Evaluation of the Effect of the Toothpaste on Delicate Gums
ConditionGingivitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLacer S.A.
About this trial
The goal of this study is to learn if a toothpaste works to alleviate gingivitis in adults. It will also learn about the safety of the product. The main question it aims to answer is:
• Does the toothpaste help to improve signs of gingivitis? Researchers will compare gingivitis toothpaste to a regular toothpaste to see if it works to improve gingivitis.
Participants will:
* Use assigned toothpaste daily for 4 weeks * Visit the clinic on the established days during 4 weeks for check-ups and evaluation
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Healthy male and female subjects (with no specific repartition)
Subjects of Caucasian ethnicity
Subjects aged between 18 and 65 years (extremes included)
40% of the subjects with localized gingivitis (10-30% of evaluated sites with bleeding)
Disqualifiers
Subjects who do not meet the inclusion criteria
Smokers subjects
Subjects planning toothcare during the study period
Subjects using dental apparatus or using dental prosthesis, with generalized tooth recession, with presence of caries, with dental abscess or signs of periodontitis (periodontal probing depth >3mm) or active periodontitis
Trial design
Design model
Parallel
Treatments tested in this trial
Gingivitis toothpaste
Other interventionSubjects will use the gingivitis toothpaste 2-3 times daily during 4 weeks
Regular toothpaste
Other interventionSubjects will use the regular toothpaste 2-3 times daily during 4 weeks
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Gingivitis tooothpasteExperimental treatment 1 intervention
Group B: Regular toothpasteActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in the Gingival Index at 1 month
Time frame
From baseline to end of treatment at 1 monthSecondary outcomes
1
Change in plaque index at 1 month
Time frame
From baseline to end of use at 1 month Source ClinicalTrials.gov