RecruitingNot ApplicableNCT05384132

Novel Dental Gel as an Adjunct to Scaling and Root Planing

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

Sponsor

University of Alabama at Birmingham

Enrollment

76 participants

Start Date

Oct 14, 2022

Study Type

INTERVENTIONAL

Conditions

Plaque, Dental Periodontal Diseases Gingival Diseases Gingival Pocket Gum Bleed

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a novel dental gel to a standard dental cleaning procedure (scaling and root planing) helps treat moderate to severe periodontitis (gum disease) better than the cleaning alone. Periodontitis is a serious gum infection that damages the soft tissue and bone supporting the teeth and, if untreated, can lead to tooth loss. You may be eligible if: - You are 18 or older, male or female - You have at least 20 natural teeth (excluding wisdom teeth) - You have Stage II or Stage III periodontitis with at least 4 teeth with pocket depths of 5 mm or more - You have not received professional gum treatment (scaling and root planing or surgery) in the past year - You have not taken antibiotics or anti-inflammatory drugs for periodontal disease in the past month You may NOT be eligible if: - You are pregnant or breastfeeding - You have a medical condition requiring pre-medication before dental procedures - You have systemic conditions (e.g., cancer, lupus, HIV/AIDS) or take medications that affect gum tissue - You are a smoker, or have uncontrolled diabetes - You have Stage IV or Grade C periodontitis, or very deep vertical bone defects (4 mm or greater) - You are participating in another clinical trial - You speak only a language other than English Talk to your doctor or dentist to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERSRP + Livfresh Dental Gel

SRP at baseline with use of LDG (test dentifrice) for twice daily brushing between study visits. Scaling and root planing is the physical removal of dental plaque, calculus, and bacterial exotoxins embedded onto the root surface of effected teeth with hand instruments and ultrasonic devices. In addition to scaling and root planing, the participants will use LDG as their primary dentrifice (toothpaste) for the next 6 months. They're instructed to use LDG twice daily with toothbrushing for 2 minutes. LDG in previous studies have been reported to be superior to conventional over-the-counter toothpaste in terms of reducing bacterial plaque and gingival inflammation due to its EDTA (ethylenediaminetetraacetic acid) ingredient. EDTA prevents adhesion of bacterial plaque to teeth.

OTHERSRP + standard flouride dentifrice

SRP at baseline with use of standard fluoride dentifrice (control dentifrice) for twice daily brushing between study visits. Scaling and root planing is the physical removal of dental plaque, calculus, and bacterial exotoxins embedded onto the root surface of effected teeth with hand instruments and ultrasonic devices. In addition to scaling and root planing, the participants will use standard fluoride toothpaste (commercial over-the-counter toothpaste) as their primary dentrifice (toothpaste). They're instructed to use standard fluoride toothpaste twice daily with toothbrushing for 2 minutes.