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Dental PlaqueNCT07255040

A Clinical Study to Evaluate the Effectiveness of an Experimental Toothpaste in Improving Gum Health and Reducing Plaque Accumulation

A study testing Test Dentifrice, Parodontax Complete Protection and Colgate Cavity Protection in people with Dental Plaque and Gingivitis, run by HALEON at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this 24-week clinical study is to evaluate the ability of an experimental dentifrice containing 0.454 percent (%) weight by weight (w/w) Stannous fluoride (SnF2); to improve gingival health, plaque reduction and prevention of plaque accumulation compared with a regular fluoride dentifrice (negative control)… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dental Plaque, Gingivitis
What is being tested?
Test Dentifrice, Parodontax Complete Protection and Colgate Cavity Protection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
284 participants
Where
1 siteUnited States
Study dates
19 Nov 2025to 30 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

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

  • Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
  • Participant is of either sex and any gender who, at the time of screening, is at least 18 years old, inclusive.
  • A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures.
  • A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant 's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.

Who cannot join

  • A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
  • A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
  • A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, psychiatric condition or laboratory abnormality or any other clinical serious or unstable conditions (example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
  • A female participant who is a pregnant (self-reported) or intending to become pregnant over the duration of the study or who is breastfeeding.
  • A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • A participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol.
Show all 24Show fewer
  • A participant who is a current smoker or an ex-smoker (including vaping) who stopped within 6 months of Screening or who is using smokeless forms of tobacco (example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
  • A participant who is diagnosed with xerostomia or is taking any medication that in the view of the investigator is causing xerostomia.
  • A participant who has a medical condition which could have directly influenced gingival bleeding (example, type 2 diabetes) or who has a bleeding disorder that could have affected study outcomes and/or participant safety.
  • A participant who has a recent history (within the last year) of alcohol or other substance abuse.
  • A participant who has a severe oral condition (example, acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant/examiner if they participate in the study.
  • Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush.
  • Dental Exclusions:
  • A participant who has active caries that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
  • A participant who has dentures (partial or full).
  • A participant who has fixed orthodontic appliances or is undergoing active or recent (within 3 months of Screening) orthodontic treatment, which in the opinion of the investigator, could interfere with study procedures, assessments or outcomes.
  • A participant who has other orthodontic devices (example, bands, fixed retainers, or removable retainers) that could, in the opinion of the investigator, interfere with study procedures, assessment or outcomes.
  • A participant who has numerous restorations in a poor state of repair.
  • A participant who has any dental condition (example, overcrowding) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
  • A participant who has had dental prophylaxis within 12 weeks of Screening.
  • A participant who has had teeth bleaching within 12 weeks of Screening.
  • A participant who has high levels of extrinsic stain or calculus deposits, in the opinion of the investigator, that could have interfered with plaque assessments.
  • A participant who has previously been enrolled in this study.
  • A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Salus Research, Inc.

    Fort Wayne, Indiana, 46825

Other trials in United States

About this study

Official title: A 24-Week, Randomised, Controlled, Examiner-blind, Clinical Study to Evaluate the Efficacy of an Experimental Stannous Fluoride Dentifrice in Improving Gingival Health and Reducing Plaque Accumulation

The aim of this 24-week clinical study is to evaluate the ability of an experimental dentifrice containing 0.454 percent (%) weight by weight (w/w) Stannous fluoride (SnF2); to improve gingival health, plaque reduction and prevention of plaque accumulation compared with a regular fluoride dentifrice (negative control) in participants with mild to moderate gingivitis.

Read the detailed description

This will be a single-center, 24-week, randomized, controlled, single blind (examiner only), 3-treatment arms, parallel group, stratified study, to evaluate the efficacy of using an experimental dentifrice containing 0.454% w/w Stannous fluoride, twice daily in reducing gingivitis and plaque accumulation in a population with clinically measurable level of gingivitis. The clinical efficacy of the experimental dentifrice will be compared to a commercially available regular fluoride dentifrice as negative control. In addition, a marketed dentifrice containing 0.454% w/w SnF2 is included as positive control to provide a well-established benchmark. Approximately 300 participants (approximately 100 per group) will be randomized to ensure approximately 270 evaluable participants (approximately 90 per group) complete the study.

