About this trial
The goal of this clinical trial is to evaluate the clinical efficacy of an antimicrobial mouthrinse, with a particular focus on its effect on established plaque and the improvement of gum health.
Participants will:
* Brush and rinse twice a day with the designated products for 6 months * Visit the clinic once every 3 months after baseline for reassessment.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male and female subjects aged 18-70 years, inclusive.
Availability for the 6-month duration of the clinical research study.
Good general health based on the opinion of the study investigator.
Signed Informed Consent Form.
Disqualifiers
Be under orthodontic treatment.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Participants with current moderate or severe periodontitis (periodontitis screening index [PSI] >2 in more than 2 sextants or PSI >3), and/or purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone.
Trial design
Parallel
Treatments tested in this trial
Test Mouthrinse
Other interventionTest Mouthrinse: 0.0553% NaF (250 ppm Fluoride), Amine and 0.2% Zinc Lactate dihydrate
Control Mouthrinse
Other interventionControl Mouthrinse: 0.0553% NaF(250 ppm Fluoride)
Treatment groups
Trial outcomes
Primary outcomes
Improvement of gum health as measured by the Gingival Index (Löe 1967) between the study groups.
Four areas of the tooth (buccal, lingual, mesial, and distal surfaces) will be assessed. Each site is assigned a score from 0 to 3 based on clinical observation: 0 indicates normal gingiva and 3 denotes severe inflammation with marked redness, edema, ulceration, and a tendency toward spontaneous bleeding.
Secondary outcomes
Plaque scores as measured by the Plaque Index (Turesky et al. 1970) between the study groups
The index will quantify dental plaque accumulation by assessing the facial and lingual surfaces of all teeth, typically excluding third molars. Using a disclosing solution to make the bacterial biofilm visible, the examiner will assign a score from 0 to 5 to each surface based on the extent of coverage: 0 indicates no plaque and 5 indicates plaque covering more than two-thirds of the tooth surface.
Sponsors and contacts
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