Novel Dental Gel as an Adjunct to Scaling and Root Planing

Periodontal Diseases Clinical Trial

Official title: Randomized Control Trial of a Novel Dental Gel as an Adjunct to Scaling and Root Planing in Subjects With Stage II and III Periodontitis

Status Recruiting

Clinical Trial Summary

This study will evaluate the use of Livionex Dental Gel (LDG) as a home care product in reducing probing pocket depth (PD) beyond the effect achieved by the current standard of care with SRP in periodontitis patients.

Clinical Trial Description

The current standard of care in treating periodontitis is scaling and root planing (ScRP). ScRP is the instrumentation of the crown and root surfaces of teeth to remove plaque, tartar, and stains, as well as, the removal of cementum or surface dentin that is rough, impregnated with calculus or contaminated with toxins and/or microorganisms. This procedure is performed because the patient is at the stage of their disease where the bacterial load has accumulated subgingival and their toothbrush or interdental devices is no longer efficacious. As the etiology of the disease is removed, it relieves the biological burden and allows the body to resolve the inflammation. To prevent re-initiation of the disease, oral hygiene and periodontal maintenance therapy is key to periodontal health and stability. Formation of plaque begins with the formation of a pellicle which occurs within seconds after a tooth surface is cleaned. Within minutes, weak adhesion of bacteria to pellicle is formed. If bacteria is not removed or disturbed within 24-48 hours, primary colonizers such as Streptococcus and Actinomyces sp are firmly attached and provide new receptors for attachment of other bacteria. Toothbrushing twice daily and interdental cleaning daily limits the ability for over accumulation of biomass thus preventing the initiation of chronic inflammatory process.

The benefits of optimal at-home plaque control have greatly contributed to maintaining a functional dentition throughout life, decrease risk of attachment loss, benefits in appearance and breath freshness, and prevention in expensive dental care. Despite this knowledge, 69% American adults brush their teeth twice daily and only 31.6% of Americans adults use interdental devices. And of those who do perform mechanical debridement their efficacy in plaque removal is in question. Not to mention, the elderly with cognitive and physical conditions which may inhibit adequate oral hygiene practices such as advanced dementia and severe arthritis. Studies have demonstrated high prevalence rates of caries, poor oral hygiene, gingival inflammation, dry mouth, bleeding gums, and periodontal disease among nursing home elders. Because of this, the quest to attain plaque control more easily has been researched through better toothbrush designs and new dentrifice formulations. Over the counter dentifrice formulations typically include flavorings, chelators, colors, preservatives, foaming agents, abrasives, and detergents. Some of these common ingredients have the potential to be too abrasive and remove tooth structure, cause sensitivity or allergic reactions, and some have been reported to spread in the blood and different organ systems. Without knowing the long-term effects of these findings, manufacturers are avoiding some of these ingredients. Recent studies have shown a dental gel with activated edathamil (2.6 % Livionex) has demonstrated reduced plaque accumulation and improved gingival health while minimizing the side effects experienced with over-the-counter dentifrices. Its anti-plaque ability is explained by its capability to bind to cations such as calcium and iron which are essential for bacterial adherence to tooth structures. A dental gel that is attainable for the public and have the capabilities of minimizing plaque accumulation shows promise to individuals that struggle with plaque control and recurrence of periodontal disease.

The overall aim of this randomized, double-blind, active-control safety and efficacy study will be to evaluate the adjunctive therapeutic effect of using LDG as a home care product in reducing probing pocket depth (PD) beyond the effect achieved by the current standard of care with SRP in stage II and III periodontitis patients. ;

Related Conditions & MeSH terms

• Dental Plaque
• Gingival Diseases
• Gingival Pocket
• Gum Bleed
• Periodontal Diseases
• Plaque, Dental

• NCT number: NCT05384132
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Contact: Maninder Kaur, BDS,MPH,MS
• Phone: 2059344506
• Email: maninder@uab.edu
• Status: Recruiting
• Phase: N/A
• Start date: October 14, 2022
• Completion date: October 2025