Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth

Phase 2

Completed

• Conditions: Healthy Subjects
• Interventions: Other: Cosmetic mouthrinse; Other: Sterile water; Drug: 0.12% chlorhexidine mouthrinse

• Registration Number: NCT01122862
• Lead Sponsor: GlaxoSmithKline

Brief Summary

A clinical study to evaluate the effect of a commercial mouth rinse on plaque re-growth

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-13
• Results First Submitted: 2013-05-23
• Status Verified: 2013-07
• Results First Submitted QC: 2013-07-25
• Results First Posted: 2013-07-30
• Last Update Submitted: 2013-08-22
• Last Update Posted: 2013-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cosmetic mouthrinse	Cosmetic mouthrinse	Commercially available cosmetic mouthrinse
Sterile Water	Sterile water	Sterile Water
0.12% Chlorhexidine Mouthrinse	0.12% chlorhexidine mouthrinse	Commercially available 0.12% Chlorhexidine mouthrinse

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Fort Wayne, Indiana, United States