Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
0.12% chlorhexidine mouthrinse · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 0.12% Chlorhexidine Mouthrinse | ACTIVE_COMPARATOR | Commercially available 0.12% Chlorhexidine mouthrinse |
| Cosmetic mouthrinse | ACTIVE_COMPARATOR | Commercially available cosmetic mouthrinse |
| Sterile Water | PLACEBO_COMPARATOR | Sterile Water |
| Name | Type | Description |
|---|---|---|
| 0.12% chlorhexidine mouthrinse | DRUG | commercially available 0.12% chlorhexidine mouthrinse |
| Cosmetic mouthrinse | OTHER | Commerically available cosmetic mouthrinse |
| Sterile water | OTHER | Sterile water |
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
0.12% chlorhexidine mouthrinse is a small molecule oral rinse developed by GSK plc (ticker GSK). It has been studied in a Phase 2 clinical trial in healthy subjects, evaluating its effect on plaque re-growth. The specific indication for this formulation is undisclosed.
0.12% chlorhexidine mouthrinse is made by GSK plc, which trades under the ticker GSK. GSK is the developer of this formulation and sponsored the clinical trial evaluating its effect on plaque re-growth.
0.12% chlorhexidine mouthrinse is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. The trial enrolled 23 participants and was randomized, placebo-controlled, and conducted in the United States.
0.12% chlorhexidine mouthrinse has been studied in one completed Phase 2 trial, NCT01122862, titled "Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth." The trial enrolled 23 healthy subjects aged 18 years and older in the United States and was randomized and placebo-controlled.
0.12% chlorhexidine mouthrinse has been studied for its effect on plaque re-growth in healthy subjects. The broader therapeutic indication for this formulation is undisclosed. The completed Phase 2 trial evaluated the mouth rinse in a cosmetic context.