GingivitisNCT07850232
Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste
A study testing Nano Bio-Fusion (NBF) Gingival Gel and Commercial fluoride toothpaste in people with Gingivitis and Healthy Adult, run by King Abdullah University Hospital at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Healthy Adult
- What is being tested?
- Nano Bio-Fusion (NBF) Gingival Gel and Commercial fluoride toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteJordan
- Study dates
- Oct 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site
Jordan University of Science and Technology, Faculty of Dentistry
Irbid, Irbid Governorate, 21166
Lana Bader, DClinDent Perio, 0791200956, lana.bader@yahoo.com
Duaa Almegbil, dtalmegbil@just.edu.jo
About this study
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
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?
Read more
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.
Read the detailed description
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:
- 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.
- 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).
- 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.
- Conditions
- Gingivitis, Healthy Adult
- Being tested
- Nano Bio-Fusion (NBF) Gingival Gel, Placebo Gel, Commercial fluoride toothpaste
- Keywords
- NBF Gel, Dental Plaque, Gingivitis, Tooth Discoloration, Extrinsic Tooth Staining, Dentifrice, Toothpaste, Propolis, Green Tea Extract, Oral Hygiene, Patient reported outcome measures (PROM)
- Medical subject headings
- Gingivitis, Dental Plaque, Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano Bio-Fusion (NBF) Gingival GelOther
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 GelOther
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 toothpasteOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nano Bio-Fusion (NBF) Gingival Gel | Experimental | 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. Receives: Other: Nano Bio-Fusion (NBF) Gingival Gel |
| Placebo Gel | Placebo comparator | 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. Receives: Other: Placebo Gel |
| Commercial fluoride toothpaste | Active comparator | 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. Receives: Other: Commercial fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Separate flecks of plaque at the cervical (gingival) margin
- Thin continuous band of plaque (≤1 mm) at the cervical margin
- Band of plaque >1 mm wide but covering <1/3 of the crown
- Plaque covering ≥1/3 but <2/3 of the crown
- Plaque covering ≥2/3 of the crown
Measured: Baseline, 1 Month, 2 Months, and 3 Months
Secondary outcomes (4)
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)
Measured: Baseline, 1 Month, 2 Months, and 3 Months
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.
Measured: Baseline, 1 Month, 2 Months, and 3 Months
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.
Measured: Baseline, 1 Month, 2 Months, and 3 Months
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).
Measured: 1 Month, 2 Months, and 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study utilizes a double-blinded, parallel-group, randomized controlled clinical trial design Participants will be randomised to one of 3 groups: * NBF gingival gel * Placebo gel * Commercial fluoride toothpaste (Colgate) Each participant will stay in the same assigned group for the full 3-month study period. The 3 groups will be followed at the same time and compared with each other to see which product works better for plaque control, gingival inflammation reduction, and tooth staining.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Principal investigator, Lana Bader, Jordan University of Science and Technology
- Investigators
- Lana Bader, DClinDent Perio, Study director, Jordan University of Science and TechnologyDuaa Almegbil, Study director, Jordan University of Science and TechnologyMarwan Shahrabani, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850232
- Sponsor's protocol ID
- 231-2026
- Other IDs
- 20260306
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07850232
- Acronym / sponsor ID
- 231-2026
- Conditions
- Gingivitis, Healthy Adult
- Keywords
- NBF Gel, Dental Plaque, Gingivitis, Tooth Discoloration, Extrinsic Tooth Staining, Dentifrice, Toothpaste, Propolis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- Oct 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
- 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).
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study utilizes a double-blinded, parallel-group, randomized controlled clinical trial design Participants will be randomised to one of 3 groups: * NBF gingival gel * Placebo gel * Commercial fluoride toothpaste (Colgate) Each participant will stay in the same assigned group for the full 3-month study period. The 3 groups will be followed at the same time and compared with each other to see which product works better for plaque control, gingival inflammation reduction, and tooth staining.
| Arm | Type | Receives |
|---|---|---|
| Nano Bio-Fusion (NBF) Gingival Gel | Experimental | Other: Nano Bio-Fusion (NBF) Gingival GelParticipants 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 comparator | Other: Placebo GelParticipants 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 comparator | Other: Commercial fluoride toothpasteParticipants 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. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nano Bio-Fusion (NBF) Gingival GelParticipants 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. | Other | Nano Bio-Fusion (NBF) Gingival Gel |
| Placebo GelParticipants 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. | Other | Placebo Gel |
| Commercial fluoride toothpasteParticipants 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. | Other | Commercial fluoride toothpaste |
Primary outcome
Plaque level using Turesky Modification of the Quigley-Hein Plaque Index (TM-QHPI) (1970).
Time frame: 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
4 secondary outcomes
Gingival inflammation using Löe & Silness Gingival Index (1963)
Time frame: Baseline, 1 Month, 2 Months, and 3 Months
Bleeding on Probing (BOP)
Time frame: Baseline, 1 Month, 2 Months, and 3 Months
Teeth staining using Lang Stain Index (1981)
Time frame: Baseline, 1 Month, 2 Months, and 3 Months
Patient Reported Outcome Measure (PROM)
Time frame: 1 Month, 2 Months, and 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Dental Plaque, Gingivitis
Recruiting
Alpha-Lipoic Acid as an Adjunct to Non-Surgical Periodontal Treatment in Gingivitis
Gingivitis and Periodontal Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lana Bader, DClinDent Perio study director
Jordan University of Science and Technology
Duaa Almegbil study director
Jordan University of Science and Technology
Marwan Shahrabani principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nano Bio-Fusion (NBF) Gingival Gel and Commercial fluoride toothpaste in people with Gingivitis and Healthy Adult, run by King Abdullah University Hospital at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lana Bader, DClinDent Perio (+962791200956, lmbader4@just.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque level using Turesky Modification of the Quigley-Hein Plaque Index (TM-QHPI) (1970). (time frame: Baseline, 1 Month, 2 Months, and 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.