Trial Outcomes & Findings for Efficacy of Three Experimental Toothpastes to Remove Plaque (NCT NCT02992691)
NCT ID: NCT02992691
Last Updated: 2019-05-29
Results Overview
The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth. Score range 0-5.Lower scores indicate less plaque area.
COMPLETED
NA
75 participants
Up to 5 weeks
2019-05-29
Participant Flow
Participants were recruited at one center in Germany
A total of 100 participants were screened, out of which 25 participants were screening failure. Remaining 75 participants were enrolled in the study. Out of 75 enrolled participants, 6 did not meet eligibility criteria, 3 withdrew their consent, 10 participants, due to other reason (not specified). Remaining 56 were randomized in the study.
Participant milestones
| Measure |
Overall Study
This was a single-center, controlled, examiner-blind, five-treatment, five-period, crossover design study in healthy volunteers. Each participant received Test Product 1 (Dentifrice containing 20 percent \[%\] weight by weight \[w/w\] sodium bicarbonate), Test product 2 (Dentifrice containing 35% w/w sodium bicarbonate) Test product 3 (Dentifrice containing 50% w/w sodium bicarbonate), positive control (Dentifrice containing 67% w/w sodium bicarbonate) and negative control (Dentifrice containing 0% sodium bicarbonate and 1450 parts per million (ppm) fluoride).
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
Received Test Product 1
|
55
|
|
Overall Study
Received Test Product 2
|
55
|
|
Overall Study
Received Test Product 3
|
52
|
|
Overall Study
Received Positive Control
|
55
|
|
Overall Study
Received Negative Control
|
55
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Overall Study
This was a single-center, controlled, examiner-blind, five-treatment, five-period, crossover design study in healthy volunteers. Each participant received Test Product 1 (Dentifrice containing 20 percent \[%\] weight by weight \[w/w\] sodium bicarbonate), Test product 2 (Dentifrice containing 35% w/w sodium bicarbonate) Test product 3 (Dentifrice containing 50% w/w sodium bicarbonate), positive control (Dentifrice containing 67% w/w sodium bicarbonate) and negative control (Dentifrice containing 0% sodium bicarbonate and 1450 parts per million (ppm) fluoride).
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Efficacy of Three Experimental Toothpastes to Remove Plaque
Baseline characteristics by cohort
| Measure |
Overall Study
n=56 Participants
This was five-treatment, five-period, crossover design study. Each participant received Test Product 1 (Dentifrice containing 20 percent \[%\] weight by weight \[w/w\] sodium bicarbonate), Test product 2 (Dentifrice containing 35% w/w sodium bicarbonate) Test product 3 (Dentifrice containing 50% w/w sodium bicarbonate), positive control (Dentifrice containing 67% w/w sodium bicarbonate) and negative control (Dentifrice containing 0% sodium bicarbonate and 1450 parts per million \[ppm\] fluoride).
|
|---|---|
|
Age, Continuous
|
42.3 Years
STANDARD_DEVIATION 10.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 5 weeksPopulation: Intent to treat (ITT) population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.
The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth. Score range 0-5.Lower scores indicate less plaque area.
Outcome measures
| Measure |
Positive Control
n=55 Participants
Participant applied a full ribbon of dentifrice containing 67% w/w sodium bicarbonate and brushed their teeth for one timed minute.
|
Negative Control
n=55 Participants
Participant applied a full ribbon of dentifrice containing 0% sodium bicarbonate and 1450 ppm fluoride and brushed their teeth for one timed minute.
|
Test Product 3
Participant applied a full ribbon of dentifrice containing 50% w/w sodium bicarbonate and brushed their teeth for one timed minute.
|
Negative Control
Participant applied a full ribbon of dentifrice containing 0% w/w sodium bicarbonate and 1450 ppm fluoride brushed their teeth for one timed minute.
|
|---|---|---|---|---|
|
Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (TPI), Positive Control Versus [vs.] Negative Control
|
-0.57 Score on a Scale
Standard Deviation 0.247
|
-0.54 Score on a Scale
Standard Deviation 0.253
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 weeksPopulation: ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.
The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth. Score range 0-5.Lower scores indicate less plaque area.
Outcome measures
| Measure |
Positive Control
n=55 Participants
Participant applied a full ribbon of dentifrice containing 67% w/w sodium bicarbonate and brushed their teeth for one timed minute.
|
Negative Control
n=52 Participants
Participant applied a full ribbon of dentifrice containing 0% sodium bicarbonate and 1450 ppm fluoride and brushed their teeth for one timed minute.
|
Test Product 3
n=55 Participants
Participant applied a full ribbon of dentifrice containing 50% w/w sodium bicarbonate and brushed their teeth for one timed minute.
|
Negative Control
n=55 Participants
Participant applied a full ribbon of dentifrice containing 0% w/w sodium bicarbonate and 1450 ppm fluoride brushed their teeth for one timed minute.
|
|---|---|---|---|---|
|
Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Negative Control)
|
-0.56 Score on a scale
Standard Deviation 0.250
|
-0.55 Score on a scale
Standard Deviation 0.231
|
-0.55 Score on a scale
Standard Deviation 0.243
|
-0.54 Score on a scale
Standard Deviation 0.253
|
SECONDARY outcome
Timeframe: Up to 5 weeksPopulation: ITT population was the primary population of analysis. The ITT population was defined as those participants who were randomized, received at least one dose of study product and had at least one post-baseline efficacy measurement.
