Actively Recruiting
Evaluation of the Effect of the Toothpaste on Delicate Gums
Led by Lacer S.A. · Updated on 2026-05-14
60
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Evaluation of the Effect of the Toothpaste on Delicate Gums
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female subjects
- Caucasian ethnicity
- Aged between 18 and 65 years (inclusive)
- Clinically showing moderate gum inflammation (gingivitis grade II) with mean gingival scores between 1.75 and 2.3
- 40% of subjects with localized gingivitis (10-30% of sites bleeding)
- 60% of subjects with generalized gingivitis (>30% of sites bleeding)
- Dental plaque with total plaque score of at least 2 at inclusion
- Registered with the national health service
- Able to provide truthful personal data
- Able to understand the language used in the study center
- Able to follow instructions and study requirements
- Committed not to change daily routine or lifestyle during the study
- On stable pharmacological therapy for at least one month with no planned changes
- Informed about test procedures and have signed consent and privacy agreements
You will not qualify if you...
- Not meeting the inclusion criteria
- Smokers
- Planning dental treatments during the study
- Using dental apparatus or prosthesis, generalized tooth recession, caries, dental abscess, periodontitis, or active periodontal disease
- Using other dental hygiene products than those provided (e.g., floss, interdental brushes, mouthwash) during study
- Having acute, chronic, or progressive diseases interfering with study or unsafe for participation
- Participating or planning to participate in other clinical trials
- Participated in a similar study without a one-month washout
- Food intolerances or allergies to study product ingredients
- On pharmacological treatments incompatible with study
- Using food supplements or products similar to the study product without a one-month washout
- Admitted to health or social facility
- Planning hospitalization during the study
- Unable to be contacted in emergencies
- Legally deprived of freedom or under guardianship
- History of alcohol or drug addiction
- Eating disorders
- Pregnant, breastfeeding, or unwilling to avoid pregnancy during study (for women of childbearing potential)
AI-Screening
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Trial Site Locations
Total: 1 location
1
CLINICA CIURANA Centre Dental
Castelldefels, Barcelona, Spain, 08860
Actively Recruiting
Research Team
F
Federica Ruggeri
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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