Essential Oils Mouth Rinse and Dental Floss: Efficacy on Interproximal Gingivitis and Dental Plaque Accumulation

May 14, 2024 updated by: Henrique Soares Luis, University of Lisbon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The use of mouthwashes or rinses as an adjunct to mechanical plaque removal should be considered by oral health professionals as part of a strategy to prevent and control patients' oral problems. Most individuals do not brush or floss for the required duration or with the necessary skill to ensure effectiveness, even after receiving hygiene instruction and motivation (Beals et al., 2000; Ciancio, 2003; Santos, 2003). Consequently, inadequate oral hygiene leads to plaque buildup, a key etiological factor in periodontal disease and dental caries. Mouthwashes containing essential oils and rinses with delmopinol have proven effective in controlling plaque development and preventing gingivitis (Baehni and Takeuchi, 2003).

The American Dental Association (ADA) has established guidelines for studying the efficacy of oral hygiene products on gingivitis and plaque accumulation. These guidelines, found in the Acceptance Program Guidelines, provide instructions on planning and evaluating various types of laboratory and clinical studies to test mouthwashes and rinses (ADA, 1997-2008).

In laboratory studies, the effectiveness of antiseptic oral products is tested for their ability to inhibit oral microorganisms. The goal is to determine if these products alter the oral flora. Plaque samples for these studies are collected at baseline and at the end of the experimental period from a predetermined dental surface. Samples are recorded in colony-forming units per millilitre (CFU/ml). For non-specific plaque evaluation, samples are grown on a general nutrient medium, while specific bacteria require selective culture media (ADA, 2008). Bacterial resistance and growth inhibition are assessed using the minimum inhibitory concentration method, typically via the disk diffusion test (ADA, 2008).

Clinical studies, approved by an ethics committee, must demonstrate the efficacy of mouthwashes and rinses in reducing plaque accumulation and gingivitis. Participants undergo a comprehensive oral examination at the study's outset to assess initial conditions, inclusion, and exclusion criteria, and to obtain informed consent (ADA, 1997). Clinical variables are measured at baseline, at study end, and optionally at an intermediate point (ADA, 2006). Sample size must allow for statistical testing with a significance level of 1% or 5% and a power of 80% whenever possible (ADA, 2007). Study duration varies by objective; demonstrating antiseptic properties requires at least six months, while evaluating effects on gingivitis and plaque can be done in as little as two weeks (Collaert et al., 1992-2007).

Participants should be from the product's target population, with usage not necessarily supervised by the researcher. Studies must include both genders and various age groups, with random assignment to experimental and control groups (ADA, 2008). Participants must be healthy adults with no oral pathology and similar oral hygiene conditions, avoiding medications that affect gingival parameters during the study (ADA, 2008). Clinical variables related to plaque and gingivitis are assessed using scientifically recognized indices.

In summary, this study aims to evaluate the effectiveness of mouthwashes and rinses in controlling plaque and gingivitis, following established guidelines to ensure rigorous and systematic assessment.

Study Type

Interventional

Enrollment (Actual)

60

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

Yes

Description

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

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: Essential oils mouthrinse
Subjects use the essential oils mouthrinse
Drug: Essential oils mouthrinse
Commercial mouthrinse with manufacturer's use indications
Other Names:
  • Listerine Cool Mint
Active Comparator: Dental floss
Subjects use dental floss
Device: Dental Floss
Other Names:
  • Colgate Total dental floss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lobene Gingival Index
Time Frame: change from baseline in gingival index at two weeks
data collected at the begining of the study and two weeks after mouthrinse or dental floss use
change from baseline in gingival index at two weeks
Saxton & Ouderaa Bleeding Index
Time Frame: change from baseline in bleeding index at two weeks
data collected at the begining of the study and two weeks after mouthrinse or dental floss use
change from baseline in bleeding index at two weeks
Quigley, Hein & Turesky Dental Plaque Index
Time Frame: change from baseline in plaque index at two weeks
data collected at the begining of the study and two weeks after mouthrinse or dental floss use
change from baseline in plaque index 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

September 1, 2007

Primary Completion (Actual)

January 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 (Estimated)

November 9, 2010

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9/2006b

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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