Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste
2 other identifiers
interventional
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2026
CompletedFirst Posted
Study publicly available on registry
September 30, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
September 30, 2026
September 1, 2026
10 months
September 24, 2026
September 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline, 1 Month, 2 Months, and 3 Months
Secondary Outcomes (4)
Gingival inflammation using Löe & Silness Gingival Index (1963)
Baseline, 1 Month, 2 Months, and 3 Months
Bleeding on Probing (BOP)
Baseline, 1 Month, 2 Months, and 3 Months
Teeth staining using Lang Stain Index (1981)
Baseline, 1 Month, 2 Months, and 3 Months
Patient Reported Outcome Measure (PROM)
1 Month, 2 Months, and 3 Months
Study Arms (3)
Nano Bio-Fusion (NBF) Gingival Gel
EXPERIMENTALParticipants 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.
Placebo Gel
PLACEBO COMPARATORParticipants 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.
Commercial fluoride toothpaste
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jordan University of Science and Technology, Faculty of Dentistry
Irbid, Irbid Governorate, 21166, Jordan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lana Bader, DClinDent Perio
Jordan University of Science and Technology
- STUDY DIRECTOR
Duaa Almegbil
Jordan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Marwan Shahrabani
Jordan University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants and the clinical examiner will be masked to the assigned study product. An independent, unblinded assisstant who is not involved in clinical measurements will give the assigned product to each participant according to a computer generated randomisation seaquence. A code sheet will be generated where each participant's name, date of birth, and the recieved product will be recorded. All study products will be placed in identical opaque tubes to help keep the groups masked. The placebo gel will be made to look, feel, and taste like the NBF gingival gel, but it will not contain the active ingredients. The commercial fluoride toothpaste will also be placed in similar opaque tubes to maintain masking. After all participants finish thier appontments, and the examiner assesses all parameters, the code sheet will be revealed to the assessor.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr, Assistant Professor
Study Record Dates
First Submitted
September 24, 2026
First Posted
September 30, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
September 30, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Individual Participant Data (IPD) and supporting documents (such as the Study Protocol and Statistical Analysis Plan) will be made available following the publication of the study results, extending for approximately one year after study completion.
- Access Criteria
- Access will be granted to qualified researchers who submit a formal request for the data via email to the principal investigator. To receive access to the de-identified IPD and supporting documents, researchers must sign a data use agreement ensuring ethical use, strict confidentiality, and prohibition of any attempts to re-identify study participants.
Individual participant data for the Plaque Index, Gingival Index, Bleeding on Probing, Staining Index, and patient-reported outcomes will be shared. Data will be stripped of all identifiers to protect participant privacy.