Protocol Efficacy of Mouthwashes in Experimental Gingivitis
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About
This research was performed to find out 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. This is important since Chlorhexidine (CHX) has side effects, like it alters taste sensation, stains the teeth, and contains alcohol compared to the herbal based StellaLife.
Full description
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.
Then, patients will continue the study for an additional period of 2 weeks using only Chlorhexidine mouthwash and placebo gel (without ingredients) without tooth brushing. A new test with OralDNALabs with subsequent periodontal charting will be performed and a prophylaxis visit will be included at the end of the study.
The Group 2 (control)-patients will follow similar protocol starting with use of 0.12% Chlorhexidine (Peridex®) 3x/day as mouthwash for (1-2min) and a placebo control gel (without ingredients) for a period of 2 weeks and then the subjects will start using the StellaLife mouthwash and test gel for 2 weeks (crossover study). Also, the subjects must avoid eating or drinking for 15 min. after the use of the mouthwash and gel.
The GCF will be assessed utilizing the Periotron device at the times of periodontal charting to evaluate changes in volume of GCF (from one and the same site of each participant, one posterior tooth in the maxilla and one in the mandible), comparing the baseline, 2-week, and 4- week (final) visit. The same teeth will be used in all evaluation visits for each individual patient.
The professional cleaning will be performed at the end of the study by a certified dental hygienist to achieve low levels of plaque index and gingival index.
Enrollment
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Inclusion criteria
- healthy patients without periodontal disease
Exclusion criteria
- no pregnant women or patient with immunocompromised systemic diseases
Trial design
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Interventional model
Masking
34 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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