Open-label Trial Evaluating Four Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste, and… (NCT05999175) | Clinical Trial Compass
CompletedNot Applicable
Open-label Trial Evaluating Four Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste, and Mouthwash
Italy84 participantsStarted 2022-05-17
Plain-language summary
The purpose of this open-label, randomized controlled clinical trial, is to provide preliminary clinical data (efficacy on plaque and gingival sensitivity, and safety and tolerability of two types of toothpaste, a mouthwash, and a specifically custom-designed toothbrush used for 28 days), as well as descriptive data on the effects of the products on oral microbiota rebalancing and patient acceptability. Eighty-four participants with a history of poor oral hygiene are visited at baseline and after 28 days of administration of the tested products. The control group consisted of 12 participants who continued to use their oral care products without changing their normal routine. At baseline and at the end of treatment (final visit), the oral microbiome is also evaluated in a group of 12 subjects allocated randomly.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy Caucasian males and females aged ≥ 18 to ≤ 65 years included.
* Proper oral hygiene not performed verified with Simplified Oral Hygiene Index (OHI-S) (score ≥ 2) and a questionnaire on oral habit.
* Patients able to comply with the requirements for the study and freely willing to provide written informed consent to the collection of their data.
* Registered with Italian National Health Service (NHS).
* Ability to understand the language used in the investigation center and to comply with the study procedures.
* Unbanned pharmacological therapy stable for at least one month without any changes during the study.
* Commitment not to change the daily routine and lifestyle.
Exclusion Criteria:
* Allergies or sensitivity to oral care products, cosmetic products, drugs, patch or medical devices.
* Any oral cavity condition inappropriate for participation.
* Gums bleeding due to pathologies/pharmacological treatment.
* Concomitant or during the last week antibiotic therapy.
* Smokers (≥5 cigarettes/day).
* Acute, chronic or progressive diseases/illness/conditions able to interfere with the outcome of the study or considered dangerous or incompatible with the study requirements.
* Pathological staining of teeth.
* Breast-feeding, pregnancy, or women of child-bearing age unwilling to take the necessary precautions to avoid pregnancy during the study.
* Planning to participate or participation in other clinical trials withing 30 days.
* Hospitalization/p…