Gingival InflammationPhase 3NCT07124533
Effectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences
A Phase 3 study testing Toothpaste Tablet and Conventional Toothpaste in people with Gingival Inflammation and Dental Caries, run by Loma Linda University at 2 sites in United States.
Trial summary
Objectives: To evaluate the effectiveness of toothpaste tablets when compared to conventional dentifrices in removing plaque. Methods: 50 participants are randomized into two groups: Denttabs toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (P). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Inflammation, Dental Caries
- What is being tested?
- Toothpaste Tablet and Conventional Toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2026to Dec 2026
- Phase
- Phase 3
- 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
- Subjects are 18 years or older;
- Subjects who will comply with study protocol;
- Subjects who can read and understand the consent form;
- Subjects available during the study period;
- Subjects have more than 20 teeth.
Who cannot join
- 1. Subjects under the age of 18.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Loma Linda University Health
Loma Linda, California, 92350
Loma Linda University
Loma Linda, California, 92350
About this study
Official title: Effectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences: A 6-week Randomized Controlled Trial
Objectives: To evaluate the effectiveness of toothpaste tablets when compared to conventional dentifrices in removing plaque.
Methods: 50 participants are randomized into two groups: Denttabs toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (P). Both groups utilize their assigned dentifrice for 6 weeks. A pre and post-assessment measures the Gingival Index (GI) and Plaque Index (PI) and Decayed, Missing and Filled Teeth (DMFT). A questionnaire on the use of the product is distributed at the end of the study.
- Conditions
- Gingival Inflammation, Dental Caries
- Being tested
- Toothpaste Tablet, Conventional Toothpaste
- Keywords
- Gingival Index, Plaque Index, Dentifrice, Toothpaste Tablets, Caries Experiences, Consumer Satisfaction
- Medical subject headings
- Gingivitis, Dental Caries, Consumer Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste TabletDrug
Also called Denttabs Toothpaste Tablets
Denttabs toothpaste tablets
Conventional ToothpasteDrug
Also called Colgate Cavity Protection
Colgate Cavity Protection toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Toothpaste Tablet | Experimental | Subjects are instructed to use one toothpaste tablet at each brushing. Brushing is recommended twice daily for two minutes. Receives: Drug: Toothpaste Tablet |
| Conventional Toothpaste | Active comparator | Subjects are instructed to use the toothpaste at each brushing. Brushing is recommended twice daily for two minutes. Receives: Drug: Conventional Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index Score at Baseline
The quantity of plaque build-up is measured visually using the Quigley-Hein Plaque Index. The Plaque index can range from 0 to 5, with higher numbers indicating more plaque build-up.
Measured: Change between baseline at visit 1 and visit 2, six weeks post baseline
Gingival Index Score at Baseline
The severity of gingival inflammation is measured visually using the Loe-Silness Gingival Index. Gingival index can range from 0 to 3, with higher numbers indicating more gingival inflammation.
Measured: Change between baseline at visit 1 and visit 2, six weeks post baseline
Secondary outcomes (2)
DMFT Score at Baseline
Caries experiences is measured visually using the DMFT index. DMFT score can range from 0 to 28, with higher numbers indicating higher caries experiences.
Measured: Change between baseline at visit 1 and visit 2, six weeks post baseline
Subject Perception of Product Use
The perception on the product usage is measured using a survey containing questions on feel, texture, flavor, ease of use, eco-friendliness, cost and overall satisfaction. Response is on a 4 point Likert scale ranging from strongly agree (1) to strongly disagree (4).
Measured: Visit 2 six weeks post study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study startDec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival InflammationStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- So Ran Kwon, DDS, MS, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124533
- Sponsor's protocol ID
- 5250357
- Status last verified
- Jul 2026
- First submitted
- 8 Aug 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences: A 6-week Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07124533
- Acronym / sponsor ID
- 5250357
- Conditions
- Gingival Inflammation, Dental Caries
- Keywords
- Gingival Index, Plaque Index, Dentifrice, Toothpaste Tablets, Caries Experiences, Consumer Satisfaction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Aug 2025 (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.
Objectives: To evaluate the effectiveness of toothpaste tablets when compared to conventional dentifrices in removing plaque.
Methods: 50 participants are randomized into two groups: Denttabs toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (P). Both groups utilize their assigned dentifrice for 6 weeks. A pre and post-assessment measures the Gingival Index (GI) and Plaque Index (PI) and Decayed, Missing and Filled Teeth (DMFT). A questionnaire on the use of the product is distributed at the end of the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toothpaste Tablet | Experimental | Drug: Toothpaste TabletSubjects are instructed to use one toothpaste tablet at each brushing. Brushing is recommended twice daily for two minutes. |
| Conventional Toothpaste | Active comparator | Drug: Conventional ToothpasteSubjects are instructed to use the toothpaste at each brushing. Brushing is recommended twice daily for two minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects are 18 years or older;
- Subjects who will comply with study protocol;
- Subjects who can read and understand the consent form;
- Subjects available during the study period;
- Subjects have more than 20 teeth.
Key exclusion criteria (1 listed)
- 1. Subjects under the age of 18.
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 |
|---|---|---|
| Toothpaste TabletAlso: Denttabs Toothpaste TabletsDenttabs toothpaste tablets | Drug | Toothpaste Tablet |
| Conventional ToothpasteAlso: Colgate Cavity ProtectionColgate Cavity Protection toothpaste | Drug | Conventional Toothpaste |
Primary outcome
Plaque Index Score at Baseline
Time frame: Change between baseline at visit 1 and visit 2, six weeks post baseline
The quantity of plaque build-up is measured visually using the Quigley-Hein Plaque Index. The Plaque index can range from 0 to 5, with higher numbers indicating more plaque build-up.
Gingival Index Score at Baseline
Time frame: Change between baseline at visit 1 and visit 2, six weeks post baseline
The severity of gingival inflammation is measured visually using the Loe-Silness Gingival Index. Gingival index can range from 0 to 3, with higher numbers indicating more gingival inflammation.
2 secondary outcomes
DMFT Score at Baseline
Time frame: Change between baseline at visit 1 and visit 2, six weeks post baseline
Subject Perception of Product Use
Time frame: Visit 2 six weeks post study enrollment
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 10 Jul 2026.
- Individual participant dataSharing planned: No
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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.
So Ran Kwon, DDS, MS, PhD principal investigator
Loma Linda University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toothpaste Tablet and Conventional Toothpaste in people with Gingival Inflammation and Dental Caries, run by Loma Linda University at 2 sites 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 5 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact So Ran Kwon, DDS, MS, PhD (909 558 5118 ext. 55118, sorankwon@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index Score at Baseline (time frame: Change between baseline at visit 1 and visit 2, six weeks post baseline). The study lists 2 primary outcomes in all. 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 10 Jul 2026.