Livfresh Dental Gel for Gum Disease

Overseen By Sarah Startley, DMD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Must not be taking: Antibiotics, NSAIDs

Disqualifiers: Pregnancy, Severe dental disease, Smokers, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment LivFresh Dental Gel for gum disease?

One study showed that a gel containing cetylpyridinium chloride and zinc gluconate significantly improved gum health by reducing plaque and gingivitis over six months. This suggests that similar gels, like LivFresh Dental Gel, might also be effective for gum disease. ^{1 2 3 4 5}

Is Livfresh Dental Gel safe for humans?

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 Gel itself is not detailed in the available research. ^{2 6 7 8 9}

How does Livfresh Dental Gel differ from other treatments for gum disease?

Livfresh Dental Gel is unique because it is a mucoadhesive gel designed for overnight application at the gum line and between teeth, containing cetylpyridinium chloride and zinc gluconate, which have shown significant improvements in gum health compared to a control gel. This approach is different from traditional toothpaste or mouthwash treatments, as it specifically targets the areas most affected by gum disease with a specialized formulation. ^{1 2 4 6 10}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Livionex Dental Gel (Behavioural Intervention)

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).

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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 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]

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]

References

1. United States 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. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Plaque Removal and Gingival Health after Use of a Novel Dental Gel: A Clinical Study. [2020]

3. India pubmed.ncbi.nlm.nih.gov

Formulation and evaluation of periodontal in situ gel. [2021]

4. Germany 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial evaluating concurrent gingivitis and stain effects of a two-step dentifrice/gel sequence. [2019]

6. Switzerland 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Clinical effect of a new liquid dentifrice containing triclosan/copolymer on existing plaque and gingivitis. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Moxifloxacin HCl-Incorporated Aqueous-Induced Nitrocellulose-Based In Situ Gel for Periodontal Pocket Delivery. [2023]

9. Egypt pubmed.ncbi.nlm.nih.gov

Effects of a Novel Formulation on Oral Biofilm, pH Buffering, and Gingival Health in Patients with Dry Mouth. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Tau-Marin Mucoadhesive Gel for Prevention and Treatment of Gum Diseases. [2023]