel for gum disease treatment include: 1) Chlorhexidine mouthwash, which is effective in reducing bacterial load and biofilm. 2) Essential oil-based mouthwashes, such as those containing thymol, eucalyptol, and menthol, which have antimicrobial properties. 3) Probiotic dental products that help balance oral microbiota. 4) Dental gels or rinses containing cetylpyridinium chloride, which has been shown to reduce plaque and gingivitis. 5) New formulations of antimicrobial peptides that target specific oral pathogens.

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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

Select...

I haven't had surgery for gum disease in the last year.

Select...

I have at least 20 natural teeth, not counting wisdom teeth.

Select...

I have moderate to severe gum disease with deep pockets in at least 4 teeth.

Select...

I have at least 20 natural teeth, not counting wisdom teeth.

Select...

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:

Select...

I have severe untreated tooth decay.

Select...

I need medication before any dental work due to a medical condition.

Select...

I have a dental infection that needs treatment during the study.

Select...

I have a disease affecting my mouth's soft or hard tissues.

Select...

I do not have severe systemic diseases or conditions that would prevent proper oral care.

Select...

My gum disease is severe (Stage IV or Grade C).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 6 months

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.

0 / 11Eligibility criteria met

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?