Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study of an Essential Oil and a Delmopinol Mouthrinse Effect on Dental Plaque Accumulation Index, Gingivitis Index and on Streptococcus Mutans, Lactobacillus, Aerobic and Anaerobic Oral Bacteria Colony Counts.

This study has been completed.
Sponsor:
Collaborator:
Instituto Piaget
Information provided by:
University of Lisbon
ClinicalTrials.gov Identifier:
NCT01236950
First received: November 8, 2010
Last updated: November 9, 2010
Last verified: July 2010

November 8, 2010
November 9, 2010
April 2007
April 2008   (final data collection date for primary outcome measure)
  • Loe & Silness Gingival Index (1963) [ 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 usage.
  • Quigley, Hein & Turesky Dental Plaque Index (1970) [ 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 usage.
  • Loe & Silness Gingival Index (1963) [ 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 usage.
  • Quigley, Hein & Turesky Dental Plaque Index (1970) [ 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 usage.
Complete list of historical versions of study NCT01236950 on ClinicalTrials.gov Archive Site
  • Streptococcus mutans CFU [ Time Frame: change from baseline in CFU counts at two weeks ] [ Designated as safety issue: No ]
    data collected at the begining of the study and two weeks after mouthrinse usage.
  • Lactobacillus CFU [ Time Frame: change from baseline in CFU counts at two weeks ] [ Designated as safety issue: No ]
    data collected at the begining of the study and two weeks after mouthrinse usage.
  • Aerobic and anaerobic oral bacteria CFU [ Time Frame: change from baseline in CFU counts at two weeks ] [ Designated as safety issue: No ]
    data collected at the begining of the study and two weeks after mouthrinse usage.
  • Streptococcus mutans CFU [ 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 usage.
  • Lactobacillus CFU [ 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 usage.
  • Aerobic and anaerobic oral bacteria CFU [ 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 usage.
Not Provided
Not Provided
 
Study of an Essential Oil and a Delmopinol Mouthrinse Effect on Dental Plaque Accumulation Index, Gingivitis Index and on Streptococcus Mutans, Lactobacillus, Aerobic and Anaerobic Oral Bacteria Colony Counts.
Study of an Essential Oil and a Delmopinol Mouthrinse Effect on Dental Plaque Accumulation Index, Gingivitis Index and on Streptococcus Mutans, Lactobacillus, Aerobic and Anaerobic Oral Bacteria Colony Counts.

The use of mouthrinses may be of relevance as a complement to daily dental hygiene procedures, especially for patients who do not comply with a proper mechanical removal of dental plaque. Essential oils and delmopinol mouthrinses are effective to reduce dental plaque accumulation and gingivitis. Also an effect on dental bacteria can be found. The study hypothesis states that there are no differences between the mouthrinses on the reduction of gingivitis and dental plaque accumulation as well on the bacterial counts of Streptococcus mutans, Lactobacillus, aerobic and anaerobic bacteria.

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 indication
    Other Name: Listerine Cool Mint
  • Drug: Delmopinol mouthrinse
    Commercial mouthrinse with manufacturer's use indication
    Other Name: Decapinol
  • Experimental: Delmopinol mouthrinse
    Subjects use the delmopinol mouthrinse
    Intervention: Drug: Delmopinol mouthrinse
  • No Intervention: Control
    Subjects with no use of mouthrinse
  • Experimental: Essential oils mouthrinse
    Subjects using the essential oils mouthrinse
    Intervention: Drug: Essential oils mouthrinse

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
September 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient at the dental hygiene clinic of Faculdade de Medicina Dentária
  • Signature of consent form
  • Have, at least, two quadrant with 6 teeth each
  • Gingival Index at baseline less than 3
  • Presence of dental plaque

Exclusion Criteria:

  • Use of a mouthrinse
  • Dental Hygiene appointment in the past 6 months
  • Use of antibiotics in teh 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
 
NCT01236950
9/2006a
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