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New treatment option for Periodontal Diseases
Official title Novel Dental Gel as an Adjunct to Scaling and Root Planing
ClinicalTrials.gov ID: NCT05384132
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Male or female people 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.
You likely can't join 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.
See the full eligibility criteria
- Male or female people 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.
- people must be available for follow up on the telephone.
- Able to read and understand the consent form in English
- 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.
- people 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 people with severe systemic disease, e.g., cancer, lupus, pemphigus vulgaris/pemphigoid, or other oral mucous membrane diseases that would interfere with...
- 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...
- people unwilling to use manual toothbrush during the study.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.