Being tested
Test Dentifrice, Parodontax Complete Protection, Colgate Cavity Protection
Medical subject headings
Dental Plaque, Gingivitis

What participants receive

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

  • Test DentifriceDrug

    Experimental dentifrice containing 0.454% w/w SnF2.

  • Parodontax Complete ProtectionDrug

    Marketed dentifrice containing 0.454% w/w SnF2.

  • Colgate Cavity ProtectionDrug

    Marketed regular fluoride dentifrice.

Study groups in NCT07255040
Study groupRoleWhat they receive
Test DentifriceExperimentalParticipants will be instructed to brush their teeth thoroughly with Test Dentifrice for at least one (timed) minute twice a day (morning and evening) for 24 weeks.
Receives: Drug: Test Dentifrice
Reference Dentifrice (Positive Control)Active comparatorParticipants will be instructed to brush their teeth thoroughly with Reference Dentifrice (Positive Control) for at least one (timed) minute twice a day (morning and evening) for 24 weeks.
Receives: Drug: Parodontax Complete Protection
Reference Dentifrice (Negative Control)Active comparatorParticipants will be instructed to brush their teeth thoroughly with Reference Dentifrice (Negative Control) for at least one (timed) minute twice a day (morning and evening) for 24 weeks.
Receives: Drug: Colgate Cavity Protection

What is being measured

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

  1. Number of Bleeding Sites (Overall) at Week 24

    Number of bleeding sites will be assessed using the bleeding index (BI) assessment. BI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, six sites per tooth. The probe will be inserted approximately 1 millimeter (mm) into the gingival sulcus and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. The number of bleeding sites for each participant will be calculated as the number of tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.

    Measured: Week 24

Secondary outcomes (10)
  1. Number of Bleeding Sites (Overall) at Weeks 1, 4 and 12

    Number of bleeding sites will be assessed using the BI assessment. BI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, six sites per tooth. The probe will be inserted approximately 1 mm into the gingival sulcus and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. The number of bleeding sites for each participant will be calculated as the number of tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.

    Measured: Weeks 1, 4 and 12

  2. Number of Bleeding Sites (Interproximal) at Weeks 1, 4 and 12

    Number of bleeding sites will be assessed using the BI assessment. BI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, six sites per tooth. The probe will be inserted approximately 1 mm into the gingival sulcus and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. The number of bleeding sites for each participant will be calculated as the number of tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.

    Measured: Weeks 1, 4 and 12

  3. Number of Bleeding Sites (Interproximal) at Week 24

    Number of bleeding sites will be assessed using the BI assessment. BI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, six sites per tooth. The probe will be inserted approximately 1 mm into the gingival sulcus and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. The number of bleeding sites for each participant will be calculated as the number of tooth sites with bleeding observed immediately on probing or within 30 seconds of probing.

    Measured: Week 24

  4. Mean BI (Overall) at Weeks 1, 4, 12 and 24

    The BI is an invasive assessment of gingival bleeding. BI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, six sites per tooth. The probe will be inserted approximately 1 mm into the gingival sulcus and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. Gingival bleeding will be scored on a 3-points scale with scores ranging from 0 to 2, where 0=Absence of bleeding on probing, 1=Bleeding observed within 30 seconds of probing, 2=Bleeding observed immediately on probing. Mean BI will be calculated by taking the average over all tooth sites assessed for a participant. Lower score indicates improvement in the symptoms.

    Measured: Weeks 1, 4, 12 and 24

  5. Mean BI (Interproximal) at Weeks 1, 4, 12 and 24

    The BI is an invasive assessment of gingival bleeding. BI will be assessed for all evaluable surfaces of the facial and lingual/palatal gingiva, six sites per tooth. The probe will be inserted approximately 1 mm into the gingival sulcus and moved around the tooth from the distal interproximal area to the mesial interproximal area, gently stretching the gingival epithelium. Gingival bleeding will be scored on a 3-points scale with scores ranging from 0 to 2, where 0=Absence of bleeding on probing, 1=Bleeding observed within 30 seconds of probing, 2=Bleeding observed immediately on probing. Mean BI will be calculated by taking the average over all tooth sites assessed for a participant. Lower score indicates improvement in the symptoms.

