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

Inclusion Criteria11

Male or female subjects at least 18 years of age.
Subject must be willing and able to provide written informed consent.
Available during the course of the study.
Must have minimum of 20 natural teeth, excluding third molars.
Must have at least 20 BOP sites, excluding third molars.
Stage II or III, Grade B periodontitis with at least 4 teeth with a minimum PD of 5 mm and minimum CAL of 3mm.
No antibiotic therapy for periodontal disease or chronic use of anti-inflammatory drugs (NSAIDs) within the past month of Baseline, or during the study.
Must not have received definitive treatment (i.e., SRP or periodontal surgical therapy) for periodontitis in the last one year.
Subject must be willing and able to comply with study visits as described in the protocol.
Subjects must be available for follow up on the telephone.
Able to read and understand the consent form in English

Exclusion Criteria16

• Pregnancy or breast feeding.
Medical condition that requires pre-medication prior to dental procedures.
Systemic conditions and use of medications that may affect periodontal tissues.
Severe dental disease characterized multiple decayed, untreated dental sites.
Presence of orthodontic appliances.
Diseases of oral soft or hard tissues.
Participating in another clinical trial currently or in the month preceding this study.
Stage IV and/or Grade C periodontitis.
Vertical bone defects 4mm or greater.
Subjects who have active dental infections other than periodontitis that will require dental treatment during the study period.
Excessive oral hygiene practices including use of water irrigation devices such as Waterpik or use of interdental cleansers more than twice daily.
Non-English speaking
Smokers, uncontrolled or brittle diabetics, HIV/AIDS, and subjects with severe systemic disease, e.g., cancer, lupus, pemphigus vulgaris/pemphigoid, or other oral mucous membrane diseases that would interfere with performance of oral hygiene, e.g., erosive lichen planus, recurrent major aphthous lesions, etc.
History of allergic reaction to any ingredient in the test/control dentifrices.
Presence of any condition, abnormality, or situation at Baseline that in the opinion of the Principal Investigator may preclude the subject's ability to comply with study requirements, including completion of the study or the quality of the data.
Subjects unwilling to use manual toothbrush during the study.

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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.