Using a new dental gel to improve gum health after cleaning

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 is testing if a new dental gel can help people with gum disease get even better results after their teeth cleaning treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: University of Alabama at Birmingham (other)
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT05384132 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of Livionex Dental Gel (LDG) as a home care product to enhance the results of scaling and root planing (SRP) in patients with periodontitis. SRP is a standard dental procedure aimed at removing plaque and tartar from teeth to alleviate gum disease. The study aims to determine if the addition of LDG can further reduce probing pocket depth beyond what is achieved with SRP alone. Participants will be monitored for their oral health and adherence to the treatment protocol throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with stage II or III, Grade B periodontitis and specific periodontal conditions.

Not a fit: Patients who are pregnant, breastfeeding, or have received recent periodontal treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved gum health and reduced periodontal disease progression for patients.

How similar studies have performed: Other studies have shown promise in using adjunctive therapies for periodontal treatment, but the specific use of LDG is novel.

Eligibility criteria

Inclusion Criteria:

* 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.
  * 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

Exclusion Criteria:

* • 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.
  * 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.

Where this trial is running

Birmingham, Alabama

• Unversity of Alabama at Birmingham, School of Dentistry — Birmingham, Alabama, United States (RECRUITING)

Study contacts

• Study coordinator: Maninder Kaur, BDS,MPH,MS

Conditions: Periodontal Diseases, Gingival Diseases, Gingival Pocket, Gum Bleed, Plaque, Dental