Clinical Investigation of SnF Toothpaste in Reducing Mucositis for Implant Patients

Objectives: Investigated the clinical efficacy of a new toothpaste (Test) containing 0.45% stannous fluoride and stannous pyrophosphate in reducing plaque, mucositis, mucositis bleeding and plaque between the teeth compared to a regular fluoride toothpaste (1000 ppmF, Control).
Methods: The clinical protocol was reviewed and approved by IRB. The study had a randomized, double-blind, parallel-group design. Subjects with initial Mombelli plaque index of at least 1.5 and initial Mombelli mucositis index of at least 1.0 participated in the study. Two Implants were selected on two different quadrants for the study.

At baseline, three and six months, assessments were performed for plaque and mucositis scores around the two implants. For mucositis bleeding score, a sub-group of subjects who started with mucositis index score 2 or 3 at baseline were analyzed. For plaque between the teeth score, a sub-group of subjects whose mesio-facial, disto-facial sites were analyzed.
Results: Eighty subjects enrolled in baseline and seventy-seven subjects completed the 6-month study. At baseline, there were no significant differences between the two groups in plaque, mucositis, mucositis bleeding and plaque between the teeth scores.

At 3 months, the Test group provided statistically significantly 15.3%, 17.3%, 40.4%, and 18.7% greater reductions in plaque, mucositis, mucositis bleeding and plaque between the teeth than the Control group.

At 6 months, the Test group provided statistically significantly 23.6%, 33.8%, 74.4%, and 25.6% greater reductions in plaque, mucositis, mucositis bleeding and plaque between the teeth than the Control group. Specifically, 90% subjects in the Test group showed 50% or more healthy gum sites around implants (mucositis index ≤ 1).
Conclusions: The new toothpaste containing 0.45% SnF showed statistically significantly greater reductions in plaque, mucositis, mucositis bleeding and plaque between the teeth than regular fluoride toothpaste after six months of product use, and helped 90% subjects have 50% or more healthy gum sites around implants.