Benchmark Controlled Evaluation of the Effect of a Cosmetic Product in Improving Gums Condition - in Use Test Under Dentist Control
Phase: NA
Conditions: Gingivitis
Sponsor: Lacer S.A.

 
 
 
Benchmark controlled evaluation of the effect of a cosmetic product in 
improving gums condition – in use test under dentist control 
Protocol ID: PIT0000334/25 
Date: 03Mar2026 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study synopsis 
 
The study objective is to assess the eﬃcacy of a cosmetic product (toothpaste) 
in improving the signs of gingivitis maintaining in comparison to regular 
toothpaste.  
In order to reach this goal, a double-blind, randomized, parallel-group, placebo-
controlled clinical study is planned to be performed on 60 (66 enrolled) healthy 
female and male subjects more than 18 years old, with grade II gingivitis enrolled 
according to the speciﬁc inclusion and non-inclusion criteria. The subjects will 
use the assigned product (experimental or regular toothpaste according to the 
randomization list) 2-3 times a day for 28 days. The eﬃcacy will be evaluated by 
changes in gingival index, plaque index and bleeding on probing carried out 
before and after 24 hours, 48 hours, 7 days and 28 days of product use. The 
subjects will also give their opinion about subjective perception of the eﬃcacy by 
means of questionnaire. The occurrence of adverse events will be also recorded. 
The study was approved by an independent ethics committee, and no protocol 
amendments were done after the approval and up to date.