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.

November 9, 2010 updated by: University of Lisbon
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisboa, Portugal, 1649-003
        • Faculdade de Medicina Dentária da Universidade de Lisboa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Delmopinol mouthrinse
Subjects use the delmopinol mouthrinse
Drug: Delmopinol mouthrinse
Commercial mouthrinse with manufacturer's use indication
Other Names:
  • 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 Names:
  • Listerine Cool Mint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loe & Silness Gingival Index (1963)
Time Frame: change from baseline in gingival index at two weeks
data collected at the begining of the study and two weeks after mouthrinse usage.
change from baseline in gingival index at two weeks
Quigley, Hein & Turesky Dental Plaque Index (1970)
Time Frame: change from baseline in plaque index at two weeks
data collected at the begining of the study and two weeks after mouthrinse usage.
change from baseline in plaque index at two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Streptococcus mutans CFU
Time Frame: change from baseline in CFU counts at two weeks
data collected at the begining of the study and two weeks after mouthrinse usage.
change from baseline in CFU counts at two weeks
Lactobacillus CFU
Time Frame: change from baseline in CFU counts at two weeks
data collected at the begining of the study and two weeks after mouthrinse usage.
change from baseline in CFU counts at two weeks
Aerobic and anaerobic oral bacteria CFU
Time Frame: change from baseline in CFU counts at two weeks
data collected at the begining of the study and two weeks after mouthrinse usage.
change from baseline in CFU counts at two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lisbon

Collaborators

Instituto Piaget

Investigators

  • Study Director: Mario F Bernardo, PhD, Faculdade de Medicina Dentária da Universidade de Lisboa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 8, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (Estimate)

November 9, 2010

Study Record Updates

Last Update Posted (Estimate)

November 10, 2010

Last Update Submitted That Met QC Criteria

November 9, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9/2006a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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