Clinical Trial: Antiplaque/Antigingivitis Efficacy of Essential Oil Mouthrinses in Six-Month Study

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

Official Title: Determination of the Antiplaque/Antigingivitis Efficacy of Essential Oil Containing Mouthrinses In a Six-Month Study

Brief Summary: The objective of this randomized, single-center, examiner-blind, controlled, parallel group, six-month clinical study is to compare the antiplaque/antigingivitis potential of a no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing mouthrinse. A negative control group using only an ADA Accepted anticavity toothpaste will be included.

Detailed Summary:
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide

Current Primary Outcome: Mean Modified Gingival Index (MGI) at 6 Months [ Time Frame: 6 Months ]

Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mean Modified Gingival Index (MGI) at 1 Month [ Time Frame: 1 Month ]
    Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.
  • Mean Modified Gingival Index (MGI) at 3 Months [ Time Frame: 3 Months ]
    Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.
  • Mean Gingival Bleeding Index (BI) at 1 Month [ Time Frame: 1 Month ]
    Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.
  • Mean Gingival Bleeding Index (BI) at 3 Months [ Time Frame: 3 Months ]
    Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.
  • Mean Gingival Bleeding Index (BI) at 6 Months [ Time Frame: 6 Months ]
    Gingival bleeding was assessed at four gingival areas (distobuccal, mid-buccal, mid-lingual, and mesiolingual) around each tooth on a 3-grade categorical scale of 0=absence of bleeding after 30 seconds, 1=bleeding after 30 seconds, and 2=immediate bleeding.
  • Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 1 Month [ Time Frame: 1 Month ]
    Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.
  • Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 3 Months [ Time Frame: 3 Months ]
    Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.
  • Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 6 Months [ Time Frame: 6 Months ]
    Plaque area was scored on six surfaces (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual, and mesiolingual) of all scorable teeth on a 6-grade categorical scale of 0=no plaque to 5=plaque covering 2/3 or more of the surface.


Original Secondary Outcome: Same as current

Information By: Johnson & Johnson Consumer and Personal Products Worldwide

Dates:
Date Received: November 30, 2016
Date Started: September 2013
Date Completion:
Last Updated: November 30, 2016
Last Verified: November 2016