Gingival InflammationPhase 3NCT05805865
Efficacy of Eco-Friendly Toothpaste Tablets Versus Conventional Toothpaste Using PI and GI Index
A Phase 3 study testing Toothpaste Tablet and Conventional Toothpaste in people with Gingival Inflammation, run by Loma Linda University at 1 site in United States.
Trial summary
Objectives: To assess the change in gingival index (GI) and plaque index (PI) when comparing the use of toothpaste tablets to conventional toothpaste. Methods: 40 participants were randomized into two groups: Colgate's toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (C). 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
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2023to 23 Jan 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects who are pregnant and/or nursing;
- Subjects under the age of 18.
Trial locations and contacts
1 site in 1 country.
About this study
Objectives: To assess the change in gingival index (GI) and plaque index (PI) when comparing the use of toothpaste tablets to conventional toothpaste.
Methods: 40 participants were randomized into two groups: Colgate's toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (C). Both groups utilized their assigned dentifrice for 2 weeks. A pre and post-assessment measured the GI and PI index. A questionnaire on the use of the product was distributed.
- Conditions
- Gingival Inflammation
- Being tested
- Toothpaste Tablet, Conventional Toothpaste
- Keywords
- Gingival Index, Plaque Index, Dentifrice, Toothpaste Tablets, Consumer Satisfaction
- Medical subject headings
- Gingivitis, Consumer Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste TabletDrug
Colgate Anywhere Toothpaste Tablets
Conventional ToothpasteDrug
Colgate Cavity Protection
| Study group | Role | What they receive |
|---|---|---|
| Toothpaste Tablet | Experimental | Subjects are instructed to use one toothpaste tablet for brushing. Brushing is recommended twice daily for two minutes. Receives: Drug: Toothpaste Tablet |
| Conventional Toothpaste | Active comparator | Subjects are instructed to use the toothpaste for 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
Plaque was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. Plaque was disclosed and scored on each tooth surface according to the following criteria:
0: No plaque.
- Separate flecks of plaque at the cervical margin.
- A thin, continuous band of plaque (up to 1 mm) at the cer- vical margin.
- A band of plaque wider than 1 mm but covering less than 1/3 of the side of the crown of the tooth.
- Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth.
- Plaque covering 2/3 or more of the side of the crown of the tooth.
Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.
Measured: Change between baseline at visit 1 and visit 2, two weeks post baseline.
Gingival Index Score at Baseline
Gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. The gingiva adjacent to each tooth surface was scored as follows:
0 = Absence of inflammation.
- = Mild inflammation-slight change in color and little change in texture.
- = Moderate inflammation-moderate glazing, redness, edema, and hypertrophy.
- = Severe inflammation-marked redness and hypertrophy. Tendency for spontaneous bleeding.
Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.
Measured: Change between baseline at visit 1 and visit 2, two weeks post baseline.
Secondary outcomes (1)
Subject Perception of Product Use
This is a composite measurement based on questionnaire response. Subjects will answer 7 questions related to cleanliness, flavor, ease of use, eco-friendliness, willingness to switch, satisfaction, texture. This is measured on a Likert Scale from 1-4. 1 represents strongly agree with overall product satisfaction. 4 represents strongly disagree with overall product satisfaction.
Measured: Visit 2 two 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 posted10 Apr 2023
- Study start3 Jan 2023
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gingival InflammationStudies of the same condition, open and under way.
- 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
- 40 participants (actual)
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
- NCT05805865
- Sponsor's protocol ID
- 5220342
- Status last verified
- Feb 2025
- First submitted
- 28 Mar 2023
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Eco-Friendly Toothpaste Tablets Versus Conventional Toothpaste Using PI and GI Index
- ClinicalTrials.gov ID
- NCT05805865
- Acronym / sponsor ID
- 5220342
- Conditions
- Gingival Inflammation
- Keywords
- Gingival Index, Plaque Index, Dentifrice, Toothpaste Tablets, Consumer Satisfaction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 10 Apr 2023 (actual)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: To assess the change in gingival index (GI) and plaque index (PI) when comparing the use of toothpaste tablets to conventional toothpaste.
Methods: 40 participants were randomized into two groups: Colgate's toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (C). Both groups utilized their assigned dentifrice for 2 weeks. A pre and post-assessment measured the GI and PI index. A questionnaire on the use of the product was distributed.
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 for brushing. Brushing is recommended twice daily for two minutes. |
| Conventional Toothpaste | Active comparator | Drug: Conventional ToothpasteSubjects are instructed to use the toothpaste for 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 (2 listed)
- Subjects who are pregnant and/or nursing;
- 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 TabletColgate Anywhere Toothpaste Tablets | Drug | Toothpaste Tablet |
| Conventional ToothpasteColgate Cavity Protection | Drug | Conventional Toothpaste |
Primary outcome
Plaque Index Score at Baseline
Time frame: Change between baseline at visit 1 and visit 2, two weeks post baseline.
Plaque was scored according to the Turesky modification of the Quigley-Hein Plaque Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0: No plaque. 1. Separate flecks of plaque at the cervical margin. 2. A thin, continuous band of plaque (up to 1 mm) at the cer- vical margin. 3. A band of plaque wider than 1 mm but covering less than 1/3 of the side of the crown of the tooth. 4. Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth. 5. Plaque covering 2/3 or more of the side of the crown of the tooth. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.
Gingival Index Score at Baseline
Time frame: Change between baseline at visit 1 and visit 2, two weeks post baseline.
Gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was divided into six surfaces, three facial and three lingual, as follows: 1) mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. Teeth included in the scoring were: #3, 7, 12, 19, 23, 28. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation. 1. = Mild inflammation-slight change in color and little change in texture. 2. = Moderate inflammation-moderate glazing, redness, edema, and hypertrophy. 3. = Severe inflammation-marked redness and hypertrophy. Tendency for spontaneous bleeding. Subject-wise scores were determined by averaging the values obtained over all scorable surfaces in the mouth.
1 secondary outcome
Subject Perception of Product Use
Time frame: Visit 2 two weeks post study enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
So Ran Kwon, DDS, MS, PhD principal investigator
Loma Linda University
1 site 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, run by Loma Linda University 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 5 inclusion and 2 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 21 Feb 2025. 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.
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?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Plaque Index Score at Baseline (time frame: Change between baseline at visit 1 and visit 2, two 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 21 Feb 2025.