Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Active Comparator | Subjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds. |
|
| Control Group | Placebo Comparator | subjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Mouthrinse | Other | Test Mouthrinse: 0.0553% NaF (250 ppm Fluoride), Amine and 0.2% Zinc Lactate dihydrate |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6-month period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eva-Maria Axmann | SGS proderm GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS proderm GmbH | Recruiting | Schenefeld | 22869 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
| Control Mouthrinse | Other | Control Mouthrinse: 0.0553% NaF(250 ppm Fluoride) |
|
| 6-month period |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided