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NCT07850232
Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste
Conditions: Dental Plaque, Gingivitis, Gingival Inflammation and Bleeding, Extrinsic Tooth Staining, Patient Reported Outcome Measures
Sex: All
Ages: 17 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 45
Sponsor: King Abdullah University Hospital
Location: Jordan University of Science and Technology, Faculty of Dentistry Irbid Irbid Governorate
Summary
The goal of this clinical trial is to learn if Nanibiofusion Gingival Gel (NBF) is able to reduce dental plaque and gum inflammation in adults. The trial will also check whether daily use of NBF Gingival Gel causes tooth staining over time. The main questions it aims to answer are:
* Does NBF Gingival Gel reduce dental plaque (a sticky film of bacteria on teeth)?
* Does NBF Gingival Gel reduce gum inflammation?
* Does NBF Gingival Gel cause tooth staining?
* Are participants satisfied with the product's taste, texture, and ease of use?
Researchers will compare NBF gel to a placebo gel (a look-alike gel that contains no active ingredients), and Colgate toothpaste (a standard fluoride toothpaste). This will show if NBF gel is able to reduce plaque and gum inflammation.
Participants will:
* Be assigned to one of three groups and use their assigned product twice daily for 3 months.
* Receive a professional teeth cleaning at the start of the study, before using any product.
* Visit the clinic at baseline and at 1, 2, and 3 months for plaque, gum health, and staining checks.
* Receive a complimentary professional cleaning at the final visit to remove any staining.
* Rate the product's taste, texture, and ease of use.
Eligibility Criteria
Inclusion Criteria:
* Participants aged 17 years or older
* At least 28 natural teeth, excluding third molars
* Systemically healthy
* Clinical diagnosis of gingival and periodontal health: bleeding on probing \< 10%, with no attachment loss on any tooth.
Exclusion Criteria:
* Ongoing orthodontic appliances
* Use of antibiotics or anti-inflammatory drugs in the past 3-month
* Use of any oral care products (antiseptic mouthrinses, prescription gels) in the past month
* History of allergy to propolis or ingredients of the NBF gel
* Pregnancy or lactation
* Professional dental cleaning within the past 3 months.
* Patients with active Class II or Class V carious lesions, over-contoured crowns, overhanging restorations, or any other condition affecting plaque accumulation.
Source: ClinicalTrials.gov (NCT07850232). StuddyBuddy aggregates publicly available trial information.