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

A Clinical Study to Evaluate the Effect of a Commercial Cosmetic Mouth Rinse on Plaque Re-growth

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: Sterile water; Drug: 0.12% chlorhexidine mouthrinse; Other: Cosmetic mouthrinse

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46825
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 0.12% Chlorhexidine Mouthrinse; Commercially available 0.12% Chlorhexidine mouthrinse	Drug: 0.12% chlorhexidine mouthrinse; commercially available 0.12% chlorhexidine mouthrinse
ACTIVE_COMPARATOR: Cosmetic mouthrinse; Commercially available cosmetic mouthrinse	Other: Cosmetic mouthrinse; Commerically available cosmetic mouthrinse
PLACEBO_COMPARATOR: Sterile Water	Other: Sterile water; Sterile water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (ACTUAL): May 1, 2010
• Study Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: May 11, 2010
• First Submitted That Met QC Criteria: May 11, 2010
• First Posted (ESTIMATE): May 13, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): September 9, 2013
• Last Update Submitted That Met QC Criteria: August 22, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: tooth plaque
• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: Z36420889