A Study to Measure the Effect of a Toothpaste Containing... | NCT06932211

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test toothpaste	Experimental	Toothpaste containing proteins, enzymes and 1450 ppm fluoride as sodium fluoride	Other: Toothpaste containing proteins and enzymes
Negative control toothpaste	Active Comparator	Toothpaste containing 1450 ppm fluoride as sodium fluoride	Other: Control fluoride toothpaste

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Toothpaste containing proteins and enzymes	Other	Toothpaste containing proteins, enzymes and 1450 ppm fluoride as sodium fluoride	Test toothpaste

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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. [1] LOE H, SILNESS J. Acta Odontol Scand. 1963;21:533-551.	13 weeks

Secondary Outcomes

Measure	Description	Time Frame
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. [1] LOE H, SILNESS J. Acta Odontol Scand. 1963;21:533-551.

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of Stomatology, Xi'an Jiaotong University		Xi'an	Shaanxi	710004	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41184910	Derived	Hu 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.

ID	Term
D005891	Gingivitis
D003773	Dental Plaque