Clinical Trial: Efficacy of Three Experimental Toothpastes to Remove Plaque

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Dose Response of Three Experimental Dentifrices in Plaque Removal in a Single Brushing Model

Brief Summary: The Dose response of three experimental toothpastes (test product 1, test product 2 and test product 3) to remove plaque after a single brushing, compared to a positive control and negative control dentifrice will be evaluated.

Detailed Summary: This will be a single centre, controlled, examiner blind, five treatment, five period, crossover design study in healthy participants. This study will evaluate the dose response of three experimental toothpastes (test product 1, test product 2 and test product 3) to remove plaque after a single brushing, compared to a positive control and negative control dentifrice. Plaque removal efficacy will be measured by Turesky modification of Quigley Hein Plaque Index (TPI).
Sponsor: GlaxoSmithKline

Current Primary Outcome: Change from Pre-brushing to Post-brushing Turesky Modification of Quigley Hein Index (Positive control, versus (vs) Negative control) [ Time Frame: Up to 5 weeks (at every week after single dentifrice use) ]

The dental examiner will use the TPI to assess plaque on all gradable teeth. Plaque will be disclosed using 5 millilitre (mL) of the dye solution (Gum Red Cote), participants will rinse their teeth with dye for 30 seconds and expectorate and then rinse with 10 mL of water for 10 seconds and expectorate again. Plaque will be assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, esiolingual, lingual and distolingual surfaces. Disclosed plaque will be scored as follows for each tooth surface separately: 0 - No plaque, 1 - Slight flecks of plaque at the cervical margin of the tooth, 2 - A thin continuous band of plaque (1 millimeter, 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from Pre-brushing to Post-brushing Turesky Modification of Quigley Hein Index (Test product 1, 2 and 3 vs Negative contol) [ Time Frame: Up to 5 weeks (at every week after single dentifrice use) ]
    The dental examiner will use the TPI to assess plaque on all gradable teeth. Plaque will be disclosed using 5 millilitre (mL) of the dye solution (Gum Red Cote), participants will rinse their teeth with dye for 30 seconds and expectorate and then rinse with 10 mL of water for 10 seconds and expectorate again. Plaque will be assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, esiolingual, lingual and distolingual surfaces. Disclosed plaque will be scored as follows for each tooth surface separately: 0 - No plaque, 1 - Slight flecks of plaque at the cervical margin of the tooth, 2 - A thin continuous band of plaque (1 millimeter, 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.
  • Change from Pre-brushing to Post-brushing Turesky Modification of Quigley Hein Index (Test product 1, 2 and 3 vs Positive control) [ Time Frame: Up to 5 weeks (at every week after single dentifrice use) ]
    The dental examiner will use the TPI to assess plaque on all gradable teeth. Plaque will be disclosed using 5 millilitre (mL) of the dye solution (Gum Red Cote), participants will rinse their teeth with dye for 30 seconds and expectorate and then rinse with 10 mL of water for 10 seconds and expectorate again. Plaque will be assessed with each tooth being divided into 6 areas including the mesiofacial, facial, distofacial, esiolingual, lingual and distolingual surfaces. Disclosed plaque will be scored as follows for each tooth surface separately: 0 - No plaque, 1 - Slight flecks of plaque at the cervical margin of the tooth, 2 - A thin continuous band of plaque (1 millimeter, 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.


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: December 11, 2016
Date Started: December 19, 2016
Date Completion:
Last Updated: May 10, 2017
Last Verified: May 2017