Evaluation of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem

A Randomized Clinical Study on the Effect of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem

The primary objective of this clinical study is to evaluate the impact on gingival health when participants switch to a fluoride toothpaste without gum-health actives for 4 weeks after using a proven gum-health toothpaste for 13 weeks.

Study Overview

• Status: Recruiting
• Conditions: Dental Plaque; Gingival Inflammation; Gingival Bleeding
• Intervention / Treatment: Other: Test Toothpaste; Other: Control Toothpaste

Detailed Description

This is a double-blind, randomized, controlled, parallel design study. A minimum of 150 participants (75 per group) will be enrolled according to the inclusion and exclusion criteria. The accepted participants will be randomly allocated to one of the two test products, which they will use at home twice daily for 13 weeks, followed by a switch to use a fluoride toothpaste without gum-health actives (the same formulation as the negative control) for an additional 4 weeks. Dental assessments of gingival condition, plaque levels and gingival bleeding will be performed at baseline, Weeks 4, 13 and 17. Gingival crevicular fluid (GCF) samples will be taken to detect biomarkers, and supragingival plaque samples will be collected to evaluate changes in microbial species relevant to gingival health. The Oral Health Impact Profile applied to Periodontal Disease (OHIP-14-PD) questionnaire will also be administered.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Associate Prof. Benso Sulijaya; Phone Number: (+6221) 3911502; Email: bensosulijaya@gmail.com

Study Locations

• Indonesia
  • Jakarta Pusat, Indonesia, 10430
    • Recruiting
    • Faculty of Dentistry, University of Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants need to be competent i.e., able to understand what is to take place and able to provide a free decision on agreeing to the activity/taking part in the study on this.
• Participants must be able to read and understand study instructions and any other relevant study documents.
• Have at least 20 natural teeth without subgingival calculus, including 5 assessable teeth (excluding 3rd molars) in each quadrant.
• Have a mean whole mouth BOP ≥ 10% at screening.
• Willing to follow the lifestyle and dietary restrictions as detailed in the Information Sheet for study.

Exclusion Criteria:

• Be pregnant or breastfeeding.
• Participants who participated in gum health study within 3 months prior to screening.
• Current participation in any other cosmetic studies, any dental clinical studies or clinical trials.
• Participants who have used any 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 to take part in the study would affect their wellbeing.
• Have more than three sites with a probing pocket depth (PPD) of ≥ 5 mm.
• Full or partial dentures wearers.
• Current orthodontic treatment.
• Smokers or those who have a recent smoking history, including e-cigarettes.
• Diabetics.
• Have had a dental prophylaxis in the month prior to enrolment or have one scheduled prior to the end of the study.
• 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.).
• Known allergy to any ingredient in study products.
• The participant 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test toothpaste group; Test Toothpaste	Other: Test Toothpaste; Toothpaste containing a gum-heath active and fluoride
Active Comparator: Negative control group; Negative control toothpaste	Other: Control Toothpaste; Toothpaste containing fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gingival condition as measured by Gingival Index	The gingival condition will be assessed using gingival index (GI) [1]. The scoring criteria are: 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, ulceration. Six sites on each tooth will be assessed, three on facial (buccal, mesial and distal) and three on palatal/lingual (palatal/lingual, mesial and distal) surfaces. [1] LOE H, SILNESS J. Acta Odontol Scand. 1963;21:533-551.	Baseline, Week 17
Change in plaque level as measured by Full Mouth Plaque Score	Plaque will be scored using a dichotomous index (presence or absence of plaque). The Full Mouth Plaque Score (FMPS, %) will be calculated as: (Number of sites with plaque/Total number of sites assessed) × 100 [2]. Six sites per tooth will be assessed, three on facial (buccal, mesial and distal) and three on palatal/lingual (palatal/lingual, mesial and distal) surfaces. [2] D'Elia G, Floris W, Marini L, et al. Dent J (Basel). 2023 Jul 17;11(7):172.	Baseline, Week 17
Change in gingival bleeding measured by Bleeding on Probing	Bleeding on Probing (BOP) is defined as the percentage of sites that bleed upon probing [3]. Six sites per tooth will be assessed: three on the facial surface (buccal, mesial, distal) and three on the palatal/lingual surface (palatal/lingual, mesial, distal). [3] Joss A, Adler R, Lang NP. J Clin Periodontol. 1994;21(6):402-408.	Baseline, Week 17

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gingival condition as measured by Gingival Index	The gingival condition will be assessed using gingival index (GI) [1]. The scoring criteria are: 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, ulceration. Six sites per tooth will be assessed, three on facial (buccal, mesial and distal) and three on palatal/lingual (palatal/lingual, mesial and distal) surfaces. [1] LOE H, SILNESS J. Acta Odontol Scand. 1963;21:533-551.	Baseline, Week 4, Week 13
Change in plaque level as measured by Full Mouth Plaque Score	Plaque will be scored using a dichotomous index (presence or absence of plaque). The Full Mouth Plaque Score (FMPS, %) will be calculated as: (Number of sites with plaque/Total number of sites assessed) × 100 [2]. Six sites per tooth will be assessed, three on facial (buccal, mesial and distal) and three on palatal/lingual (palatal/lingual, mesial and distal) surfaces. [2] D'Elia G, Floris W, Marini L, et al. Dent J (Basel). 2023 Jul 17;11(7):172.	Baseline, Week 4, Week 13
Change in gingival bleeding measured by Bleeding on Probing	Bleeding on Probing (BOP) is defined as the percentage of sites that bleed upon probing [3]. Six sites per tooth will be assessed: three on the facial surface (buccal, mesial, distal) and three on the palatal/lingual surface (palatal/lingual, mesial, distal). [3] Joss A, Adler R, Lang NP. J Clin Periodontol. 1994;21(6):402-408.	Baseline, Week 4, Week 13

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in oral health biomarkers and biological responses	Gingival crevicular fluid (GCF) samples will be collected from a tooth site with gingival inflammation for each participant. Biomarkers will be analyzed from GCF samples using ELISA. Supragingival plaque will be collected from the same tooth site selected for GCF sampling. The microbiological status, based on the expression of bacteria will be analyzed from plaque sample through RT-PCR.	Baseline, Week 4, Week 13 and Week 17
Change in oral health-related quality of life as measured by the Oral Health Impact Profile applied to Periodontal Disease (OHIP-14-PD) questionnaire	Quality of life will be evaluated using Oral Health Impact Profile Scale applied to Periodontal Disease (OHIP-14-PD) questionnaire [4]. The instrument consists of 14 questions covering seven dimensions: functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability and handicap. [4] Rodríguez Franco NI, Moral de la Rubia J. The Open Dentistry Journal 2018, 12:1152-1161.	Baseline, Week 4, Week 13 and Week 17

Collaborators and Investigators

• Sponsor: Unilever R&D

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Tooth Diseases; Infections; Hemorrhage; Gingival Diseases; Dental Deposits; Oral Hemorrhage; Pathological Conditions, Signs and Symptoms; Dental Plaque; Gingivitis; Gingival Hemorrhage
• Other Study ID Numbers: ORL-GUM-4154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No