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Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste

14 oktober 2026 uppdaterad av: Lana Bader, King Abdullah University Hospital

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

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Standardized Brushing Protocol:

  • All participants, regardless of group, will receive a new soft-bristled toothbrush (the same model for everyone) at the start of the study.
  • All products will be used similarly: a pea-sized amount applied to a toothbrush to brush all tooth surfaces.
  • Participants will be instructed in the Modified Bass technique to ensure consistent mechanical plaque removal.
  • To enhance compliance and technique, the first use of the product will be supervised by the clinician who will reinforce proper brushing method.
  • Participants will brush thouroughly twice daily (morning after breakfast and night before bed) for 2 minutes each time.
  • A brushing complience sheet will be given to each participant. The sheet includes a table with the study days. Each day is divided into morining and evening toothbrushing boxes. The participant nedds to tick the box where he/she brushes their teeth using the supplied product. This sheet will be checked on each follow up appointment to ensure patient's complience.

Baseline Procedures: At the baseline visit:

  1. the examiner will record the participant plaque, gingival, and staining indices. After that, each participant will undergo professional full-mouth scaling and prophylaxis immediately after examination.
  2. After cleaning, clinical intra-oral photos will be taken for all teeth all surfaces for the buccal and palatal/lingual sites (2nd molar on the right side to the 2nd molar on the left side).
  3. Participants will receive their assigned product (NBF gel, placebo gel, or toothpaste) and toothbrush, followed by supervised first-use training. The timing of subsequent follow-up will be counted from this point.

Follow-Up Schedule:

  • Participants will be followed up for 3 months, and all outcomes will be measured at baseline, 1, 2, and 3 months. Clinical intra-oral pgotos will be taken on each time point. Baseline measurements, taken before professional cleaning and product distribution, will serve as reference values.
  • The main comparative outcome measurements will be collected at the 1, 2, and 3-month visits to assess both early and sustained effects of the interventions. This extended timeline is justified because gingival inflammation and plaque accumulation can fluctuate with oral hygiene changes over weeks to months.
  • On each follow up visit, participants will be requested to bring their brushing complience sheet and assigned toothpaste. In addition, they will be asked to perform brushing in front of the examiner. This is to ensure they are using the product and brushing correctly. Un complient participants will be excluded from the study.
  • Participants will also be reminded to avoid using any oral care product other than the one provided.

Ethical considerations regarding placebo use and follow-up period:

  • Placebo participants will not be deprived of standard oral hygiene, as they will still receive full mouth scaling at baseline and professional monitoring at every visit.
  • The use of a placebo gel for 3 months is ethically justified because all participants, including the placebo group, will perform mechanical plaque control twice daily. They are still brushing.
  • Brushing is the gold standard. Mechanical removal is the primary standard of care for plaque removal.
  • The placebo group is not being deprived of treatment, but rather serves to evaluate the specific chemical efficacy of the NBF gel. Thus, participants are not exposed to harm or deviation from standard care.
  • Any participant showing early signs of carious lesion during follow up period, will be withdrawn and provided appropriate treatment.
  • Extrinsic tooth staining is a known, reversible aesthetic side effect associated with chromogenic natural extracts. To ensure non-maleficence and maintain the highest ethical standards, all participants across all groups will be offered a complimentary professional dental prophylaxis (polishing) at the final 3-month visit to safely remove any extrinsic stains acquired during the study period.

Studietyp

Interventionell

Inskrivning (Beräknad)

45

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Jordanien
    • Irbid Governorate
      • Irbid, Irbid Governorate, Jordanien, 21166
        • Jordan University of Science and Technology, Faculty of Dentistry
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

17 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: 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-jämförare: 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.
Övrig: 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.
Aktiv komparator: 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.
Övrig: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Plaque level using Turesky Modification of the Quigley-Hein Plaque Index (TM-QHPI) (1970).
Tidsram: Baseline, 1 Month, 2 Months, and 3 Months

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Gingival inflammation using Löe & Silness Gingival Index (1963)
Tidsram: Baseline, 1 Month, 2 Months, and 3 Months

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)
Baseline, 1 Month, 2 Months, and 3 Months
Bleeding on Probing (BOP)
Tidsram: Baseline, 1 Month, 2 Months, and 3 Months

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.
Baseline, 1 Month, 2 Months, and 3 Months
Teeth staining using Lang Stain Index (1981)
Tidsram: Baseline, 1 Month, 2 Months, and 3 Months

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.
Baseline, 1 Month, 2 Months, and 3 Months
Patient Reported Outcome Measure (PROM)
Tidsram: 1 Month, 2 Months, and 3 Months

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).
1 Month, 2 Months, and 3 Months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

King Abdullah University Hospital

Samarbetspartners

Jordan University of Science and Technology

Utredare

  • Studierektor: Lana Bader, DClinDent Perio, Jordan University of Science and Technology
  • Studierektor: Duaa Almegbil, Jordan University of Science and Technology
  • Huvudutredare: Marwan Shahrabani, Jordan University of Science and Technology

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 augusti 2027

Avslutad studie (Beräknad)

1 september 2027

Studieregistreringsdatum

Först inskickad

24 september 2026

Först inskickad som uppfyllde QC-kriterierna

24 september 2026

Första postat (Faktisk)

30 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 231-2026
  • 20260306 (Annat bidrag/finansieringsnummer: Jordan University of Science and Technology)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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