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.
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.
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
Parallel
Nano Bio-Fusion (NBF) Gingival Gel
Other interventionParticipants 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
Other interventionParticipants 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
Other interventionParticipants 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.
Plaque level using Turesky Modification of the Quigley-Hein Plaque Index (TM-QHPI) (1970).
A disclosing agent (EMS biofilm doscloser) will be applied on all teeth and all surfaces to make the plaque visible. Clinical intra-oral photos will be taken for all teeth and all surafces (from 2nd molar on the right side to the 2nd molar on the other left side) for the buccal and palatal/lingual surfaces. The photos will be assessed by a blinded examiner to record plaque on the mesial, middle, and distal sites on both the buccal and lingual surfaces of the teeth. Each site will be given a score according to the following index: Score Description 0 No plaque 1. Separate flecks of plaque at the cervical (gingival) margin 2. Thin continuous band of plaque (≤1 mm) at the cervical margin 3. Band of plaque \>1 mm wide but covering \<1/3 of the crown 4. Plaque covering ≥1/3 but \<2/3 of the crown 5. Plaque covering ≥2/3 of the crown
Gingival inflammation using Löe & Silness Gingival Index (1963)
Scores will be recorded at the mesial, middle, and distal sites on both the buccal and lingual surfaces of teeth (from 2nd molar on the right side to the 2nd molar on the left side). Each site will be scored according to the following index: Score 0: Normal gingiva: Healthy appearance, No inflammation, No bleeding on probing Score 1: Mild inflammation: Slight change in color, Slight edema (swelling), No bleeding on probing Score 2: Moderate inflammation: Redness, Edema and glazing, Bleeding on probing present Score 3: Severe inflammation: Marked redness and edema, Ulceration, Spontaneous bleeding (may occur without probing)
Bleeding on Probing (BOP)
This measure serves as an objective and sensitive indicator of gingival inflammation, used to complement the Gingival Index. It is assessed by gently probing the gingiva with periodontal probe and recording bleeding as present or absent. The outcome is reported as a full-mouth Bleeding on Probing percentage for each participant. The score ranges from 0% to 100%, where 0% is equivalent to completely healthy gums with no bleeding upon probing, and higher percentages indicate more widespread gingival inflammation and poorer gum health.
Teeth staining using Lang Stain Index (1981)
Extrinsic teeth staining will be evaluated. Before the application of disclosing agent to assess plaque, clinical intra-oral photos will be taken for all teeth and all surafces (from 2nd molar on the right side to the 2nd molar on the other left side) for the buccal and palatal/lingual surfaces. The photos will be assessed by a blinded examiner to record stains on both the buccal and lingual surfaces of the teeth. Each site will be given a score according to the following index: Score 0: No discoloration, clean and polished tooth surface, natural appearance in color Score1: Slight yellowing discoloration, yellowish film over the entire extent of the clinical crown, slight brownish discoloration along the gingival margin. Score 2: Moderate brownish discoloration on the interproximal surfaces and in the apical third of the clinical crown. Score 3: Heavy brown and black discoloration over the entire extent of the tooth surface, black discoloration predomina.
Patient Reported Outcome Measure (PROM)
Participants will rate the following criteria for the used product on numeric rating scale from 0 to 10: * Taste (0 very bad taste to 10 very good taste). * Texture (0 very unpleasant to 10 very pleasant). * Foam (0 very unpleasant to 10 very pleasant). * Ease of use (0 very difficult to use to 10 very easy to use). Participants will also be asked to choose the most appropriate answer for the following questions: * Are you going to use the product after study completion? (will not ever use it again, might use it again, or will definitely use it again). * Have you noticed any teeth discoloration after using the product? (the teeth became cleaner and whiter, no change in tooth colour, teeth became more yellowish in colour). * Have you felt any gum pain or discomfort while using the product? (yes, no, sometimes). * Have you experienced any allergy after using the product? (yes, no). * Would you recommend using the product to family and friends? (yes, no, maybe).
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King Abdullah University Hospital
Lead sponsor
Jordan University of Science and Technology
Sponsor institution
Jordan University of Science and Technology
Collaborator
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