Novel Dental Gel as an Adjunct to Scaling and Root Planing

NCT05384132 | Recruiting

• 2 other identifiers: IRB-300009106UAB Periodontology
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Incremental reduction in gingival pocket depth.

  Incremental reduction in PD compared to the active control at Day 180 for those sites with PD \> 4 mm as compared to control.

  From baseline to 6 months

Secondary Outcomes (3)

• Incremental reduction in Gingival Index

  From baseline to 6 months

• Incremental reduction in Plaque Index

  From baseline to 6 months

• Incremental reduction in the number of Bleeding on Probing (BOP)

  From baseline to 6 months

Study Arms (2)

Scaling and Root Planing (SRP) + Livfresh Dental Gel (LDG)

EXPERIMENTAL

SRP at Baseline with use of LDG (test dentifrice) for twice daily brushing between study visits.

Other: SRP + Livfresh Dental Gel

Scaling and Root Planing (SRP) + standard fluoride dentifrice

ACTIVE COMPARATOR

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

Other: SRP + standard flouride dentifrice

Interventions

SRP + standard flouride dentifrice OTHER

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.

Scaling and Root Planing (SRP) + standard fluoride dentifrice

SRP + Livfresh Dental Gel OTHER

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.

Scaling and Root Planing (SRP) + Livfresh Dental Gel (LDG)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Unversity of Alabama at Birmingham, School of Dentistry

Birmingham, Alabama, 35294-0007, United States

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Gingival Diseases; Gingival Pocket; Gingival Hemorrhage; Dental Plaque

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gingivitis; Infections; Oral Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dental Deposits; Tooth Diseases

Central Study Contacts

Maninder Kaur, BDS,MPH,MS

CONTACT

2059344506; maninder@uab.edu

Sarah Startley, DMD

CONTACT

2059758711; ss1971@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: October 14, 2022
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)