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New treatment option for Periodontal Diseases
Official title Antibiotics as Adjuncts to Periodontal Therapy:Pharmacokinetic Considerations and Dosing Strategies
ClinicalTrials.gov ID: NCT04669717
What this study is testing
What is 3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days?
3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for periodontal diseases.
Also referred to as AMOXICILLINE Sandoz cpr pell 500 mg, Sandoz Pharmaceuticals AG + FLAGYL cpr pell 500 mg, Sanofi-Aventis ( Suisse) SA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Periodontitits is a bacteria induced inflammatory disease that destroys the supporting tissues of the tooth and leads to tooth loss. Treatment consists mainly of the mechanical cleaning of the tooth surfaces in order to remove the bacterial deposits (plaque and calculus).
- Phase 4: studies an already-approved treatment
- Time commitment: about 1 week
- Which group you join is decided by chance.
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 80. Healthy volunteers may be eligible.
You may be able to join if
- Informed Consent as documented by signature
- Aged 18-80 years old with need of periodontal treatment associated with adjunctive antibiotic therapy
- Presence of at least 30% of the teeth in the mouth with PD\>6mm and BOP
You likely can't join if
- Persons with systemic illnesses (uncontrolled diabetes mellitus, cancer, human immunodeficiency virus, bone metabolic diseases or disorders that...
- Pregnancy or lactation
- Persons who had taken AB within the previous 2 months
- Persons who are taking nonsteroidal anti-inflammatory drugs
- Persons who have a confirmed or suspected intolerance to 5-nitroimidazole derivatives or amoxicillin or macrolides
- Previous periodontal therapy the last 1 year
See the full eligibility criteria
- Informed Consent as documented by signature
- Aged 18-80 years old with need of periodontal treatment associated with adjunctive antibiotic therapy
- Presence of at least 30% of the teeth in the mouth with PD\>6mm and BOP
- Persons with systemic illnesses (uncontrolled diabetes mellitus, cancer, human immunodeficiency virus, bone metabolic diseases or disorders that compromise wound healing, radiation, or immunosuppressive therapy)
- Pregnancy or lactation
- Persons who had taken AB within the previous 2 months
- Persons who are taking nonsteroidal anti-inflammatory drugs
- Persons who have a confirmed or suspected intolerance to 5-nitroimidazole derivatives or amoxicillin or macrolides
- Previous periodontal therapy the last 1 year
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow due to language problems, psychological disorders, dementia, etc. of the participant
- Participants not willing to attend regular dental maintenance visits and follow-up evaluations
- Participation in another study with investigational drug within the 30 days preceding and during the present study
The study team makes the final eligibility decision.
Where it's taking place
- Geneva, Canton of Geneva, Switzerland
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 study runs about 1 week 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 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Geneva, Canton of Geneva, Switzerland. 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.