Can a Protein-Packed toothpaste outperform fluoride alone?
NCT ID NCT06932211
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing whether a toothpaste containing proteins, enzymes, and fluoride improves gum health and reduces plaque more than a standard fluoride toothpaste. The study enrolls healthy adults aged 18 to 70 with mild gum inflammation. Participants use one of the two toothpastes at home twice daily, and dentists check their gums and plaque at 4, 13, and 26 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toothpaste containing proteins, enzymes, and fluoride
- What this could lead to
- If the protein and enzyme toothpaste works better than standard fluoride toothpaste, it could offer a new way to help people keep their gums healthy at home.
- What could go wrong
- The added proteins and enzymes may not make a meaningful difference beyond regular fluoride toothpaste. Gum health depends on many factors, and results from a supervised study may not reflect everyday use.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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251 people
The number who actually took part.
- Started
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Oct 2018
- Finished
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Apr 2019
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Be in good general health. * Be willing and physically able to carry out all study procedures. * Be willing and competent (verbally and cognitively) to give written informed consent and complete a medical history form. * Have at least 20 natural teeth without subgingival calculus including 5 teeth (excluding 3rd molars) in each quadrant, which can be assessed. * Have mean Gingival Index (GI) score between 1.0 and 2.0 (1.0 ≤ Mean GI ≤ 2.0) and mean Plaque Index (PI) ≥ 1.5 at screening and baseline. * Not have had a scale and prophylaxis in the month prior to enrolment or have one scheduled prior to the end of the study. * Be willing to use only the test products for 6 months, after brushing with the products on site. * Brush teeth twice daily (once in the morning and once at night). Exclusion Criteria: * Pregnant or breast feeding mothers. * Subjects who participated in gum health study within 3 months prior to screening. * Current participation in any other cosmetic trials, any dental clinical trials or clinical trials. * Subjects who have used gum health products in the 4 weeks prior to screening. * Obvious signs of untreated caries or significant periodontal disease, which in the opinion of the study dentist, will affect either the scientific validity of the study or if the participant was to participate in the study would affect their wellbeing. * Full or partial dentures wearers. * Current orthodontic treatment. * Smokers or those who have a recent smoking history, including e-cigarettes. * Diabetics. * Medical condition and/or regular use of any medication which might affect the outcome of the study, as determined by the study dentist, principally a course of anti-inflammatory, antimicrobial or statin drugs within 4 weeks of screening. * Taking dietary supplements (e.g. multivitamins, antioxidants, fish oils, etc.). * Vegetarians and Vegans. * Allergic to any ingredient of study products. * The subject is a Unilever employee or a member of the study team. * Any participant who, in the judgement of the investigator, should not participate in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hospital of Stomatology, Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
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Other studies related to the condition(s) this trial covers.
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