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

NCT01122862 | Completed Phase 2 Results

• 1 other identifier: Z36420889
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Keywords

tooth plaque

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Interproximal Plaque Index After 24 Hours of Treatment Administration

  Day 1 post treatment administration

Study Arms (3)

0.12% Chlorhexidine Mouthrinse

ACTIVE COMPARATOR

Commercially available 0.12% Chlorhexidine mouthrinse

Drug: 0.12% chlorhexidine mouthrinse

Cosmetic mouthrinse

ACTIVE COMPARATOR

Commercially available cosmetic mouthrinse

Other: Cosmetic mouthrinse

Sterile Water

PLACEBO COMPARATOR

Sterile Water

Other: Sterile water

Interventions

0.12% chlorhexidine mouthrinse DRUG

commercially available 0.12% chlorhexidine mouthrinse

0.12% Chlorhexidine Mouthrinse

Cosmetic mouthrinse OTHER

Commerically available cosmetic mouthrinse

Cosmetic mouthrinse

Sterile water OTHER

Sterile water

Sterile Water

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 13, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: September 9, 2013
• Results First Posted: July 30, 2013

Record last verified: 2013-07

Locations

US (1)