Evaluation of the Effect of the Mouthwash on Delicate Gums
ConditionGingivitis
Trial statusNot yet recruiting
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 mouthwash 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 mouthwash help to improve signs of gingivitis?
Participants will:
* Use mouthwash daily for 4 weeks * Visit the clinic on the established days during 4 weeks for check-ups and evaluation
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy male and female subjects (with no specific repartition)
Subjects of Caucasian ethnicity
Subjects aged between 18 and 65 years (extremes included)
20% 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
Single group
Treatments tested in this trial
Mouthwash for delicate gums
Other interventionMouthwash will be used 3 times a day after brushing during 4 weeks.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: mouthwashExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Gingival Index Score at 4 weeks
The score is from 0 (normal gum) to 4 (severe inflammation, swelling, bleeding and presence of ulcers).
Time frame
From enrolment to the end of use at 4 weeks.Locations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: