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Livfresh Dental Gel for Gum Disease

N/A
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects at least 18 years of age
Must not have received definitive treatment (i.e., SRP or periodontal surgical therapy) for periodontitis in the last one year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 6 months
Awards & highlights

Study Summary

This trial will study whether Livionex Dental Gel, used at home, can reduce pocket depth beyond what is achievable with the current standard of care (scaling and root planing).

Who is the study for?
Adults over 18 with Stage II or III, Grade B gum disease, at least 20 natural teeth (excluding wisdom teeth), and no recent periodontal treatments or antibiotic/anti-inflammatory use. Participants must not be pregnant, breastfeeding, smokers, have severe systemic diseases like cancer or uncontrolled diabetes, nor be using certain dental products excessively.Check my eligibility
What is being tested?
The trial is testing if a novel dental gel called Livionex Dental Gel (LDG) used at home can improve gum health more than the standard fluoride toothpaste when both are added to professional cleaning treatments known as Scaling and Root Planing (SRP).See study design
What are the potential side effects?
While specific side effects of LDG aren't listed in this summary, typical side effects from dental gels may include mouth irritation or allergic reactions to ingredients. It's important for participants to report any unusual oral discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I haven't had surgery for gum disease in the last year.
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I have at least 20 natural teeth, not counting wisdom teeth.
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I am 18 years old or older.
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I have moderate to severe gum disease with deep pockets in at least 4 teeth.
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I have at least 20 natural teeth, not counting wisdom teeth.
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I have moderate to severe gum disease with deep pockets in at least 4 teeth.
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I haven't taken antibiotics for gum disease or used anti-inflammatory drugs regularly in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incremental reduction in gingival pocket depth.
Secondary outcome measures
Incremental reduction in Gingival Index
Incremental reduction in Plaque Index
Incremental reduction in the number of Bleeding on Probing (BOP)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Scaling and Root Planing (SRP) + Livfresh Dental Gel (LDG)Experimental Treatment1 Intervention
SRP at Baseline with use of LDG (test dentifrice) for twice daily brushing between study visits.
Group II: Scaling and Root Planing (SRP) + standard fluoride dentifriceActive Control1 Intervention
SRP at Baseline with use of standard fluoride dentifrice (control dentifrice) for twice daily brushing between study visits.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,269,335 Total Patients Enrolled

Media Library

SRP + Livfresh Dental Gel Clinical Trial Eligibility Overview. Trial Name: NCT05384132 — N/A
Gum Disease Research Study Groups: Scaling and Root Planing (SRP) + Livfresh Dental Gel (LDG), Scaling and Root Planing (SRP) + standard fluoride dentifrice
Gum Disease Clinical Trial 2023: SRP + Livfresh Dental Gel Highlights & Side Effects. Trial Name: NCT05384132 — N/A
SRP + Livfresh Dental Gel 2023 Treatment Timeline for Medical Study. Trial Name: NCT05384132 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial welcoming elderly participants?

"This research is open to any participants under 85 years old and above the age of legal majority."

Answered by AI

What is the estimated sample size for this research endeavor?

"Yes, the information on clinicaltrials.gov reveals that this trial is actively searching for enrollees. It was initially launched on October 14th 2022 and its most recent update was made on October 31st 2022. 76 participants are required from a single medical site."

Answered by AI

Does this trial still accept new enrollees?

"Affirmative. Clinicaltrials.gov data confirms that this research project, which was originally publicized on October 14th 2022, is still calling for recruits. Approximately 76 patients need to be recruited from 1 medical centre."

Answered by AI

To whom does eligibility requirements for this experiment apply?

"This trial is seeking 76 male or female participants aged 18 to 85 with dental plaque. To be eligible, candidates must have a minimum of 20 teeth, excluding third molars, and evidence of periodontitis (Stage II or III Grade B) on at least 4 of them. Additionally they are required to provide written consent and not use antibiotics for periodontal disease nor chronic anti-inflammatory drugs in the month before Baseline or during the study duration. Furthermore subjects need to commit to comply with all follow up visits as described by protocol and be available for telephone contact throughout the study course."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Unversity of Alabama at Birmingham, School of Dentistry
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~20 spots leftby Oct 2024