    Measured: Weeks 1, 4, 12 and 24

  6. Mean Modified Gingival Index (MGI) (Overall) at Weeks 1, 4, 12 and 24

    The MGI assessment is a non-invasive evaluation which focuses on the visual symptoms of gingivitis (for example, redness, texture, edema). The MGI will be assessed on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth. Three scores will be recorded buccally/labially and three scores lingually/palatally using a 5-point scale ranging from 0 to 4, where 0 = Absence of inflammation, 1= Mild inflammation: slight change in color, little change in texture of any portion of the marginal or papillary gingival unit, 2=Mild inflammation: criteria as [1] but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, 4=Severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score indicates improvement in the symptoms.

    Measured: Weeks 1, 4, 12 and 24

  7. Mean MGI (Interproximal) at Weeks 1, 4, 12 and 24

    The MGI assessment is a non-invasive evaluation which focuses on the visual symptoms of gingivitis (for example, redness, texture, edema). The MGI will be assessed on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth. Three scores will be recorded buccally/labially and three scores lingually/palatally using a 5-point scale ranging from 0 to 4, where 0 = Absence of inflammation, 1= Mild inflammation: slight change in color, little change in texture of any portion of the marginal or papillary gingival unit, 2=Mild inflammation: criteria as [1] but involving the entire marginal or papillary gingival unit, 3=Moderate inflammation: glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit, 4=Severe inflammation: marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score indicates improvement in the symptoms.

    Measured: Weeks 1, 4, 12 and 24

  8. Mean Turesky Plaque Index (TPI) (Overall) at Weeks 1, 4, 12 and 24

    TPI will be used to assess plaque on all gradable teeth. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed on the facial and lingual surfaces of each scorable tooth. Three scores will be recorded buccally/labially and three scores lingually/palatally. Disclosed plaque will be scored on a scale ranging from 0-6, where 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin, 3=Band of plaque wider than 1 mm but covering less than (<)1/3 of the tooth surface, 4=Plaque covering greater than or equal to (>=)1/3 but <2/3 of the tooth surface, 5=Plaque covering >=2/3 of the tooth surface. Lower score indicates improvement in the symptoms.

    Measured: Weeks 1, 4, 12 and 24

  9. Mean TPI (Interproximal) at Weeks 1, 4, 12 and 24

    TPI will be used to assess plaque on all gradable teeth. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed on the facial and lingual surfaces of each scorable tooth. Three scores will be recorded buccally/labially and three scores lingually/palatally. Disclosed plaque will be scored on a scale ranging from 0-6, where 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin, 3=Band of plaque wider than 1 mm but covering <1/3 of the tooth surface, 4=Plaque covering >=1/3 but <2/3 of the tooth surface, 5=Plaque covering >=2/3 of the tooth surface. Lower score indicates improvement in the symptoms.

    Measured: Weeks 1, 4, 12 and 24

  10. Change in Mean TPI From Pre to Post Single Brush at Baseline

    TPI will be used to assess plaque on all gradable teeth. The plaque will first be disclosed using a plaque disclosing dye solution. The TPI will be assessed on the facial and lingual surfaces of each scorable tooth. Three scores will be recorded buccally/labially and three scores lingually/palatally. Disclosed plaque will be scored on a scale ranging from 0-6, where 0=No plaque, 1=Separate flecks of plaque at the cervical margin, 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin, 3=Band of plaque wider than 1 mm but covering <1/3 of the tooth surface, 4=Plaque covering >=1/3 but <2/3 of the tooth surface, 5=Plaque covering >=2/3 of the tooth surface. Lower score indicates improvement in the symptoms. Change in TPI will be calculated by subtracting pre brushing TPI score from post brushing TPI score at Baseline.

    Measured: Pre to Post Brushing at Baseline

Timeline

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

  1. First posted28 Nov 2025
  2. Study start19 Nov 2025
  3. Primary completion30 Jul 2026
  4. Study completion30 Jul 2026

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
284 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07255040
Sponsor's protocol ID
400034
Status last verified
Aug 2026
First submitted
19 Nov 2025
Last updated
5 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com

Questions about this trial

What is this clinical trial studying?

A study testing Test Dentifrice, Parodontax Complete Protection and Colgate Cavity Protection in people with Dental Plaque and Gingivitis, run by HALEON at 1 site in United States.

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 4 inclusion and 24 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: finished, as of the sponsor's last update on 5 Aug 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Bleeding Sites (Overall) at Week 24 (time frame: Week 24). 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 5 Aug 2026.

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