Novel Dental Gel as an Adjunct to Scaling and Root Planing

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05384132
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Oct 14, 2022
Status verified
Dec 2025
Primary completion
Oct 30, 2027
Completion
Oct 30, 2028

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Scaling and Root Planing (SRP) + Livfresh Dental Gel (LDG)
    SRP at Baseline with use of LDG (test dentifrice) for twice daily brushing between study visits.
  • Active Comparator: Scaling and Root Planing (SRP) + standard fluoride dentifrice
    SRP at Baseline with use of standard fluoride dentifrice (control dentifrice) for twice daily brushing between study visits.

Primary Outcome Measure

Incremental reduction in gingival pocket depth. [ Time Frame: From baseline to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Unversity of Alabama at Birmingham, School of DentistryBirminghamAlabama35294-0007
Maninder Kaur, BDS,MPH,MS
[email protected]
205-934-4506
Sarah Startley, DMD
[email protected]
205-975-8711

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By research site
Unversity of Alabama at Birmingham, School of Dentistry· Birmingham, AL

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