Trial Outcomes & Findings for Evaluate Dental Plaque Benefit of a Preventive Treatment Gel (NCT NCT03546491)
NCT ID: NCT03546491
Last Updated: 2019-09-04
Results Overview
The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (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 cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.
COMPLETED
PHASE3
32 participants
Day 4
2019-09-04
Participant Flow
Participant milestones
| Measure |
Overall Study
This was a single center, controlled, examiner-blind, randomized, 2-treatment, 3-period cross-over 4-day partial brushing plaque study. Each participant received Test product 1 (0.4% stannous fluoride preventive gel), and Test product 2 (marketed 0.243% sodium fluoride toothpaste). All subjects saw each test product at least 1 time, for the third period, each subject saw either Test product 1 or Test product 2 for a second time.
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|---|---|
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Overall Study
STARTED
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32
|
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Overall Study
Recieved Test Product 1
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32
|
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Overall Study
Received Test Product 2
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32
|
|
Overall Study
COMPLETED
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30
|
|
Overall Study
NOT COMPLETED
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2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate Dental Plaque Benefit of a Preventive Treatment Gel
Baseline characteristics by cohort
| Measure |
Overall Study
n=32 Participants
This was a controlled, examiner-blind, randomized, 2-treatment, 3-period cross-over 4-day partial brushing plaque study.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
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32 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
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21 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Asian
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2 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Ethnicity · Black or African American
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5 Participants
n=5 Participants
|
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Race/Ethnicity, Customized
Ethnicity · Not Reported
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1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White Caucasian
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24 Participants
n=5 Participants
|
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Region of Enrollment
United States
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32 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 4The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (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 cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.
Outcome measures
| Measure |
Preventive Gel
n=32 Participants
0.4% stannous fluoride
Preventive Gel: 0.4% Stannous Fluoride
|
Marketed Control
n=32 Participants
0.243 % Sodium Fluoride
Marketed Control: 0.243% Sodium Fluoride
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|---|---|---|
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Mean Turesky Modified Quigley-Hein Index at Day 4
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1.83 score on a scale
Standard Error 0.055
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1.96 score on a scale
Standard Error 0.055
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SECONDARY outcome
Timeframe: BaselineThe Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (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 cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.
Outcome measures
| Measure |
Preventive Gel
n=32 Participants
0.4% stannous fluoride
Preventive Gel: 0.4% Stannous Fluoride
|
Marketed Control
n=32 Participants
0.243 % Sodium Fluoride
Marketed Control: 0.243% Sodium Fluoride
|
|---|---|---|
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Mean Turesky Modified Quigley-Hein Index at Baseline
|
2.19 score on a scale
Standard Error 0.07
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2.22 score on a scale
Standard Error 0.07
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SECONDARY outcome
Timeframe: Day 4Total percent dental plaque area
Outcome measures
| Measure |
Preventive Gel
n=32 Participants
0.4% stannous fluoride
Preventive Gel: 0.4% Stannous Fluoride
|
Marketed Control
n=32 Participants
0.243 % Sodium Fluoride
Marketed Control: 0.243% Sodium Fluoride
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|---|---|---|
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Digital Plaque Imaging
|
8.14 percentage of plaque area
Standard Error 0.871
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10.95 percentage of plaque area
Standard Error 0.871
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SECONDARY outcome
Timeframe: BaselineTotal percent dental plaque area
Outcome measures
| Measure |
Preventive Gel
n=32 Participants
0.4% stannous fluoride
Preventive Gel: 0.4% Stannous Fluoride
|
Marketed Control
n=32 Participants
0.243 % Sodium Fluoride
Marketed Control: 0.243% Sodium Fluoride
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|---|---|---|
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Overall Baseline Mean Digital Plaque Imaging
|
6.57 percentage of plaque area
Standard Error 1.18
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7.29 percentage of plaque area
Standard Error 1.18
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Adverse Events
Preventive Gel
Marketed Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Preventive Gel
n=32 participants at risk
0.4% stannous fluoride preventive gel
|
Marketed Control
n=32 participants at risk
0.243% sodium fluoride toothpaste
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|---|---|---|
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Gastrointestinal disorders
Irritation Gum
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6.2%
2/32 • Adverse event data were collected for the entire duration of the study for each intervention.
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6.2%
2/32 • Adverse event data were collected for the entire duration of the study for each intervention.
|
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Gastrointestinal disorders
Irritation Lip
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0.00%
0/32 • Adverse event data were collected for the entire duration of the study for each intervention.
|
3.1%
1/32 • Adverse event data were collected for the entire duration of the study for each intervention.
|
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Gastrointestinal disorders
Desquamation Oral
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3.1%
1/32 • Adverse event data were collected for the entire duration of the study for each intervention.
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3.1%
1/32 • Adverse event data were collected for the entire duration of the study for each intervention.
|
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Gastrointestinal disorders
Irritation Mouth
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15.6%
5/32 • Adverse event data were collected for the entire duration of the study for each intervention.
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6.2%
2/32 • Adverse event data were collected for the entire duration of the study for each intervention.
|
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Infections and infestations
Herpetic Lesion Oral
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3.1%
1/32 • Adverse event data were collected for the entire duration of the study for each intervention.
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0.00%
0/32 • Adverse event data were collected for the entire duration of the study for each intervention.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place