Trial Outcomes & Findings for SmartMouth Advanced Clinical Formula Clinical Research Design Protocol (NCT NCT02709785)

Last Updated: 2018-12-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

80 participants

Primary outcome timeframe

6 weeks

Results posted on

2018-12-04

Participant Flow

Subjects recruited from Graduate Periodontics clinic at two universities.

Participant milestones

Participant milestones
Measure	Group 1 SmartMouth 24 subjects with plaque and gingival inflammation SmartMouth Clinical DDS Advanced Oral Rinse	Group 2 Chlorhexidine 28 subjects with plaque and gingival inflammation 0.12% chlorhexidine rinse	Group 3 Placebo 28 subjects with plaque and gingival inflammation Placebo rinse
Overall Study STARTED	24	28	28
Overall Study 3 Weeks	23	27	27
Overall Study 6 Weeks	23	26	27
Overall Study COMPLETED	23	26	27
Overall Study NOT COMPLETED	1	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 SmartMouth 24 subjects with plaque and gingival inflammation SmartMouth Clinical DDS Advanced Oral Rinse	Group 2 Chlorhexidine 28 subjects with plaque and gingival inflammation 0.12% chlorhexidine rinse	Group 3 Placebo 28 subjects with plaque and gingival inflammation Placebo rinse
Overall Study Withdrawal by Subject	1	2	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 SmartMouth n=24 Participants 24 subjects with plaque and gingival inflammation SmartMouth Clinical DDS Advanced Oral Rinse	Group 2 Chlorhexidine n=28 Participants 28 subjects with plaque and gingival inflammation 0.12% chlorhexidine rinse	Group 3 Placebo n=28 Participants 28 subjects with plaque and gingival inflammation Placebo rinse	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=24 Participants	0 Participants n=28 Participants	0 Participants n=28 Participants	0 Participants n=80 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=24 Participants	28 Participants n=28 Participants	28 Participants n=28 Participants	80 Participants n=80 Participants
Age, Categorical >=65 years	0 Participants n=24 Participants	0 Participants n=28 Participants	0 Participants n=28 Participants	0 Participants n=80 Participants
Sex: Female, Male Female	13 Participants n=24 Participants	14 Participants n=28 Participants	13 Participants n=28 Participants	40 Participants n=80 Participants
Sex: Female, Male Male	11 Participants n=24 Participants	14 Participants n=28 Participants	15 Participants n=28 Participants	40 Participants n=80 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	24 Participants n=24 Participants	28 Participants n=28 Participants	28 Participants n=28 Participants	80 Participants n=80 Participants
Gingival Index	0.890 units on a scale n=24 Participants	0.970 units on a scale n=28 Participants	1.010 units on a scale n=28 Participants	0.965 units on a scale n=80 Participants
Bleeding Score	0.540 units on a scale n=24 Participants	0.640 units on a scale n=28 Participants	0.860 units on a scale n=28 Participants	0.645 units on a scale n=80 Participants
Plaque Index	1.740 units on a scale n=24 Participants	1.895 units on a scale n=28 Participants	1.680 units on a scale n=28 Participants	1.745 units on a scale n=80 Participants
Tooth Stain Index	1.000 units on a scale n=24 Participants	3.000 units on a scale n=28 Participants	3.000 units on a scale n=28 Participants	2.000 units on a scale n=80 Participants
Calculus Index	8.000 units on a scale n=24 Participants	9.500 units on a scale n=28 Participants	9.000 units on a scale n=28 Participants	9.000 units on a scale n=80 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Group 1 SmartMouth n=23 Participants 23 subjects with plaque and gingival inflammation SmartMouth Clinical DDS Advanced Oral Rinse	Group 2 Chlorhexidine n=26 Participants 26 subjects with plaque and gingival inflammation 0.12% chlorhexidine rinse	Group 3 Placebo n=27 Participants 27 subjects with plaque and gingival inflammation Placebo rinse
Gingival Index	-0.22 units on a scale Interval -0.34 to -0.16	-0.34 units on a scale Interval -0.5 to -0.17	-0.19 units on a scale Interval -0.29 to -0.11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 SmartMouth n=23 Participants 23 subjects with plaque and gingival inflammation SmartMouth Clinical DDS Advanced Oral Rinse	Group 2 Chlorhexidine n=26 Participants 26 subjects with plaque and gingival inflammation 0.12% chlorhexidine rinse	Group 3 Placebo n=27 Participants 27 subjects with plaque and gingival inflammation Placebo rinse
Calculus Index	-3.00 units on a scale Interval -7.75 to 1.75	-5.00 units on a scale Interval -9.0 to 2.0	-3.00 units on a scale Interval -7.0 to 0.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Group 1 SmartMouth n=23 Participants 23 subjects with plaque and gingival inflammation SmartMouth Clinical DDS Advanced Oral Rinse	Group 2 Chlorhexidine n=26 Participants 26 subjects with plaque and gingival inflammation 0.12% chlorhexidine rinse	Group 3 Placebo n=27 Participants 27 subjects with plaque and gingival inflammation Placebo rinse
Tooth Stain Index	0 units on a scale Interval -1.0 to 0.75	3.5 units on a scale Interval 1.0 to 7.0	0 units on a scale Interval -1.75 to 0.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 SmartMouth n=23 Participants 23 subjects with plaque and gingival inflammation SmartMouth Clinical DDS Advanced Oral Rinse	Group 2 Chlorhexidine n=26 Participants 26 subjects with plaque and gingival inflammation 0.12% chlorhexidine rinse	Group 3 Placebo n=27 Participants 27 subjects with plaque and gingival inflammation Placebo rinse
Plaque Index	-0.36 units on a scale Interval -0.64 to 0.0	-0.62 units on a scale Interval -0.91 to -0.28	-0.22 units on a scale Interval -0.62 to -0.02

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Group 1 SmartMouth n=23 Participants 23 subjects with plaque and gingival inflammation SmartMouth Clinical DDS Advanced Oral Rinse	Group 2 Chlorhexidine n=26 Participants 26 subjects with plaque and gingival inflammation 0.12% chlorhexidine rinse	Group 3 Placebo n=27 Participants 27 subjects with plaque and gingival inflammation Placebo rinse
Bleeding Score	-0.39 units on a scale Interval -0.54 to -0.13	-0.52 units on a scale Interval -0.79 to -0.18	-0.43 units on a scale Interval -0.73 to -0.21

Adverse Events

Group 1 SmartMouth

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2 Chlorhexidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 3 Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

D. Douglas Miley

Saint Louis University

Phone: 314-977-8381

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place