GingivitisPhase 4NCT07414173
6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health
A Phase 4 study testing Test Mouthrinse in people with Gingivitis and Dental Plaque Accumulation, run by Colgate Palmolive at 1 site in Germany.
Trial summary
The goal of this clinical trial is to evaluate the clinical efficacy of an antimicrobial mouthrinse, with a particular focus on its effect on established plaque and the improvement of gum health. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis, Dental Plaque Accumulation
- What is being tested?
- Test Mouthrinse
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jan 2026to Nov 2026
- Phase
- Phase 4
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects aged 18-70 years, inclusive.
- Availability for the 6-month duration of the clinical research study.
- Good general health based on the opinion of the study investigator.
- Signed Informed Consent Form.
- Minimum of 20 natural teeth (excluding third molars).
- Initial gingivitis index of at least 1.5 as determined by the use of the Loe and Silness Gingival Index.
- Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Who cannot join
- Be under orthodontic treatment.
- Presence of partial removable dentures.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Participants with current moderate or severe periodontitis (periodontitis screening index [PSI] >2 in more than 2 sextants or PSI >3), and/or purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone.
- Five or more carious lesions requiring immediate restorative treatment.
- Antibiotic use any time during the one-month period prior to entry into the study.
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- Participation in any other clinical study or test panel within the one month prior to entry into the study.
- Dental prophylaxis during the past two weeks prior to baseline examinations.
- History of allergies to oral care/personal care consumer products or their ingredients.
- On any prescription medicines that might interfere with the study outcome based on the examiner/PI opinion.
- An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
- History of alcohol and/or drug abuse.
- Self-reported pregnancy and/or lactating subjects.
- Subjects with other oral diseases (including gingival hyperplasia, diseases of the oral mucosa), or any condition that the dental examiner considers exclusionary from the study.
- Smokers or/and users of tobacco products.
- Enrolled in an undergraduate, postgraduate, or academic dentistry program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
SGS proderm GmbH
Schenefeld, 22869
Arti T Nurrisyanti, MSc, +49 40 839 358 0, arti.Nurrisyanti@sgs.com
About this study
Official title: Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and the Improvement of Gum Health: a 6-month Clinical Study
The goal of this clinical trial is to evaluate the clinical efficacy of an antimicrobial mouthrinse, with a particular focus on its effect on established plaque and the improvement of gum health.
Participants will:
- Brush and rinse twice a day with the designated products for 6 months
- Visit the clinic once every 3 months after baseline for reassessment.
- Conditions
- Gingivitis, Dental Plaque Accumulation
- Being tested
- Test Mouthrinse, Control Mouthrinse
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test MouthrinseOther
Test Mouthrinse: 0.0553% NaF (250 ppm Fluoride), Amine and 0.2% Zinc Lactate dihydrate
Control MouthrinseOther
Control Mouthrinse: 0.0553% NaF(250 ppm Fluoride)
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Active comparator | Subjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds. Receives: Other: Test Mouthrinse |
| Control Group | Placebo comparator | subjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds. Receives: Other: Control Mouthrinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of gum health as measured by the Gingival Index (Löe 1967) between the study groups.
Four areas of the tooth (buccal, lingual, mesial, and distal surfaces) will be assessed. Each site is assigned a score from 0 to 3 based on clinical observation: 0 indicates normal gingiva and 3 denotes severe inflammation with marked redness, edema, ulceration, and a tendency toward spontaneous bleeding.
Measured: 6-month period
Secondary outcomes (1)
Plaque scores as measured by the Plaque Index (Turesky et al. 1970) between the study groups
The index will quantify dental plaque accumulation by assessing the facial and lingual surfaces of all teeth, typically excluding third molars. Using a disclosing solution to make the bacterial biofilm visible, the examiner will assign a score from 0 to 5 to each surface based on the extent of coverage: 0 indicates no plaque and 5 indicates plaque covering more than two-thirds of the tooth surface.
Measured: 6-month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start28 Jan 2026
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eva-Maria Axmann, Principal investigator, SGS Proderm GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414173
- Sponsor's protocol ID
- CRO-2025-10-PG-MER-MW-ZM
- Status last verified
- Jan 2026
- First submitted
- 2 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and the Improvement of Gum Health: a 6-month Clinical Study
- ClinicalTrials.gov ID
- NCT07414173
- Acronym / sponsor ID
- CRO-2025-10-PG-MER-MW-ZM
- Conditions
- Gingivitis, Dental Plaque Accumulation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the clinical efficacy of an antimicrobial mouthrinse, with a particular focus on its effect on established plaque and the improvement of gum health.
Participants will:
- Brush and rinse twice a day with the designated products for 6 months
- Visit the clinic once every 3 months after baseline for reassessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Active comparator | Other: Test MouthrinseSubjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds. |
| Control Group | Placebo comparator | Other: Control Mouthrinsesubjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female subjects aged 18-70 years, inclusive.
- Availability for the 6-month duration of the clinical research study.
- Good general health based on the opinion of the study investigator.
- Signed Informed Consent Form.
- Minimum of 20 natural teeth (excluding third molars).
Key exclusion criteria (16 listed)
- Be under orthodontic treatment.
- Presence of partial removable dentures.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Participants with current moderate or severe periodontitis (periodontitis screening index [PSI] >2 in more than 2 sextants or PSI >3), and/or purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone.
- Five or more carious lesions requiring immediate restorative treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test MouthrinseTest Mouthrinse: 0.0553% NaF (250 ppm Fluoride), Amine and 0.2% Zinc Lactate dihydrate | Other | Test Group |
| Control MouthrinseControl Mouthrinse: 0.0553% NaF(250 ppm Fluoride) | Other | Control Group |
Primary outcome
Improvement of gum health as measured by the Gingival Index (Löe 1967) between the study groups.
Time frame: 6-month period
Four areas of the tooth (buccal, lingual, mesial, and distal surfaces) will be assessed. Each site is assigned a score from 0 to 3 based on clinical observation: 0 indicates normal gingiva and 3 denotes severe inflammation with marked redness, edema, ulceration, and a tendency toward spontaneous bleeding.
1 secondary outcome
Plaque scores as measured by the Plaque Index (Turesky et al. 1970) between the study groups
Time frame: 6-month period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eva-Maria Axmann principal investigator
SGS Proderm GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Test Mouthrinse in people with Gingivitis and Dental Plaque Accumulation, run by Colgate Palmolive at 1 site in Germany.
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 7 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: looking for participants now, as of the sponsor's last update on 17 Feb 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 Germany. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of gum health as measured by the Gingival Index (Löe 1967) between the study groups. (time frame: 6-month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.