Gingival InflammationNCT06932211
A Study to Measure the Effect of a Toothpaste Containing Proteins and Enzymes and a Fluoride Toothpaste on Gingival Health
A study testing Toothpaste containing proteins and enzymes in people with Gingival Inflammation and Dental Plaque, run by Unilever R&D at 1 site in China.
Trial summary
This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240 healthy female and male participants aged 18-70 years will be enrolled onto the study according to the inclusion/exclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Inflammation, Dental Plaque
- What is being tested?
- Toothpaste containing proteins and enzymes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2018to 30 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Hospital of Stomatology, Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
About this study
This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240 healthy female and male participants aged 18-70 years will be enrolled onto the study according to the inclusion/exclusion criteria. The accepted participants will then be randomly allocated to one of the two test products which they will use at home, twice a day for the duration of the study. Dental assessments of gingival condition and plaque level will be conducted after 4, 13 and 26 weeks of product use at the study site.
- Conditions
- Gingival Inflammation, Dental Plaque
- Being tested
- Toothpaste containing proteins and enzymes, Control fluoride toothpaste
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste containing proteins and enzymesOther
Toothpaste containing proteins, enzymes and 1450 ppm fluoride as sodium fluoride
Control fluoride toothpasteOther
Toothpaste containing sodium fluoride at 1450 ppm F
| Study group | Role | What they receive |
|---|---|---|
| Test toothpaste | Experimental | Toothpaste containing proteins, enzymes and 1450 ppm fluoride as sodium fluoride Receives: Other: Toothpaste containing proteins and enzymes |
| Negative control toothpaste | Active comparator | Toothpaste containing 1450 ppm fluoride as sodium fluoride Receives: Other: Control fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival condition as measured by Gingival Index
The gingival condition was assessed using gingival index (GI) [1]. The scoring criteria were: 0 = Absence of inflammation; 1 = Mild inflammation - slight change in colour and little change in texture; 2 = Moderate inflammation - moderate glazing, redness, oedema, and hypertrophy (bleeding on pressure); 3 = Severe inflammation - marked redness and hypertrophy (tendency to spontaneous bleeding). Each eligible tooth was scored at six sites: facial (body, mesial, distal) and lingual (body, mesial, distal). The participant's score at each timepoint is the average of all tooth sites measured.
Measured: 13 weeks
Secondary outcomes (2)
Change in gingival condition as measured by Gingival Index
The gingival condition was assessed using gingival index (GI) [1]. The scoring criteria were: 0 = Absence of inflammation; 1 = Mild inflammation - slight change in colour and little change in texture; 2 = Moderate inflammation - moderate glazing, redness, oedema, and hypertrophy (bleeding on pressure); 3 = Severe inflammation - marked redness and hypertrophy (tendency to spontaneous bleeding). Each eligible tooth was scored at six sites: facial (body, mesial, distal) and lingual (body, mesial, distal). The participant's score at each timepoint is the average of all tooth sites measured.
Measured: 4 weeks and 26 weeks
Change in plaque levels as measured by Modified Quigley and Hein Plaque Index
Plaque was disclosed and assessed using modified Quigley and Hein plaque index (MQHPI) [2]. The scoring criteria were: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth; 3 = A band of plaque wider than one mm but covering less than 1/3 of the crown of the tooth; 4 = Plaque covering at least one-third but less than 2/3 of the crown of the tooth; 5 = Plaque covering 2/3 or more of the crown of the tooth. Each eligible tooth was scored at six sites: facial (body, mesial, distal) and lingual (body, mesial, distal). The participant's score at each timepoint is the average of all tooth sites measured.
Measured: 4 weeks, 13 weeks and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start29 Oct 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gingival InflammationStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932211
- Sponsor's protocol ID
- ORL-GUM-3328
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Consent was not obtained from participants for this purpose.
Publications
Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
PubMed 5264376LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PubMed 14121956Hu X, Zhang P, Zhang L, Matheson JR, Lin S, Sun JN, Delfanti C, Tian J, Gupta AK, Vasantharaghavan R, Huang R. The effect of enzyme and protein containing toothpaste on gingival condition: a randomised controlled study. BMC Oral Health. 2025 Nov 3;25(1):1727. doi: 10.1186/s12903-025-07096-7.
PubMed 41184910
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Measure the Effect of a Toothpaste Containing Proteins and Enzymes and a Fluoride Toothpaste on Gingival Health
- ClinicalTrials.gov ID
- NCT06932211
- Acronym / sponsor ID
- ORL-GUM-3328
- Conditions
- Gingival Inflammation, Dental Plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 17 Apr 2025 (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.
This study is a double-blind, randomised, parallel group efficacy study. A minimum of 240 healthy female and male participants aged 18-70 years will be enrolled onto the study according to the inclusion/exclusion criteria. The accepted participants will then be randomly allocated to one of the two test products which they will use at home, twice a day for the duration of the study. Dental assessments of gingival condition and plaque level will be conducted after 4, 13 and 26 weeks of product use at the study site.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test toothpaste | Experimental | Other: Toothpaste containing proteins and enzymesToothpaste containing proteins, enzymes and 1450 ppm fluoride as sodium fluoride |
| Negative control toothpaste | Active comparator | Other: Control fluoride toothpasteToothpaste containing 1450 ppm fluoride as sodium fluoride |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 |
|---|---|---|
| Toothpaste containing proteins and enzymesToothpaste containing proteins, enzymes and 1450 ppm fluoride as sodium fluoride | Other | Test toothpaste |
| Control fluoride toothpasteToothpaste containing sodium fluoride at 1450 ppm F | Other | Negative control toothpaste |
Primary outcome
Change in gingival condition as measured by Gingival Index
Time frame: 13 weeks
The gingival condition was assessed using gingival index (GI) [1]. The scoring criteria were: 0 = Absence of inflammation; 1 = Mild inflammation - slight change in colour and little change in texture; 2 = Moderate inflammation - moderate glazing, redness, oedema, and hypertrophy (bleeding on pressure); 3 = Severe inflammation - marked redness and hypertrophy (tendency to spontaneous bleeding). Each eligible tooth was scored at six sites: facial (body, mesial, distal) and lingual (body, mesial, distal). The participant's score at each timepoint is the average of all tooth sites measured.
2 secondary outcomes
Change in gingival condition as measured by Gingival Index
Time frame: 4 weeks and 26 weeks
Change in plaque levels as measured by Modified Quigley and Hein Plaque Index
Time frame: 4 weeks, 13 weeks and 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 5264376Turesky S, Gilmore ND, Glickman I. Reduced plaque formation by the chloromethyl analogue of victamine C. J Periodontol. 1970 Jan;41(1):41-3. doi: 10.1902/jop.1970.41.41.41. No abstract available.
- Background: PubMed 14121956LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
- Results publication: PubMed 41184910Hu X, Zhang P, Zhang L, Matheson JR, Lin S, Sun JN, Delfanti C, Tian J, Gupta AK, Vasantharaghavan R, Huang R. The effect of enzyme and protein containing toothpaste on gingival condition: a randomised controlled study. BMC Oral Health. 2025 Nov 3;25(1):1727. doi: 10.1186/s12903-025-07096-7.
- Individual participant dataSharing planned: No. Consent was not obtained from participants for this purpose.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste containing proteins and enzymes in people with Gingival Inflammation and Dental Plaque, run by Unilever R&D at 1 site in China.
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 8 inclusion and 15 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: finished, as of the sponsor's last update on 17 Sep 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 China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gingival condition as measured by Gingival Index (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06932211, which also lists 3 linked publications.
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 17 Sep 2026.