The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.
Outcome measures
| Measure |
Positive Control
n=55 Participants
Participant applied a full ribbon of dentifrice containing 67% w/w sodium bicarbonate and brushed their teeth for one timed minute.
|
Negative Control
n=55 Participants
Participant applied a full ribbon of dentifrice containing 0% sodium bicarbonate and 1450 ppm fluoride and brushed their teeth for one timed minute.
|
Test Product 3
n=52 Participants
Participant applied a full ribbon of dentifrice containing 50% w/w sodium bicarbonate and brushed their teeth for one timed minute.
|
Negative Control
n=55 Participants
Participant applied a full ribbon of dentifrice containing 0% w/w sodium bicarbonate and 1450 ppm fluoride brushed their teeth for one timed minute.
|
|---|---|---|---|---|
|
Change From Baseline (Pre-brushing) After a Single Brushing Treatment (Post-brushing) Turesky Modification of Quigley Hein Plaque Index (Test Product 1, 2 and 3 vs Positive Control)
|
-0.56 Score on a scale
Standard Deviation 0.250
|
-0.55 Score on a scale
Standard Deviation 0.231
|
-0.55 Score on a scale
Standard Deviation 0.243
|
-0.57 Score on a scale
Standard Deviation 0.247
|
Adverse Events
Test Product 1
Test Product 2
Test Product 3
Positive Control
Negative Control
Serious adverse events
| Measure |
Test Product 1
n=55 participants at risk
Participant applied a full ribbon of dentifrice containing 20% w/w sodium bicarbonate and brushed their teeth for one timed minute.
|
Test Product 2
n=55 participants at risk
Participant applied a full ribbon of dentifrice containing 35% w/w sodium bicarbonate and brushed their teeth for one timed minute.
|
Test Product 3
n=52 participants at risk
Participant applied a full ribbon of dentifrice containing 50% w/w sodium bicarbonate and brushed their teeth for one timed minute.
|
Positive Control
n=55 participants at risk
Participant applied a full ribbon of dentifrice containing 67% w/w sodium bicarbonate and brushed their teeth for one timed minute.
|
Negative Control
n=55 participants at risk
Participant applied a full ribbon of dentifrice containing 0% w/w sodium bicarbonate and 1450 ppm fluoride brushed their teeth for one timed minute.
|
|---|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.6%
2/55 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
1.9%
1/52 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
|
Infections and infestations
Gingivitis
|
1.8%
1/55 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
3.8%
2/52 • Up to 5 weeks
|
1.8%
1/55 • Up to 5 weeks
|
1.8%
1/55 • Up to 5 weeks
|
|
Infections and infestations
Oral Herpes
|
1.8%
1/55 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
3.8%
2/52 • Up to 5 weeks
|
3.6%
2/55 • Up to 5 weeks
|
3.6%
2/55 • Up to 5 weeks
|
|
Infections and infestations
Angular Cheilitis
|
0.00%
0/55 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
0.00%
0/52 • Up to 5 weeks
|
1.8%
1/55 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
|
Infections and infestations
Pulpitis Dental
|
0.00%
0/55 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
0.00%
0/52 • Up to 5 weeks
|
1.8%
1/55 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
|
Gastrointestinal disorders
Gingival Erythema
|
1.8%
1/55 • Up to 5 weeks
|
1.8%
1/55 • Up to 5 weeks
|
3.8%
2/52 • Up to 5 weeks
|
3.6%
2/55 • Up to 5 weeks
|
1.8%
1/55 • Up to 5 weeks
|
|
Gastrointestinal disorders
Oral Mucosal Erythema
|
0.00%
0/55 • Up to 5 weeks
|
1.8%
1/55 • Up to 5 weeks
|
0.00%
0/52 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
1.8%
1/55 • Up to 5 weeks
|
|
Gastrointestinal disorders
Tongue Coated
|
0.00%
0/55 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
1.9%
1/52 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
1.8%
1/55 • Up to 5 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal Erythema
|
0.00%
0/55 • Up to 5 weeks
|
1.8%
1/55 • Up to 5 weeks
|
0.00%
0/52 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar Erythema
|
0.00%
0/55 • Up to 5 weeks
|
1.8%
1/55 • Up to 5 weeks
|
0.00%
0/52 • Up to 5 weeks
|
0.00%
0/55 • Up to 5 weeks
|
1.8%
1/55 • Up to 5 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER