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Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste
Sponsor: King Abdullah University Hospital
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.
Official title: Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste: A Double-Blinded Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
17 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2026-10
Completion Date
2027-09
Last Updated
2026-09-30
Healthy Volunteers
Yes
Conditions
Interventions
Nano Bio-Fusion (NBF) Gingival Gel
Participants in this group serve as the test group and will use the Nano-Bio Fusion (NBF) gingival gel, which is a toothpaste-like gel with bioadhesive properties created using nanotechnology. The gel uses nano-sized particles to improve adhesion and cellular uptake in the moist oral environment, and it is formulated with naturally derived active ingredients, including antioxidants (vitamins C and E), bee propolis, aloe vera, green tea extract, olive oil, and mastic oil. They will apply a pea-sized amount of the gel to a standardized soft-bristled toothbrush and brush all tooth surfaces and the gumline using the Modified Bass technique. Participants are required to brush thoroughly twice daily (in the morning after breakfast and at night before bed) for 2 minutes per session over a 3-month follow-up period.
Placebo Gel
Participants in this group serve as the placebo control to isolate the specific effects of the active ingredients. They will use a custom-formulated placebo gel developed by NanoCureTech that exactly matches the color, consistency, and flavor of the NBF gel, but lacks the active nano-bio fusion ingredients. Participants in this arm will apply a pea-sized amount of the placebo gel to a standard soft-bristled toothbrush and brush all tooth surfaces and the gumline using the Modified Bass technique. Participants are required to brush thoroughly twice daily (in the morning after breakfast and at night before bed) for 2 minutes per session over a 3-month follow-up period.
Commercial fluoride toothpaste
Participants in this group serve as the positive control, representing the current standard of oral hygiene. They will use a commercial dentifrice (Colgate maximum cavity protection) that contains 1450 ppm fuoride (1.1% sodium monofluorophosphate), calicium, and arginine, along with standard toothpaste excipients. To maintain blinding, it will be dispensed in identical opaque tubes. Participants in this arm will apply a pea-sized amount of the toothpaste to a standard soft-bristled toothbrush and brush all tooth surfaces and the gumline using the Modified Bass technique. Participants are required to brush thoroughly twice daily (in the morning after breakfast and at night before bed) for 2 minutes per session over a 3-month follow-up period.
Locations (1)
Jordan University of Science and Technology, Faculty of Dentistry
Irbid, Irbid Governorate, Jordan