- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07844993
Evaluation of the Mouthwash Effect on Maintaining Healthy Microbiome in Healthy Mouth.
Evaluation of the Efficacy of a Mouthwash in Balancing Oral pH and Maintaining a Healthy Oral Microbiome.
The goal of this study is to learn if mouthwash works to maintain healthy microbiome in subjects with healthy mouth. It will also learn about its safety. The main question it aims to answer is:
• Does the mouthwash helps to maintain healthy microbiome in balance?
Participants will:
- Use mouthwash twice a day for 2 months
- Visit the clinic as scheduled per protocol for evaluations
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ruggeri
- Telefoonnummer: +39 02 99025138
- E-mail: federica.ruggeri@complifegroup.com
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Healthy female and male subjects (without any specific repartition) subjects
- Subjects of Caucasian ethnicity
- Subjects aged between 18 and 55 years (extremes included)
- Subjects with a (resting, not stimulated) salivary pH in the range 6.0-7.0
- Subjects with baseline plaque index PCR ≥ 30% of surfaces with plaque according to O'Leary*
- Subjects with ≥ 20 natural teeth and regular consumption of dietary sugars, including soft drinks, fruit juices, and other sugar-rich foods or beverages.
- Subjects registered with the national public health system in the country where the study is conducted
- Subjects certifying the truthfulness of the personal data disclosed to the Principal Investigator or designated personnel
- Subjects able to understand the language used in the investigation centre and the information given by the Principal Investigator or designated personnel
- Subjects 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
- Subjects who commit not to change their daily routine or lifestyle during the study
- Subjects on stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least one month without any changes expected or planned during the study
- Subjects informed about the test procedures who have signed a consent form and privacy agreement
Exclusion Criteria:
- Subjects who do not meet the inclusion criteria
- Subjects with active dental caries
- Subjects with acute or chronic diseases (e.g. diabetes) able to interfere with the outcome of the study or that are considered dangerous for the subject or incompatible with the study requirements;
- Subjects participating or planning to participate in other clinical trials
- Subjects deprived of freedom by administrative or legal decision or under guardianship
- Subjects not able to be contacted in case of emergency
- Subjects admitted to a health or social facility
- Subjects planning a hospitalisation during the study
- Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
- Subjects under pharmacological treatments that are considered incompatible (e.g. antibiotics use 3 months before the study start) with the study requirement by the investigator
- Subjects having a skin disease or condition liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
- Subjects that have shown allergies or sensitivity to cosmetic products, drugs, patch or medical devices
- Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (for the women of childbearing potential).
- Subjects who are unwilling to use only the oral health and hygiene products provided as part of the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: mouthwash
|
Mouthwash will be used twice daily for 2 months |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Evolution from Baseline in the microbiome at 2 Months.
Tijdsspanne: From enrollment to the end of study at 2 months
|
Microbiome evaluation would be done by 16S rRNA gene amplification |
From enrollment to the end of study at 2 months
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PIT26/0000513
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Only data included in the publication will be shared.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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