A Phase 2 interventional study of 0.12% chlorhexidine mouthrinse and Cosmetic mouthrinse in Healthy Subjects, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-09.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth
GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Commercially available 0.12% Chlorhexidine mouthrinse
Drug: 0.12% chlorhexidine mouthrinse
Commercially available cosmetic mouthrinse
Other: Cosmetic mouthrinse
Sterile Water
Other: Sterile water
commercially available 0.12% chlorhexidine mouthrinse
Commerically available cosmetic mouthrinse
Sterile water
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
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
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
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
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
Participants were recruited at the clinical site.
| Milestone | Test Mouth Rinse | Chlorhexidine Mouth Rinse (0.12%) | Sterile Water |
|---|---|---|---|
| Started | 8 | 8 | 7 |
| Completed | 8 | 7 | 7 |
| Not completed | 0 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 |
| Milestone | Test Mouth Rinse | Chlorhexidine Mouth Rinse (0.12%) | Sterile Water |
|---|---|---|---|
| Started | 8 | 7 | 7 |
| Completed | 8 | 7 | 6 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Milestone | Test Mouth Rinse | Chlorhexidine Mouth Rinse (0.12%) | Sterile Water |
|---|---|---|---|
| Started | 6 | 7 | 8 |
| Completed | 6 | 7 | 8 |
| Not completed | 0 | 0 | 0 |
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.
| Score on a scale | Test Mouth Rinse | Sterile Water |
|---|---|---|
| Plaque Index of Test Mouth Rinse Versus Sterile Water After Day 4 of Treatment Administration | 3.03 ± 0.10 | 3.23 ± 0.11 |
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.
| Score on a scale | Test Mouth Rinse | Chlorhexidine Mouth Rinse (0.12% w/v) |
|---|---|---|
| Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration | 3.03 ± 0.10 | 1.36 ± 0.11 |
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.
| Score on a scale | Test Mouth Rinse | Chlorhexidine Mouth Rinse (0.12% w/v) | Sterile Water |
|---|---|---|---|
| Plaque Index After 24 Hours of Treatment Administration | 1.33 ± 0.09 | 0.58 ± 0.09 | 1.29 ± 0.09 |
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.
| Score on a scale | Test Mouth Rinse | Chlorhexidine Mouth Rinse (0.12% w/v) | Sterile Water |
|---|---|---|---|
| Interproximal Plaque Index After Day 4 of Treatment Administration | 3.17 ± 0.10 | 1.48 ± 0.11 | 3.36 ± 0.11 |
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.
| Score on a scale | Test Mouth Rinse | Chlorhexidine Mouth Rinse (0.12% w/v) | Sterile Water |
|---|---|---|---|
| Interproximal Plaque Index After 24 Hours of Treatment Administration | 1.60 ± 0.11 | 0.72 ± 0.11 | 1.57 ± 0.11 |
Collected over 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.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Test Mouth Rinse | — | 0/22 (0%) | 1/22 (4.5%) |
| Chlorhexidine Mouth Rinse (0.12% w/v) | — | 0/22 (0%) | 1/22 (4.5%) |
| Sterile Water | — | 0/22 (0%) | 2/22 (9.1%) |
| Event | Test Mouth Rinse | Chlorhexidine Mouth Rinse (0.12% w/v) | Sterile Water |
|---|---|---|---|
| Seasonal AllergyImmune system disorders | 0/22 | 0/22 | 1/22 |
| PharyngitisInfections and infestations | 0/22 | 0/22 | 1/22 |
| Multiple Sclerosis RelapseNervous system disorders | 1/22 | 0/22 | 0/22 |
| Nasal CongestionRespiratory, thoracic and mediastinal disorders | 0/22 | 1/22 | 0/22 |
| Age Continuous(Years) | All Randomized Participants |
|---|---|
| Mean | 41.9 ± 14.62 |
| Sex: Female, Male(Participants) | All Randomized Participants |
|---|---|
| Female | 14 |
| Male | 9 |
| Mean Plaque Index Score(Score on a scale) | All Randomized Participants |
|---|---|
| Mean | 3.01 ± 0.34 |
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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GlaxoSmithKline