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

NCT07415733 | Recruiting

• 1 other identifier: ORL-GUM-4154
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gingival Inflammation; Gingival Bleeding; Dental Plaque

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in gingival condition as measured by Gingival Index

  Baseline, Week 4, Week 13

• Change in plaque level as measured by Full Mouth Plaque Score

  Baseline, Week 4, Week 13

• Change in gingival bleeding measured by Bleeding on Probing

  Baseline, Week 4, Week 13

Other Outcomes (2)

• Change in oral health biomarkers and biological responses

  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

  Baseline, Week 4, Week 13 and Week 17

Study Arms (2)

Test toothpaste group

EXPERIMENTAL

Test Toothpaste

Other: Test Toothpaste

Negative control group

ACTIVE COMPARATOR

Negative control toothpaste

Other: Control Toothpaste

Interventions

Test Toothpaste OTHER

Toothpaste containing a gum-heath active and fluoride

Test toothpaste group

Control Toothpaste OTHER

Toothpaste containing fluoride

Negative control group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unilever R&D: lead

Study Sites (1)

Faculty of Dentistry, University of Indonesia

Jakarta Pusat, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Gingivitis; Gingival Hemorrhage; Dental Plaque

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Dental Deposits; Tooth Diseases

Central Study Contacts

Associate Prof. Benso Sulijaya

CONTACT

(+6221) 3911502; bensosulijaya@gmail.com

Study Design

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

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 17, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)