A Study to Measure the Effect of a Toothpaste Containing Proteins and Enzymes and a Fluoride Toothpaste on Gingival Health

NCT06932211 | Completed

• 1 other identifier: ORL-GUM-3328
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Change in gingival condition as measured by Gingival Index

  4 weeks and 26 weeks

• Change in plaque levels as measured by Modified Quigley and Hein Plaque Index

  4 weeks, 13 weeks and 26 weeks

Study Arms (2)

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

Toothpaste containing proteins and enzymes OTHER

Toothpaste containing proteins, enzymes and 1450 ppm fluoride as sodium fluoride

Test toothpaste

Control fluoride toothpaste OTHER

Toothpaste containing sodium fluoride at 1450 ppm F

Negative control toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unilever R&D: lead

Study Sites (1)

Hospital of Stomatology, Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

Related Publications (1)

• 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.

  PMID: 41184910 DERIVED

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Interventions

Enzymes

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Intervention Hierarchy (Ancestors)

Enzymes and Coenzymes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 17, 2025
• Study Start: October 29, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)