Novel Dental Gel as an Adjunct to Scaling and Root Planing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
• 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.
Trial design
Design model
Parallel
Treatments tested in this trial
SRP + Livfresh Dental Gel
Other interventionSRP 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 dentifrice
Other interventionSRP 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Scaling and Root Planing (SRP) + Livfresh Dental Gel (LDG)Experimental treatment 1 intervention
Group B: Scaling and Root Planing (SRP) + standard fluoride dentifriceActive comparator 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
From baseline to 6 monthsSecondary outcomes
1
Incremental reduction in Gingival Index
Incremental reduction in GI compared to the active control at Day 180 (full mouth) as compared to control
Time frame
From baseline to 6 months2
Incremental reduction in Plaque Index
Incremental reduction in PI compared to the active control at Day 180 (full mouth) as compared to control
Time frame
From baseline to 6 months3
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
Time frame
From baseline to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov