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0.12% chlorhexidine mouthrinse

Phase 2

Healthy Subjects | Small molecule | Other |GSK plc|Last Updated: Sep 9, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

0.12% chlorhexidine mouthrinse · 1 trial · 1 indication

Phase 2 1
NCT01122862Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growthHealthy Subjects
COMPLETED23 Analytics
PHASE2COMPLETED
Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

Plaque Index Score of Test Mouth Rinse Versus Chlorhexidine Mouth Rinse After Day 4 of Treatment Administration
Day 4 post treatment administration
Plaque Index After 24 Hours of Treatment Administration
Day 1 post treatment administration
Interproximal Plaque Index After Day 4 of Treatment Administration
Day 4 post treatment administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposePREVENTION

Treatment Arms

ArmTypeDescription
0.12% Chlorhexidine MouthrinseACTIVE_COMPARATORCommercially available 0.12% Chlorhexidine mouthrinse
Cosmetic mouthrinseACTIVE_COMPARATORCommercially available cosmetic mouthrinse
Sterile WaterPLACEBO_COMPARATORSterile Water

Interventions

NameTypeDescription
0.12% chlorhexidine mouthrinseDRUGcommercially available 0.12% chlorhexidine mouthrinse
Cosmetic mouthrinseOTHERCommerically available cosmetic mouthrinse
Sterile waterOTHERSterile water
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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

Countries:United States
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Frequently asked questions about 0.12% chlorhexidine mouthrinse

What is 0.12% chlorhexidine mouthrinse used for?

0.12% chlorhexidine mouthrinse is used for plaque control in healthy subjects. It is being studied in a clinical trial to evaluate its effect on plaque re-growth. The drug is a small molecule and is currently in Phase 2 clinical development.

Who makes 0.12% chlorhexidine mouthrinse?

0.12% chlorhexidine mouthrinse is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to assess the mouthrinse's efficacy in healthy subjects.

What phase is 0.12% chlorhexidine mouthrinse in?

0.12% chlorhexidine mouthrinse is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its effect on plaque re-growth in healthy subjects.

What clinical trials is 0.12% chlorhexidine mouthrinse in?

0.12% chlorhexidine mouthrinse is being studied in one clinical trial, identified as NCT01122862. This Phase 2 trial, titled 'Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth,' has been completed. The trial enrolled 23 healthy subjects in the United States.

Is 0.12% chlorhexidine mouthrinse FDA approved?

0.12% chlorhexidine mouthrinse is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. The drug is being studied for its effect on plaque re-growth in healthy subjects, but it has not yet received regulatory approval.