Protocol Efficacy of Mouthwashes in Experimental Gingivitis

Objectives: To evaluate the clinical efficacy and the anti-plaque and anti-gingivitis properties of a new oral health product (mouthwash and oral gel; StellaLife) compared to chlorhexidine.

Material and Methods: Two different groups of subjects will be selected for this study. All study participants will have a complete periodontal charting at the initial examination visit (screening visit) and prophylaxis visit. Specifically, periodontal charting with plaque assessment (using disclosing agents), probing measurements (in mm), Gingival Index and gingival crevicular fluid (GCF) analysis (in 2 teeth) will be included.

At the first visit an oral test of the saliva using the OralDNALabs will be used to determine the bacterial load and quality. Then, a professional cleaning and polishing of the teeth will be performed.

The subjects of the Group 1 (test) will use initially a mouth rinse 3x/day with StellaLife (test group) for 1-2 min and one minute test gel (with ingredients) at the gingival margin for 1 min. for a total period of 2 weeks. Toothbrushing and flossing will not be allowed by the subjects. Subjects must avoid eating or drinking for 15 min. after the use of the mouthwash and gel. The gel should be applied for 1 min' to ' apply gel evenly using Q-tip at the neck of the teeth (cervico-gingival junction) on both sides of the teeth.

An oral test of the saliva using the OralDNALabs will be used to determine the bacterial load and quality. Then, a professional cleaning and polishing of the teeth will be performed.