Trial · NCT02709785

SmartMouth Advanced Clinical Formula Clinical Research Design Protocol

NCT02709785, Not applicable, Completed, St. Louis University; results first posted 2018-12-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SmartMouth Advanced Clinical Formula Clinical Research Design Protocol. Trials, record NCT02709785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02709785

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: SmartMouth Advanced Clinical Formula Clinical Research Design Protocol
NCT number: NCT02709785
Status: Completed
Phases: Not applicable
Enrollment: 80 participants, actual
Lead sponsor: St. Louis University
Conditions: Gingivitis, Periodontitis
Interventions: SmartMouth Clinical DDS mouthrinse, 0.12% chlorhexidine rinse, Placebo rinse
First posted: 2016-03-16
Last updated: 2018-12-04
Results first posted: 2018-12-04

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Gingival Index	6 weeks	Gingival Index scores gingival inflammation from 0 (healthy) to 3 (severe inflammation). The higher the score, the greater the gingival inflammation (worse outcome). Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.
Secondary	Calculus Index	6 weeks	Calculus Index scores the amount of calculus accumulation by adding surfaces from the lingual of the mandibular anterior teeth. The higher the score, the worse the calculus accumulation. Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.
Secondary	Tooth Stain Index	6 weeks	Tooth Stain Index scores the amount of tooth stain from 0 (no stain) to 3 (greater than 2/3 of surface). The higher the score, the worse the staining. Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used. The score (0-3) for each tooth are summed for the total score. The 8 incisor teeth are scored. The minimum score for a subject is "0" and the maximum score for a subject is "24" (worse outcome).
Secondary	Plaque Index	6 weeks	Plaque Index scores plaque accumulation from 0 (no plaque) to 5 (plaque covering 2/3 of surface or more). The higher the score, the more plaque accumulation (worse outcome). Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.
Secondary	Bleeding Score	6 weeks	Bleeding Score is determined by adding the number of bleeding sites and dividing by the number of teeth to assess gingival inflammation. The higher the score, the worse the inflammation. Differences were assessed between treatment groups for changes in values from baseline to 6 weeks. If data were normally distributed, the paired t test was used to assess changes; otherwise the Wilcoxon signed rank test was used.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Gingival Index	6 weeks	units on a scale	MEDIAN
SECONDARY	Calculus Index	6 weeks	units on a scale	MEDIAN
SECONDARY	Tooth Stain Index	6 weeks	units on a scale	MEDIAN
SECONDARY	Plaque Index	6 weeks	units on a scale	MEDIAN
SECONDARY	Bleeding Score	6 weeks	units on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Gingival Index	Group 1 SmartMouth	-0.22	Inter-Quartile Range -0.34 to -0.16	units on a scale
Gingival Index	Group 2 Chlorhexidine	-0.34	Inter-Quartile Range -0.50 to -0.17	units on a scale
Gingival Index	Group 3 Placebo	-0.19	Inter-Quartile Range -0.29 to -0.11	units on a scale
Calculus Index	Group 1 SmartMouth	-3.00	Inter-Quartile Range -7.75 to 1.75	units on a scale
Calculus Index	Group 2 Chlorhexidine	-5.00	Inter-Quartile Range -9.00 to 2.00	units on a scale
Calculus Index	Group 3 Placebo	-3.00	Inter-Quartile Range -7.00 to 0.00	units on a scale
Tooth Stain Index	Group 1 SmartMouth	0	Inter-Quartile Range -1.00 to 0.75	units on a scale
Tooth Stain Index	Group 2 Chlorhexidine	3.5	Inter-Quartile Range 1.00 to 7.00	units on a scale
Tooth Stain Index	Group 3 Placebo	0	Inter-Quartile Range -1.75 to 0.00	units on a scale
Plaque Index	Group 1 SmartMouth	-0.36	Inter-Quartile Range -0.64 to 0.00	units on a scale

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group 1 SmartMouth	24
Overall Study	STARTED	Group 2 Chlorhexidine	28
Overall Study	STARTED	Group 3 Placebo	28
Overall Study	3 Weeks	Group 1 SmartMouth	23
Overall Study	3 Weeks	Group 2 Chlorhexidine	27
Overall Study	3 Weeks	Group 3 Placebo	27
Overall Study	6 Weeks	Group 1 SmartMouth	23
Overall Study	6 Weeks	Group 2 Chlorhexidine	26
Overall Study	6 Weeks	Group 3 Placebo	27
Overall Study	COMPLETED	Group 1 SmartMouth	23

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals9

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Group 1 SmartMouth	23
Total, all-cause mortality	Group 2 Chlorhexidine	26
Total, all-cause mortality	Group 3 Placebo	27
Total, other adverse events	Group 1 SmartMouth	23
Total, other adverse events	Group 2 Chlorhexidine	26
Total, other adverse events	Group 3 Placebo	27
Total, serious adverse events	Group 1 SmartMouth	23
Total, serious adverse events	Group 2 Chlorhexidine	26
Total, serious adverse events	Group 3 Placebo	27

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02709785

GET https://conductscience.org/api/trials/v1/NCT02709785/registered

API reference For AI assistants