Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bleeding Gum
  • Gingivitis
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 50 subjects affected with gingivitis, caused by accumulation of plaque and/or tartar, will be selected and enrolled in this study. Subsequently, subjects will be equally divided and randomly allocated to either the test group or the control group.Masking: Double (Participant, Investigator)Masking Description: The products will be packaged in such a way that they are not recognizable neither by the operator, nor by the patient. Each package will be assigned a number that in turn will refer to the type of the product. The association between the number and type of the product will be collected by another operator according to the association carried out by a dedicated software. The operator who will deliver the product will be informed about the type only at the end of the treatment.Primary Purpose: Treatment

Participation Requirements

Age
Between 12 years and 50 years
Gender
Both males and females

Description

50 subjects will be enrolled, who show with gingivitis caused by accumulation of plaque and/or tartar selected consecutively. Subsequently, subjects will be equally divided and randomized into the test group or control group. During the three examinations, the subjects will undergo the collection of...

50 subjects will be enrolled, who show with gingivitis caused by accumulation of plaque and/or tartar selected consecutively. Subsequently, subjects will be equally divided and randomized into the test group or control group. During the three examinations, the subjects will undergo the collection of bleeding and plaque indices according to Silness J & Loe H 3,4. Four surfaces per tooth (vestibular, lingual/palatal, mesial, distal) will be considered.

Tracking Information

NCT #
NCT04438421
Collaborators
Not Provided
Investigators
Principal Investigator: Giampietro Farronato, Professor University of Milan Principal Investigator: Gianguido Cossellu, Fellow University of Milan