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
  Purpose

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.


Condition Intervention
Gingivitis
Dental Plaque Accumulation
Drug: Essential oils mouthrinse
Drug: Delmopinol mouthrinse

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Further study details as provided by University of Lisbon:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 90
Study Start Date: April 2007
Study Completion Date: September 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Delmopinol mouthrinse
Subjects use the delmopinol mouthrinse
Drug: Delmopinol mouthrinse
Commercial mouthrinse with manufacturer's use indication
Other Name: Decapinol
No Intervention: Control
Subjects with no use of mouthrinse
Experimental: Essential oils mouthrinse
Subjects using the essential oils mouthrinse
Drug: Essential oils mouthrinse
Commercial mouthrinse with manufacturer's use indication
Other Name: Listerine Cool Mint

  Eligibility

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

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
  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: NCT01236950

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: NCT01236950     History of Changes
Other Study ID Numbers: 9/2006a
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

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

ClinicalTrials.gov processed this record on September 30, 2014