An interventional study of Toothpaste containing proteins and enzymes and Control fluoride toothpaste in Gingival Inflammation and Dental Plaque, sponsored by Unilever R&D. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Unilever R&D (part of Unilever) · Not applicable, Interventional, and Prevention
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.
631 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's enrollment of 251 is above the median of 66 across 507 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Unilever R&D is the lead sponsor of 71 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Toothpaste containing proteins, enzymes and 1450 ppm fluoride as sodium fluoride
Other: Toothpaste containing proteins and enzymes
Toothpaste containing 1450 ppm fluoride as sodium fluoride
Other: Control fluoride toothpaste
Toothpaste containing proteins, enzymes and 1450 ppm fluoride as sodium fluoride
Toothpaste containing sodium fluoride at 1450 ppm F
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.
Time frame: 13 weeks
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.
Time frame: 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.
Time frame: 4 weeks, 13 weeks and 26 weeks
Plan to share: No — Consent was not obtained from participants for this purpose.
Ran from Oct 2018 to primary completion in Apr 2019, 6 months.
Of 53 industry-sponsored interventional studies with no phase under Gingivitis, half reached primary completion within 3 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 5. This study's 6 months is above that.
Counting every sponsor, half of 257 studies reached it within 7 months; a quarter within 3 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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