Clinical research study to evaluate the effect on gingival inflammation of a toothpaste containing vitamin D in patients with established dental plaque and gingivitis.

INTERVENTION: All test subjects will be provided with soft‐bristled adult toothbrushes, and tubes of commercially available fluoride toothpastes with 0.01% vitamin D3 for the duration of study, 60 days. They will be instructed to brush their teeth for two minutes twice daily (in the morning and evening) with the toothpaste provided (a pea size amount, i.e. approx.. 0.25‐0.50g of toothpaste at a time). At 20 days, the subjects will be asked to return any reamining toothpaste and new toothpastes with the vitamin D3 will be replenished until the following appointment, 60 days. CONDITION: Gingivitis; ; Gingivitis Oral and Gastrointestinal ‐ Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon PRIMARY OUTCOME: Gingival index changes[Baseline, 20 and 60 days (Primary endpoint)] Inflammatory cytokine level changes (IL‐1a, b, TNF‐a, IL‐10, MCP‐1, MIP‐1, MIP‐2, IL‐6, Il‐13) in gingival crevicular fluids (GCFs) ‐ Exploratory outcome[Baseline, 20 and 60 days (Primary endpoint)] Plaque Index chnages[Baseline, 20 and 60 days (Primary endpoint)] SECONDARY OUTCOME: Inflammatory cytokine (IL‐1a, b, TNF‐a, IL‐10, MCP‐1, MIP‐1, MIP‐2, IL‐6, Il‐13) level changes in Saliva ‐ Exploratory outcome[Baseline, 20 and 60 days (Primary endpoint)] Serum Vit D level changes in blood[Baseline and 60 days] INCLUSION CRITERIA: 1. Males and females, between 18‐70 years of age; 2. Availability for the duration of the study; 3. Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc); 4. Willingness to provide information related to their medical history; 5. Minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns); 6. Initial gingivitis index average score of 1.5 as determined by the use of the Loe and Silness Gingival Index, more than 30% of bleeding sites and absence of periodontal disease; 7. Informed Consent Form signed.