Healthy Subjects
Conditions
Keywords
tooth plaque
Brief summary
A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth
Interventions
DRUG0.12% chlorhexidine mouthrinse
commercially available 0.12% chlorhexidine mouthrinse
OTHERCosmetic mouthrinse
Commerically available cosmetic mouthrinse
OTHERSterile water
Sterile water
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Good general and oral health * At least 20 natural gradable teeth * Mean plaque score (Turesky Modification of the Quigley Hein Index) of greater than or equal to 2.00 at the first baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration | Day 4 post treatment administration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration | Day 4 post treatment administration | 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. |
| Plaque Index After 24 Hours of Treatment Administration | Day 1 post treatment administration | 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. |
| Interproximal Plaque Index After Day 4 of Treatment Administration | Day 4 post treatment administration | 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. |
| Interproximal Plaque Index After 24 Hours of Treatment Administration | Day 1 post treatment administration | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| All Randomized Participants All randomized participants were included for baseline parameters evaluation. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Period 1 | Protocol Violation | 0 | 1 | 0 |
| Period 2 | Adverse Event | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | All Randomized Participants |
|---|---|
| Age Continuous | 41.9 Years STANDARD_DEVIATION 14.62 |
| Mean Plaque Index Score | 3.01 Score on a scale STANDARD_DEVIATION 0.34 |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 22 | 1 / 22 | 2 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration
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.
Time frame: Day 4 post treatment administration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Mouth Rinse | Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration | 3.03 Score on a scale | Standard Error 0.1 |
| Sterile Water | Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration | 3.23 Score on a scale | Standard Error 0.11 |
Comparison: Null hypothesis was no difference between treatments being compared.p-value: 0.091595% CI: [-0.45, 0.03]ANCOVA
Secondary
Interproximal Plaque Index After 24 Hours of Treatment Administration
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.
Time frame: Day 1 post treatment administration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Mouth Rinse | Interproximal Plaque Index After 24 Hours of Treatment Administration | 1.60 Score on a scale | Standard Error 0.11 |
| Sterile Water | Interproximal Plaque Index After 24 Hours of Treatment Administration | 0.72 Score on a scale | Standard Error 0.11 |
| Sterile Water | Interproximal Plaque Index After 24 Hours of Treatment Administration | 1.57 Score on a scale | Standard Error 0.11 |
Comparison: Null hypothesis was no difference between treatments being compared.p-value: 0.72895% CI: [-0.16, 0.23]ANCOVA
Comparison: Null hypothesis was no difference between treatments being compared.p-value: <0.000195% CI: [0.68, 1.08]ANCOVA
Secondary
Interproximal Plaque Index After Day 4 of Treatment Administration
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.
Time frame: Day 4 post treatment administration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Mouth Rinse | Interproximal Plaque Index After Day 4 of Treatment Administration | 3.17 Score on a scale | Standard Error 0.1 |
| Sterile Water | Interproximal Plaque Index After Day 4 of Treatment Administration | 1.48 Score on a scale | Standard Error 0.11 |
| Sterile Water | Interproximal Plaque Index After Day 4 of Treatment Administration | 3.36 Score on a scale | Standard Error 0.11 |
Comparison: Null hypothesis was no difference between treatments being compared.p-value: 0.1195% CI: [-0.44, 0.05]ANCOVA
Comparison: Null hypothesis was no difference between treatments being compared.p-value: <0.000195% CI: [1.44, 1.93]ANCOVA
Secondary
Plaque Index After 24 Hours of Treatment Administration
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.
Time frame: Day 1 post treatment administration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Mouth Rinse | Plaque Index After 24 Hours of Treatment Administration | 1.33 Score on a scale | Standard Error 0.09 |
| Sterile Water | Plaque Index After 24 Hours of Treatment Administration | 0.58 Score on a scale | Standard Error 0.09 |
| Sterile Water | Plaque Index After 24 Hours of Treatment Administration | 1.29 Score on a scale | Standard Error 0.09 |
Comparison: Null hypothesis was no difference between treatments being compared.p-value: 0.668295% CI: [-0.14, 0.21]ANCOVA
Comparison: Null hypothesis was no difference between treatments being compared.p-value: <0.000195% CI: [0.57, 0.92]ANCOVA
Secondary
Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration
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.
Time frame: Day 4 post treatment administration
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test Mouth Rinse | 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 0.1 |
| Sterile Water | Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration | 1.36 Score on a scale | Standard Error 0.11 |
Comparison: Null hypothesis was no difference in treatments being compared.p-value: <0.000195% CI: [1.42, 1.9]ANCOVA