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
  Purpose

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.


Condition Intervention
Gingivitis
Dental Plaque Accumulation
Drug: Essential oils mouthrinse
Device: Dental Floss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation of an Essential Oils Mouthrinse and Dental Floss.

Resource links provided by NLM:


Further study details as provided by University of Lisbon:

Primary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Essential oils mouthrinse
Subjects use the essential oils mouthrinse
Drug: Essential oils mouthrinse
Commercial mouthrinse with manufacturer's use indications
Other Name: Listerine Cool Mint
Active Comparator: Dental floss
Subjects use dental floss
Device: Dental Floss
Other Name: Colgate Total dental floss

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236963

Locations
Portugal
Faculdade de Medicina Dentária da Universidade de Lisboa
Lisboa, Portugal, 1649-003
Sponsors and Collaborators
University of Lisbon
Instituto Piaget
Investigators
Study Director: Mario F Bernardo, PhD Faculdade de Medicina Dentária da Universidade de Lisboa
  More Information

Publications:
Responsible Party: Henrique Soares Luis, Faculdade de Medicina Dentária da Universidade de Lisboa
ClinicalTrials.gov Identifier: NCT01236963     History of Changes
Other Study ID Numbers: 9/2006b
Study First Received: November 8, 2010
Last Updated: November 9, 2010
Health Authority: Portugal: Health Ethic Committee

Keywords provided by University of Lisbon:
Clinical trial
Prevention mouthrinse
Dental Floss

Additional relevant MeSH terms:
Dental Plaque
Gingivitis
Dental Deposits
Tooth Diseases
Stomatognathic Diseases
Gingival Diseases
Periodontal Diseases
Mouth Diseases

ClinicalTrials.gov processed this record on July 23, 2014