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.
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
- Conditions the study is for
- Periodontal Diseases, Gingival Diseases, Gingival Pocket
- 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
- Are there results?
- Not yet: the study is under way
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.
United States1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: SRP + standard flouride dentifrice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted20 May 2022
- Study start14 Oct 2022
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maninder Kaur, University of Alabama at Birmingham
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05384132
- Acronym / sponsor ID
- IRB-300009106
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scaling and Root Planing (SRP) + Livfresh Dental Gel (LDG) | Experimental | Other: SRP + Livfresh Dental GelSRP at Baseline with use of LDG (test dentifrice) for twice daily brushing between study visits. |
| Scaling and Root Planing (SRP) + standard fluoride dentifrice | Active comparator | Other: SRP + standard flouride dentifriceSRP at Baseline with use of standard fluoride dentifrice (control dentifrice) for twice daily brushing between study visits. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects at least 18 years of age.
Key exclusion criteria (16 listed)
- • Pregnancy or breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRP + Livfresh Dental GelSRP 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. | Other | Scaling and Root Planing (SRP) + Livfresh Dental Gel (LDG) |
| SRP + standard flouride dentifriceSRP 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. | Other | Scaling and Root Planing (SRP) + standard fluoride dentifrice |
Primary outcome
Incremental reduction in gingival pocket depth.
Time frame: From baseline to 6 months
Incremental reduction in PD compared to the active control at Day 180 for those sites with PD > 4 mm as compared to control.
3 secondary outcomes
Incremental reduction in Gingival Index
Time frame: From baseline to 6 months
Incremental reduction in Plaque Index
Time frame: From baseline to 6 months
Incremental reduction in the number of Bleeding on Probing (BOP)
Time frame: From baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maninder Kaur, BDS,MPH,MS (2059344506, maninder@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental reduction in gingival pocket depth. (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.