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New treatment option for Gingivitis
Official title Evaluation of the Effect of the Toothpaste on Delicate Gums
ClinicalTrials.gov ID: NCT07494747
What this study is testing
- What it's testing
- 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.
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Healthy male and female people (with no specific repartition)
- people of Caucasian ethnicity
- people aged between 18 and 65 years (extremes included)
- people clinically showing moderate gums inflammation (gingivitis grade II, in particular all gingival scores for the mean should be between 1.75 and...
- 40% of the people with localized gingivitis (10-30% of evaluated sites with bleeding)
You likely can't join if
- people who do not meet the inclusion criteria
- Smokers people
- people planning toothcare during the study period
- people using dental apparatus or using dental prosthesis, with generalized tooth recession, with presence of caries, with dental abscess or signs of...
- people using other dental hygiene products than provided (e.g. dental floss, interdental brushes, mouthwash, etc) during the study period
- people with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator...
See the full eligibility criteria
- Healthy male and female people (with no specific repartition)
- people of Caucasian ethnicity
- people aged between 18 and 65 years (extremes included)
- people clinically showing moderate gums inflammation (gingivitis grade II, in particular all gingival scores for the mean should be between 1.75 and 2.3, according to Löe and Silness gingival scoring system), in...
- 40% of the people with localized gingivitis (10-30% of evaluated sites with bleeding)
- 60% of them with generalized gingivitis (\>30% of evaluated sites with bleeding) Repartition to be respected in both study groups.
- people with dental plaque (total plaque score at inclusion ≥2)
- people registered with the national health service
- people certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
- people able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel
- people able to respect the instructions given by the Principal Investigator or designated personnel as well as able to respect the study constraints and specific requirements
- people who commit not to change their daily routine or lifestyle during the study
- people on stable pharmacological therapy (except for the pharmacological therapy in the non-) for at least one month without any changes expected or planned during the study
- people informed about the test procedures who have signed a consent form and privacy agreement
- people who do not meet the inclusion criteria
- Smokers people
- people planning toothcare during the study period
- people 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
- people using other dental hygiene products than provided (e.g. dental floss, interdental brushes, mouthwash, etc) during the study period
- people with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of...
- people participating or planning to participate in other clinical trials
- people who participated in a similar study without respecting an adequate washout period (at least one month)
- people that have food intolerances or food allergies to ingredients of the study product
- people under pharmacological treatments that are considered incompatible with the study requirement by the Principal Investigator
- people who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least one month)
- people admitted to a health or social facility
- people planning a hospitalization during the study
- people not able to be contacted in case of emergency
- people deprived of freedom by administrative or legal decision or under guardianship
- people who have or have had a history of alcohol or drug addiction
- people with eating disorders (i.e. bulimia, psychogenic eating disorders, etc.)
- Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
The study team makes the final eligibility decision.
Where it's taking place
- Castelldefels, Barcelona, Spain
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Castelldefels, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.