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Tests treatment safety and results for Periodontitis
Official title A Pilot Study to Test the Efficacy of a Commercial Toothpaste (Cosmetic Product)
ClinicalTrials.gov ID: NCT07397312
What this study is testing
- What it's testing
- This clinical multi-center, controlled, study will be carried out in volunteers with every 3- to 6-months professional tooth cleaning during their non-treatment period between 2 re-calls of a supportive periodontitis therapy regime. The efficacy of domestic oral hygiene by using a commercial dentifrice will be determined.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent...
- Good general health with no clinically significant and relevant abnormalities of medical history.
- Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study...
- Participant with at least 16 natural, permanent teeth.
- A participant who gets regularly professional tooth cleaning in a frequence of once to twice yearly.
You likely can't join if
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate...
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to...
- A participant with an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study...
- A participant who has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, bleeding...
- A participant who has a Plaque Control Record (PCR) \> 35 %.
- A participant who plans to get pregnant during the study or is already pregnant (pregnancy testing) or breastfeeding.
See the full eligibility criteria
Who can join
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Good general health with no clinically significant and relevant abnormalities of medical history.
- Absence of any condition that would impact on the subject's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements. At Screening (Visit 1):
- Participant with at least 16 natural, permanent teeth.
- A participant who gets regularly professional tooth cleaning in a frequence of once to twice yearly.
- Participant whose biofilm contains at least Porphyromonas gingivalis.
What rules you out
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised...
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A participant with an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere...
- A participant who has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, bleeding disorders, and kidney disorders) which could have affected study...
- A participant who has a Plaque Control Record (PCR) \> 35 %.
- A participant who plans to get pregnant during the study or is already pregnant (pregnancy testing) or breastfeeding.
- A participant who is known or suspected of intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- A participant who is unwilling or unable to comply with the lifestyle considerations.
- Participant who is a current smoker (more than 5 cigarettes per day).
- Participant who is using smokeless forms of tobacco (for example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
- A participant who is diagnosed with xerostomia or is taking any medication that is causing xerostomia.
- A participant who has a recent history (within the last year) of alcohol or other substance abuse.
- A participant who has a severe oral condition (for example, necrotizing gingivitis/periodontitis or oral or peri-oral ulceration) that could compromise study outcomes or the oral health of the participant/examiner if...
- A participant who has previously been enrolled in this study. Medication exclusions at screening (Visit 1):
- A participant who is using any antibiotic medication within 3 months prior to inclusion or at any time during the study.
- A participant who is currently taking an anti-inflammatory or systemic medication (for example, immunosuppressants), which could affect plaque/gingival condition (for example, ibuprofen, aspirin, cyclosporin, phenytoin...
- A participant who has a formally untreated or not controlled periodontitis.
- A participant who has active caries that could compromise study outcomes or the oral health of the participant if they participate in the study.
- A participant who has an orthodontic appliance (bands, appliances, or fixed/ removable retainers except night guards).
- A participant who has any dental condition (for example, overcrowding) that could compromise study outcomes or the oral health of the participant if they participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Bietigheim-Bissingen, Germany
- Borna, Germany
- Straubing, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bietigheim-Bissingen, Germany; Borna, Germany; Straubing, Germany. 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.