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A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.12% Chlorhexidine Mouthrinse | Active Comparator | Commercially available 0.12% Chlorhexidine mouthrinse |
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| Cosmetic mouthrinse | Active Comparator | Commercially available cosmetic mouthrinse |
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| Sterile Water | Placebo Comparator | Sterile Water |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.12% chlorhexidine mouthrinse | Drug | commercially available 0.12% chlorhexidine mouthrinse |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 4 post treatment administration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fort Wayne | Indiana | 46825 | United States |
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 were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All randomized participants were included for baseline parameters evaluation. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | Score on a scale | Day 4 post treatment administration |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Mouth Rinse | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seasonal Allergy | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Cosmetic mouthrinse | Other | Commerically available cosmetic mouthrinse |
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| Sterile water | Other | Sterile water |
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| Day 4 post treatment administration |
| 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. | Day 1 post treatment administration |
| 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. | Day 4 post treatment administration |
| 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. | Day 1 post treatment administration |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Mean Plaque Index Score | 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 millimeter [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. Plaque Index was calculated by taking average of scores over all tooth sites for a participant. | Mean | Standard Deviation | Score on a scale |
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| Title |
|---|
| Description |
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| OG000 | Test Mouth Rinse | 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. |
| OG001 | 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. |
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| 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. | 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. | Posted | Mean | Standard Error | Score on a scale | Day 4 post treatment administration |
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| 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. | 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. | Posted | Mean | Standard Error | Score on a scale | Day 1 post treatment administration |
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| 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. | 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. | Posted | Mean | Standard Error | Score on a scale | Day 4 post treatment administration |
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| 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. | 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. | Posted | Mean | Standard Error | Score on a scale | Day 1 post treatment administration |
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| 0 |
| 22 |
| 1 |
| 22 |
| EG001 | Chlorhexidine Mouth Rinse (0.12% w/v) | 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. | 0 | 22 | 1 | 22 |
| EG002 | 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. | 0 | 22 | 2 | 22 |
| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Multiple Sclerosis Relapse | Nervous system disorders | Systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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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.
| Null hypothesis was no difference between treatments being compared. | ANCOVA | ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate | <0.0001 | No adjustment for multiple comparisons was made as the primary comparison was pre-defined. | Adjusted Mean DIfference | 0.74 | 2-Sided | 95 | 0.57 | 0.92 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. | ANCOVA | ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate. | <0.0001 | No adjustment for multiple comparisons was made as the primary comparison was pre-defined. | Adjusted Mean Difference | 1.68 | 2-Sided | 95 | 1.44 | 1.93 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis was no difference between treatments being compared. | ANCOVA | ANCOVA with factors for treatment, period and subject (random) with baseline as a covariate | <0.0001 | No adjustment for multiple comparisons was made as the primary comparison was pre-defined. | Adjusted Mean Difference | 0.88 | 2-Sided | 95 | 0.68 | 1.08 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |