Trial · NCT03988374
Clinical Efficacy Evaluation of Three Dentifrices
NCT03988374, Phase 2, Completed, Church & Dwight Company, Inc.; results first posted 2021-08-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Efficacy Evaluation of Three Dentifrices. Trials, record NCT03988374. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03988374
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Efficacy Evaluation of Three Dentifrices
- NCT number
- NCT03988374
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 319 participants, actual
- Lead sponsor
- Church & Dwight Company, Inc.
- Conditions
- Gingival Inflammation and Bleeding, Dental Plaque
- Interventions
- Dentifrices
- First posted
- 2019-06-17
- Last updated
- 2021-08-23
- Results first posted
- 2021-08-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | baseline, six weeks, 3 months and 6 months | Mean Within-Treatment Whole-Mouth Score as measured by Gingival Index (0=absence of inflammation, 1=mild inflammation: slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit, 2=mild inflammation: slight change in color, little change in texture to 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. The scale ranges from 0-4. |
| Primary | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | baseline, six week, three months, and six months | Mean Within-Treatment Whole-Mouth Score as measured by Gingival Bleeding Index (0=absence of bleeding after 30 seconds, 1= bleeding observed after 30 seconds, 2= bleeding occurs instantly). The scale ranges from 0-2. |
| Primary | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | baseline, six weeks, three months, and six months | Mean Within-Treatment Whole-Mouth Score as measured by Plaque Index (0=no visible plaque, 1=separate flecks of plaque at the cervical margin of the tooth, 2=a thin, continuous band of plaque (up to 1mm wide) at the cervical margin, 3= a band of plaque wider than 1 mm but covering less than one-third of the crown, 4=plaque covering at least one-third but less than two-thirds of the crown, 5= plaque covering two-thirds or more of the crown). The scale ranges from 0-5. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | baseline, six weeks, 3 months and 6 months | units on a scale | MEAN | |
| PRIMARY | Mean Within-Treatment Whole-Mouth Score - Gingival Bleeding Efficacy | baseline, six week, three months, and six months | units on a scale | MEAN | |
| PRIMARY | Mean Within-Treatment Whole-Mouth Score - Plaque Efficacy | baseline, six weeks, three months, and six months | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 0% Baking Soda Dentifrice | Baseline | 2.081 | Standard Deviation 0.096 | units on a scale |
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 20% Baking Soda Dentifrice | Baseline | 2.094 | Standard Deviation 0.117 | units on a scale |
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 35% Baking Soda Dentifrice | Baseline | 2.092 | Standard Deviation 0.106 | units on a scale |
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 0% Baking Soda Dentifrice | 6 weeks | 1.996 | Standard Deviation 0.138 | units on a scale |
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 20% Baking Soda Dentifrice | 6 weeks | 1.919 | Standard Deviation 0.171 | units on a scale |
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 35% Baking Soda Dentifrice | 6 weeks | 1.882 | Standard Deviation 0.174 | units on a scale |
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 0% Baking Soda Dentifrice | 3 months | 1.980 | Standard Deviation 0.155 | units on a scale |
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 20% Baking Soda Dentifrice | 3 months | 1.841 | Standard Deviation 0.198 | units on a scale |
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 35% Baking Soda Dentifrice | 3 months | 1.766 | Standard Deviation 0.229 | units on a scale |
| Mean Within-Treatment Whole-Mouth Score - Gingival Efficacy | 0% Baking Soda Dentifrice | 6 months | 1.946 | Standard Deviation 0.149 | units on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0% Baking Soda Dentifrice | 104 | |
| Overall Study | STARTED | 20% Baking Soda Dentifrice | 107 | |
| Overall Study | STARTED | 35% Baking Soda Dentifrice | 108 | |
| Overall Study | COMPLETED | 0% Baking Soda Dentifrice | 103 | |
| Overall Study | COMPLETED | 20% Baking Soda Dentifrice | 105 | |
| Overall Study | COMPLETED | 35% Baking Soda Dentifrice | 107 | |
| Overall Study | NOT COMPLETED | 0% Baking Soda Dentifrice | 1 | |
| Overall Study | NOT COMPLETED | 20% Baking Soda Dentifrice | 2 | |
| Overall Study | NOT COMPLETED | 35% Baking Soda Dentifrice | 1 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Primary discomforts | General disorders | 0% Baking Soda Dentifrice | 1 | 103 | 1 |
| other | Primary discomforts | General disorders | 20% Baking Soda Dentifrice | 11 | 105 | 11 |
| other | Primary discomforts | General disorders | 35% Baking Soda Dentifrice | 0 | 107 | 0 |
| other | Primary discomforts | General disorders | 0% Baking Soda Dentifrice | 3 | 103 | 3 |
| other | Primary discomforts | General disorders | 20% Baking Soda Dentifrice | 1 | 105 | 1 |
| other | Primary discomforts | General disorders | 35% Baking Soda Dentifrice | 0 | 107 | 0 |
| other | Primary discomforts | General disorders | 0% Baking Soda Dentifrice | 0 | 103 | 0 |
| other | Primary discomforts | General disorders | 20% Baking Soda Dentifrice | 2 | 105 | 2 |
| other | Primary discomforts | General disorders | 35% Baking Soda Dentifrice | 0 | 107 | 0 |
| other | Primary discomforts | General disorders | 0% Baking Soda Dentifrice | 0 | 103 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0% Baking Soda Dentifrice | 0 | 103 |
| Total, all-cause mortality | 20% Baking Soda Dentifrice | 0 | 105 |
| Total, all-cause mortality | 35% Baking Soda Dentifrice | 0 | 107 |
| Total, other adverse events | 0% Baking Soda Dentifrice | 4 | 103 |
| Total, other adverse events | 20% Baking Soda Dentifrice | 17 | 105 |
| Total, other adverse events | 35% Baking Soda Dentifrice | 2 | 107 |
| Total, serious adverse events | 0% Baking Soda Dentifrice | 0 | 103 |
| Total, serious adverse events | 20% Baking Soda Dentifrice | 0 | 105 |
| Total, serious adverse events | 35% Baking Soda Dentifrice | 0 | 107 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03988374
GET https://conductscience.org/api/trials/v1/NCT03988374/results?page=2