Gingivitis Oral Health Gingivitis and periodontal diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged = 18 2. Gingivitis diagnosis 3. No detectable oral mucosal lesions 4. Able to complete the present clinical trial
Exclusion criteria
Exclusion criteria: 1. Unable or unwilling to provide informed consent 2. Significant psychiatric or cognitive impairment 3. Pregnant or breast-feeding women 4. Subjects with an history of allergy for ingredients present in PerioTabsTM 5. Subjects with carious teeth 6. Subjects affected by periodontitis or suffering from oral acute conditions requiring antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Gingival inflammation measured using Gingival Index (bleeding on probing) at baseline at 10 days and 36 weeks 2. Plaque formation measured using Plaque Index (PI) at baseline at 10 days and 36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reported adverse events due to the treatment assessed from patient notes at the end of the study 2. Unexpected effects assessed from patient diary records collected at the end of the study | — |
Countries
Italy