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Periodontal DiseasesNCT05384132

Novel Dental Gel as an Adjunct to Scaling and Root Planing

A study testing SRP + Livfresh Dental Gel and SRP + standard flouride dentifrice in people with Periodontal Diseases and Gingival Diseases, run by University of Alabama at Birmingham at 1 site in United States.

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Sites and contacts
Official record

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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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
What is being tested?
SRP + Livfresh Dental Gel and SRP + standard flouride dentifrice
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteUnited States
Study dates
14 Oct 2022to 30 Oct 2028
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maninder Kaur, BDS,MPH,MS contact

2059344506

maninder@uab.edu

Sarah Startley, DMD contact

2059758711

ss1971@uab.edu

United States1 site, 1 recruiting
  • Unversity of Alabama at Birmingham, School of Dentistry

    Birmingham, Alabama, 35294-0007

    Maninder Kaur, BDS,MPH,MS, 205-934-4506, maninder@uab.edu

    Sarah Startley, DMD, 205-975-8711, ss1971@uab.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed 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.

Being tested
SRP + Livfresh Dental Gel, SRP + standard flouride dentifrice
Medical subject headings
Periodontal Diseases, Gingival Diseases, Gingival Pocket, Gingival Hemorrhage, Dental Plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SRP + Livfresh Dental GelOther

    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 dentifriceOther

    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 groups in NCT05384132
Study groupRoleWhat they receive
Scaling and Root Planing (SRP) + Livfresh Dental Gel (LDG)ExperimentalSRP at Baseline with use of LDG (test dentifrice) for twice daily brushing between study visits.
Receives: Other: SRP + Livfresh Dental Gel
Scaling and Root Planing (SRP) + standard fluoride dentifriceActive comparatorSRP at Baseline with use of standard fluoride dentifrice (control dentifrice) for twice daily brushing between study visits.
Receives: Other: SRP + standard flouride dentifrice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From baseline to 6 months

Secondary outcomes (3)
  1. Incremental reduction in Gingival Index

    Incremental reduction in GI compared to the active control at Day 180 (full mouth) as compared to control

    Measured: From baseline to 6 months

  2. Incremental reduction in Plaque Index

    Incremental reduction in PI compared to the active control at Day 180 (full mouth) as compared to control

    Measured: From baseline to 6 months

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

    Incremental reduction in the number of BOP sites compared to the active control at Day 180 (full mouth) as compared to control

    Measured: From baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2022
  2. Study start14 Oct 2022
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05384132
Sponsor's protocol ID
IRB-300009106
Other IDs
UAB Periodontology
Status last verified
Dec 2025
First submitted
17 May 2022
Last updated
17 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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