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Essential Oils Mouthrinse and Dental Floss, Comparison of Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation

This study has been completed.
Sponsor:
Collaborator:
Instituto Piaget
Information provided by:
University of Lisbon
ClinicalTrials.gov Identifier:
NCT01236963
First received: November 8, 2010
Last updated: November 9, 2010
Last verified: July 2010

November 8, 2010
November 9, 2010
September 2007
January 2008   (final data collection date for primary outcome measure)
  • Lobene Gingival Index [ Time Frame: change from baseline in gingival index at two weeks ] [ Designated as safety issue: No ]
    data collected at the begining of the study and two weeks after mouthrinse or dental floss use
  • Saxton & Ouderaa Bleeding Index [ Time Frame: change from baseline in bleeding index at two weeks ] [ Designated as safety issue: No ]
    data collected at the begining of the study and two weeks after mouthrinse or dental floss use
  • Quigley, Hein & Turesky Dental Plaque Index [ Time Frame: change from baseline in plaque index at two weeks ] [ Designated as safety issue: No ]
    data collected at the begining of the study and two weeks after mouthrinse or dental floss use
  • Lobene Gingival Index [ Time Frame: before and two weeks after intervention ] [ Designated as safety issue: No ]
    data collected at the begining of the study and two weeks after mouthrinse or dental floss use
  • Saxton & Ouderaa Bleeding Index [ Time Frame: before and two weeks after intervention ] [ Designated as safety issue: No ]
    data collected at the begining of the study and two weeks after mouthrinse or dental floss use
  • Quigley, Hein & Turesky Dental Plaque Index [ Time Frame: before and two weeks after intervention ] [ Designated as safety issue: No ]
    data collected at the begining of the study and two weeks after mouthrinse or dental floss use
Complete list of historical versions of study NCT01236963 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Essential Oils Mouthrinse and Dental Floss, Comparison of Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation
Comparison of Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation of an Essential Oils Mouthrinse and Dental Floss.

It is difficult to obtain patient's compliance with regular interproximal dental hygiene. Dental floss is recognized as an effective procedure to remove dental plaque and prevent gingivitis in the space between teeth, but it is difficult to use and most patients do no do it regularly. Essential oils mouthrinse acts on dental plaque bacteria and helps on gingivitis prevention. These properties may be of interest to control dental plaque accumulation and gingivitis in interproximal areas. The study hypothesis states that there are no differences between the use of an essential oils mouthrinse and dental floss on the reduction of dental plaque accumulation and gingivitis.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Gingivitis
  • Dental Plaque Accumulation
  • Drug: Essential oils mouthrinse
    Commercial mouthrinse with manufacturer's use indications
    Other Name: Listerine Cool Mint
  • Device: Dental Floss
    Other Name: Colgate Total dental floss
  • Experimental: Essential oils mouthrinse
    Subjects use the essential oils mouthrinse
    Intervention: Drug: Essential oils mouthrinse
  • Active Comparator: Dental floss
    Subjects use dental floss
    Intervention: Device: Dental Floss

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2008
January 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • To be a student at the Dental Hygiene programme at the Lisbon Dental School
  • Signature on informed consent form
  • Have, at least, two quadrant with 6 teeth each
  • Presence of dental plaque

Exclusion Criteria:

  • Use of a mouthrinse
  • Dental hygiene appointment in the past 6 months
  • Use of antibiotics in the past 3 months
  • Presence of extensive caries and fractures of teeth
Both
15 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT01236963
9/2006b
No
Henrique Soares Luis, Faculdade de Medicina Dentária da Universidade de Lisboa
University of Lisbon
Instituto Piaget
Study Director: Mario F Bernardo, PhD Faculdade de Medicina Dentária da Universidade de Lisboa
University of Lisbon
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP