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Gingival InflammationNCT07415733

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

A study testing Test Toothpaste in people with Gingival Inflammation and Gingival Bleeding, run by Unilever R&D at 1 site in Indonesia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Test Toothpaste
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteIndonesia
Study dates
27 Feb 2026to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Faculty of Dentistry, University of Indonesia

    Jakarta Pusat, 10430

Other trials in Indonesia

About this study

Official title: 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.

Read the 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.

Being tested
Test Toothpaste, Control Toothpaste
Medical subject headings
Gingivitis, Gingival Hemorrhage, Dental Plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Test ToothpasteOther

    Toothpaste containing a gum-heath active and fluoride

  • Control ToothpasteOther

    Toothpaste containing fluoride

Study groups in NCT07415733
Study groupRoleWhat they receive
Test toothpaste groupExperimentalTest Toothpaste
Receives: Other: Test Toothpaste
Negative control groupActive comparatorNegative control toothpaste
Receives: Other: Control Toothpaste

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 17

  2. 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.

    Measured: Baseline, Week 17

  3. 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.

    Measured: Baseline, Week 17

Secondary outcomes (3)

  1. 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.

    Measured: Baseline, Week 4, Week 13

  2. 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.

    Measured: Baseline, Week 4, Week 13

  3. 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.

    Measured: Baseline, Week 4, Week 13

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start27 Feb 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07415733
Sponsor's protocol ID
ORL-GUM-4154
Status last verified
Sep 2026
First submitted
2 Feb 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Test Toothpaste in people with Gingival Inflammation and Gingival Bleeding, run by Unilever R&D at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in gingival condition as measured by Gingival Index (time frame: Baseline, Week 17). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07415733.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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