Trial Outcomes & Findings for Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth (NCT NCT01122862)
NCT ID: NCT01122862
Last Updated: 2013-09-09
Results Overview
Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.
COMPLETED
PHASE2
23 participants
Day 4 post treatment administration
2013-09-09
Participant Flow
Participants were recruited at the clinical site.
Of 31 participants screened, 23 were randomized. 8 enrolled participants were excluded from trial before assignment to groups (3 did not meet the study criterion; remaining 5 were excluded due to other reasons).
Participant milestones
| Measure |
Test Mouth Rinse
Participants swirled their oral cavity with 15 milliliters (mL) of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Chlorhexidine Mouth Rinse (0.12%)
Participants swirled their oral cavity with 15 mL of commercially available 0.12% weight by volume (w/v) chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
|---|---|---|---|
|
Period 1
STARTED
|
8
|
8
|
7
|
|
Period 1
COMPLETED
|
8
|
7
|
7
|
|
Period 1
NOT COMPLETED
|
0
|
1
|
0
|
|
Period 2
STARTED
|
8
|
7
|
7
|
|
Period 2
COMPLETED
|
8
|
7
|
6
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
1
|
|
Period 3
STARTED
|
6
|
7
|
8
|
|
Period 3
COMPLETED
|
6
|
7
|
8
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Test Mouth Rinse
Participants swirled their oral cavity with 15 milliliters (mL) of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Chlorhexidine Mouth Rinse (0.12%)
Participants swirled their oral cavity with 15 mL of commercially available 0.12% weight by volume (w/v) chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
|---|---|---|---|
|
Period 1
Protocol Violation
|
0
|
1
|
0
|
|
Period 2
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=23 Participants
All randomized participants were included for baseline parameters evaluation.
|
|---|---|
|
Age Continuous
|
41.9 Years
STANDARD_DEVIATION 14.62 • n=93 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Mean Plaque Index Score
|
3.01 Score on a scale
STANDARD_DEVIATION 0.34 • n=93 Participants
|
PRIMARY outcome
Timeframe: Day 4 post treatment administrationPopulation: Intention to Treat (ITT) population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.
Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.
Outcome measures
| Measure |
Test Mouth Rinse
n=22 Participants
Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
n=21 Participants
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
|---|---|---|---|
|
Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration
|
3.03 Score on a scale
Standard Error 0.10
|
3.23 Score on a scale
Standard Error 0.11
|
—
|
SECONDARY outcome
Timeframe: Day 4 post treatment administrationPopulation: ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.
Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.
Outcome measures
| Measure |
Test Mouth Rinse
n=22 Participants
Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
n=21 Participants
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
|---|---|---|---|
|
Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration
|
3.03 Score on a scale
Standard Error 0.10
|
1.36 Score on a scale
Standard Error 0.11
|
—
|
SECONDARY outcome
Timeframe: Day 1 post treatment administrationPopulation: ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.
Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.
Outcome measures
| Measure |
Test Mouth Rinse
n=22 Participants
Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
n=21 Participants
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
n=22 Participants
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
|---|---|---|---|
|
Plaque Index After 24 Hours of Treatment Administration
|
1.33 Score on a scale
Standard Error 0.09
|
0.58 Score on a scale
Standard Error 0.09
|
1.29 Score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Day 4 post treatment administrationPopulation: ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.
Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.
Outcome measures
| Measure |
Test Mouth Rinse
n=22 Participants
Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
n=21 Participants
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
n=21 Participants
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
|---|---|---|---|
|
Interproximal Plaque Index After Day 4 of Treatment Administration
|
3.17 Score on a scale
Standard Error 0.10
|
1.48 Score on a scale
Standard Error 0.11
|
3.36 Score on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Day 1 post treatment administrationPopulation: ITT population: All randomized participants who received study treatment and had at least one post-baseline efficacy measurement. Due to drop outs, there was difference in number of participants analyzed for this outcome measure. Missing data was not imputed.
Plaque scores were assessed using Turesky Modification of the Quigley Hein Index and categorized as 0: No plaque; 1: Slight flecks of plaque at the cervical margin of the tooth;2: A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth;3: A band of plaque wider than 1 mm but covering less than 1/3 of the crown of the tooth;4: Plaque covering at least 1/3 but less than 2/3 of the crown of the tooth;5: Plaque covering 2/3 or more of the crown of the tooth. The interproximal plaque index was calculated by taking the average of plaque scores over the mesiofacial, distofacial, mesiolingual and distolingual surfaces in the upper and lower jaws for a participant.
Outcome measures
| Measure |
Test Mouth Rinse
n=22 Participants
Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
n=21 Participants
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
n=22 Participants
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
|---|---|---|---|
|
Interproximal Plaque Index After 24 Hours of Treatment Administration
|
1.60 Score on a scale
Standard Error 0.11
|
0.72 Score on a scale
Standard Error 0.11
|
1.57 Score on a scale
Standard Error 0.11
|
Adverse Events
Test Mouth Rinse
Chlorhexidine Mouth Rinse (0.12% w/v)
Sterile Water
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Mouth Rinse
n=22 participants at risk
Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Chlorhexidine Mouth Rinse (0.12% w/v)
n=22 participants at risk
Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
Sterile Water
n=22 participants at risk
Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
|
|---|---|---|---|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/22 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/22 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
4.5%
1/22 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/22 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/22 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
4.5%
1/22 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
|
Nervous system disorders
Multiple Sclerosis Relapse
|
4.5%
1/22 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/22 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/22 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/22 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
4.5%
1/22 • Number of events 1 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
0.00%
0/22 • All adverse events encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.
|
Additional Information
GSK Response Center
GlaxoSmithKline
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