Livfresh Dental Gel for Gum Disease

Overseen By Sarah Startley, DMD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Antibiotics, NSAIDs

Disqualifiers: Pregnancy, Severe dental disease, Smokers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of Livfresh Dental Gel (also known as Livionex Dental Gel) in improving gum health in individuals with gum disease, or periodontitis. It specifically compares the gel to regular fluoride toothpaste when used alongside standard dental cleaning methods, such as scaling and root planing (SRP). Individuals with gum disease who have not undergone major dental treatments in the past year and have at least four problem teeth may qualify. As an unphased trial, this study provides an opportunity to contribute to significant research on enhancing dental health.

Will I have to stop taking my current medications?

The trial requires that you have not used antibiotics for gum disease or regularly used anti-inflammatory drugs (like NSAIDs) in the past month and during the study. If you are on these medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Livionex Dental Gel is generally safe to use. One study compared this gel to regular toothpaste, and participants used it without any problems, although specific safety details weren't provided. The gel contains ingredients safe for consumption and lacks harsh chemicals like sulfates and abrasives, which can cause irritation, making it gentle on the gums.

Additionally, experts consider the gel Generally Recognized As Safe (GRAS), indicating its safety for use. It is also free from gluten, sugar, and other common irritants. Overall, Livionex Dental Gel appears well-tolerated by users, with no major side effects reported in the available studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Livfresh Dental Gel is unique because it offers a new approach to tackling gum disease by incorporating a patented formulation that disrupts the biofilm on teeth more effectively than standard fluoride toothpaste. Most treatments for gum disease focus on controlling plaque through mechanical removal and fluoride's protective effects. However, Livfresh Dental Gel targets the bacterial biofilm that causes gum inflammation, offering a potentially more efficient way to manage gum disease and improve oral health. Researchers are excited about this gel because it promises enhanced cleaning action, potentially leading to better outcomes in maintaining gum health compared to traditional fluoride-based products.

What evidence suggests that Livfresh Dental Gel could be effective for gum disease?

Research has shown that Livionex Dental Gel, which participants in this trial may receive, can greatly improve gum health. In one study, over 80% of areas with gum disease improved when people used this gel. Another study found that the gel reduced gum swelling, bleeding, and the depth of gum pockets more effectively than regular toothpaste. Users also experienced a significant decrease in plaque, with improvements over 250%, and gum bleeding improvements over 232%. These results suggest that Livionex Dental Gel could be a strong choice for improving gum health. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject must be willing and able to provide written informed consent

You have at least 20 BOP sites.

Must have at least 20 BOP sites, excluding third molars

Exclusion Criteria

Pregnancy or breast feeding

I have severe untreated tooth decay.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Scaling and Root Planing (SRP) at Baseline and use either Livfresh Dental Gel or standard fluoride dentifrice for twice daily brushing

6 months

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Livionex Dental Gel

Trial Overview 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).

How Is the Trial Designed?

Group I: Scaling and Root Planing (SRP) + Livfresh Dental Gel (LDG) Experimental Treatment 1 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 dentifrice Active Control 1 Intervention

SRP at Baseline with use of standard fluoride dentifrice (control dentifrice) for twice daily brushing between study visits.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

The novel activated edathamil dental gel significantly reduced plaque levels by 45% compared to the Triclosan/copolymer dentifrice over 4 weeks, indicating superior plaque control.

The test gel also led to a significant reduction in gingival inflammation compared to the control, suggesting it effectively supports gum health without using abrasives or antimicrobials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plaque Removal and Gingival Health after Use of a Novel Dental Gel: A Clinical Study. Nayudu, A., Lam, T., Ho, J., et al.[2020]

A controlled clinical trial demonstrated that a mucoadhesive gel containing 0.10% cetylpyridinium chloride (CPC) and 0.592% zinc gluconate (ZG) significantly improved gingival health in adults over 3 and 6 months compared to a control gel.

The CPC/ZG gel not only showed clinical improvements in gingival and plaque indices but was also supported by microbial analyses, indicating its efficacy in reducing harmful bacteria associated with gum disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiplaque/antigingivitis efficacy and safety of a cetylpyridinium chloride/zinc gluconate mucoadhesive gel. Results of a 6-month clinical trial. Lee, SS., Aprecio, RM., Zhang, W., et al.[2013]

In a study involving ten subjects with dry mouth, both the novel Oral Essentials Hydrating Formula Mouthwash and the control Biotène Dry Mouth Oral Rinse showed similar effectiveness in reducing plaque and improving gingival health.

Both mouthwash products significantly increased saliva volume and pH buffering capacity compared to no treatment, indicating that they are effective interventions for managing dry mouth symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Novel Formulation on Oral Biofilm, pH Buffering, and Gingival Health in Patients with Dry Mouth. Takesh, T., Ho, J., Firmalino, MV., et al.[2022]

A randomized clinical trial involving 22 patients with desquamative gingivitis showed that a gel containing propolis extract, nanovitamin C, and nanovitamin E can improve clinical outcomes and quality of life without any reported side effects.

While both the test and control groups experienced a decrease in desquamative gingivitis clinical scores and pain levels, the test group demonstrated statistically significant improvements in periodontal variables and quality of life measures after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a bioadhesive gel containing propolis extract, nanovitamin C and nanovitamin E on desquamative gingivitis: a double-blind, randomized, clinical trial. González-Serrano, J., Serrano, J., Sanz, M., et al.[2023]

The study developed an in situ forming gel (ISG) using Eudragit L and levofloxacin HCl, which showed favorable properties for treating periodontitis, including appropriate viscosity and injectability, making it easy to administer directly into the periodontal pocket.

The formulation with 1% levofloxacin HCl and 15% Eudragit L demonstrated prolonged drug release over 14 days and effective antimicrobial activity against various bacteria and fungi, indicating its potential as a localized treatment for periodontitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levofloxacin HCl-Loaded Eudragit L-Based Solvent Exchange-Induced In Situ Forming Gel Using Monopropylene Glycol as a Solvent for Periodontitis Treatment. Senarat, S., Tuntarawongsa, S., Lertsuphotvanit, N., et al.[2023]

The study developed a novel moxifloxacin HCl (Mx)-incorporated in situ forming gel (ISG) using nitrocellulose (Nc) as a polymer, which effectively prolonged drug release for up to two weeks and demonstrated strong antibacterial activity against periodontitis pathogens.

The ISGs showed favorable properties such as low viscosity and ease of injection, transforming into a gel upon contact with water, making them promising for localized treatment; however, further clinical trials are needed to assess their safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moxifloxacin HCl-Incorporated Aqueous-Induced Nitrocellulose-Based In Situ Gel for Periodontal Pocket Delivery. Senarat, S., Rojviriya, C., Sarunyakasitrin, K., et al.[2023]

In a randomized controlled trial involving 61 healthy adults, a two-step oral hygiene regimen using 0.454% SnF₂ dentifrice followed by 3% H₂O₂ whitening gel significantly reduced gingivitis and extrinsic stains compared to a regular dentifrice after just one week.

The two-step treatment showed substantial improvements in both the Gingivitis Bleeding Index and the Lobene Stain Index, indicating its efficacy in enhancing oral health and aesthetics, while being well-tolerated by participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial evaluating concurrent gingivitis and stain effects of a two-step dentifrice/gel sequence. Amini, P., Amini, A., Gerlach, RW.[2019]

The probiotic-containing mucoadhesive gel (AL0020) was developed to address dysbiosis in periodontal diseases and showed effective release of probiotics over an 8-hour period in both physiological and simulated saliva conditions.

In a clinical trial with 20 volunteers over 30 days, AL0020 demonstrated efficacy in controlling gum disorders, indicating its potential as a therapeutic option for periodontal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tau-Marin Mucoadhesive Gel for Prevention and Treatment of Gum Diseases. Giannini, G., Ragusa, I., Nardone, GN., et al.[2023]

A six-month clinical study showed that a fluoridated liquid dentifrice with triclosan and a PVM/MA copolymer significantly reduced plaque by 34.9% and gingivitis by 25.7% compared to a placebo, indicating its efficacy in oral health.

The experimental liquid dentifrice's effectiveness in reducing plaque and gingivitis is comparable to traditional paste dentifrices with similar active ingredients, suggesting it is a viable alternative for dental care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effect of a new liquid dentifrice containing triclosan/copolymer on existing plaque and gingivitis. Triratana, T., Rustogi, KN., Volpe, AR., et al.[2019]

A temperature-sensitive in situ gel containing 0.1% Chlorhexidine hydrochloride was successfully developed, showing sustained drug release for up to 6 hours, making it a promising treatment for periodontal disease.

The optimized formulation (F6) demonstrated favorable characteristics such as clarity, appropriate pH, and effective drug release, indicating its potential efficacy in delivering the medication effectively to treat gum disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formulation and evaluation of periodontal in situ gel. Garala, K., Joshi, P., Shah, M., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8033283/

New US toothpaste significantly improves gum health - PMC In individuals who brushed with the test gel, pocket depths in the gums improved in more than 80% of diseased sites. Additionally, subjects who brushed with the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6938303/

Effects of a Dental Gel Over 6 Months on Periodontal Health in ... A test dental gel more effectively reduced gingival inflammation and bleeding, as well as periodontal pocket probing depths than a control dentifrice.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05384132

Novel Dental Gel as an Adjunct to Scaling and Root Planing Recent studies have shown a dental gel with activated edathamil (2.6 % Livionex) has demonstrated reduced plaque accumulation and improved gingival health ...

4. getlivfresh.com getlivfresh.com/pages/research-studies?srsltid=AfmBOoq7d7ocymVRCG5-4_VUB5oFlTk6bd-8Mh_ysthIV0CjzL992u8j

Dental Gel Research Studies LIVFRESH users improved plaque levels by more than 250%, gingival inflammation improved by more than 229%, and gum bleeding improved by more than 232%.

5. digitalcommons.library.uab.edu digitalcommons.library.uab.edu/cgi/viewcontent.cgi?article=1396&context=etd-collection

Randomized Control Trial of a Novel Dental Gel as an Adjunct ... This study hypothesizes that the adjunctive use of Livionex Dental Gel (LDG) as a home care product result in the reduction of probing pocket depth (PD) beyond ...

6. amazon.com amazon.com/LIVFRESH-Dental-Gel-Livionex-Wintergreen/dp/B07PQYJBM3

LIVFRESH Toothpaste Gel, Clinically Proven to Remove ... SAFE FOR ALL AGES - Proudly made in America, LIVFRESH uses 100% edible ingredients and is SLS-Free. Our gel toothpaste contains zero abrasives, sulfates, ...

7. withpower.com withpower.com/trial/phase-gingival-diseases-6-2022-08d86

Livfresh Dental Gel for Gum Disease A clinical study compared a novel dental gel to a standard toothpaste and found it was used safely by participants, but specific safety data for Livfresh Dental ...

8. getlivfresh.com getlivfresh.com/?srsltid=AfmBOop2K2xUNnTKJGOgD_SSWMomECZ50uOLhCG7Ut6-yXoRYL5F8QM_

LIVFRESH Dental Gel | Best Dental Plaque Removal Toothpaste GRAS stands for Generally Recognized As Safe. LivFresh does not contain any gluten, sugar, parabens, phthalates, abrasives, antimicrobials, SLS, or Triclosan.