Effect of Different Mouthrinses in Plaque Formation

February 29, 2016 updated by: Maísa Casarin, Universidade Federal de Santa Maria

Anti-plaque Effect of 0.12% Chlorhexidine Gluconate Rinsing and Nanoparticle Solution of 0.3% Melaleuca Alternifolia: A Randomized Crossover Clinical Trial

Although several studies have assessed the efficacy of chlorhexidine in treating gingivitis and reducing biofilm formation, the side effects of a long-term use are unpleasant for patients. Melaleuca alternifolia oil has been considered as an alternative because of its anti-inflammatory properties. However, little is know about the efficacy of its nanoparticles. The purpose of this study is to compare the effect of 0.12% chlorhexidine (Periogard ®) and a nanoparticle solution of 0.3% M. alternifolia oil in reducing biofilm formation in plaque-free and plaque-covered teeth surfaces.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This will be a randomized crossover clinical trial, double blind, in which individuals will be randomly assigned into two different treatments: daily mouthrinse of chlorhexidine gluconate (0.12%) or daily mouthrinse of a nanoparticle solution of M. alternifolia (0.3%) during a period of oral hygiene withdrawal.

The test panel will consist of 59 students from the Federal University of Santa Maria, Santa Maria, Rio Grande do Sul, Brazil. All subjects will receive written and oral explanations regarding the purpose and design of this study. Those who met the inclusion criteria will be selected for a dental screening appointment, being removed in the presence of any exclusion criteria. All volunteers will be asked to sign an informed consent before the experimental period.

The following clinical parameters will be assessed:

  • Plaque index (PI) Quigley and Hein modified by Turesky.
  • Gingival crevicular fluid (GCF) will be measured with an electronic gingival fluid measuring device (Periotron®).
  • Gingival abrasion (GA) using 2-Tone disclosing solution.
  • Perception of appreciation (Questionnaire-VAS scale). Descriptive analysis of PI data will be performed using averages, standard deviations and average percentage of sites with different PI scores. The normal distribution of the data will be evaluated by the Kolmogorov-Smirnov test. Analysis of variance (ANOVA) with repeated measures will be used to test for differences between groups. Paired student's t-test will be conducted to test whether there were significant differences between the baseline measurements of PI, GA, GCF and perception of appreciation after the use of mouthwash. The statistical tests will be performed using the program SPSS 20.0 (Statistical Package for the Social Sciences, Chicago, USA).

Study Type

Interventional

Enrollment (Anticipated)

59

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

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

16 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals must be systemically healthy;
  • Must have at least six teeth per quadrant;
  • Must not be undergoing medical treatment;

Exclusion Criteria:

  • Allergies or hypersensitivity to the components (Chlorhexidine Gluconate or M. alternifolia oil nanoparticles);
  • Antibiotic therapy within 3 months prior to baseline examination;
  • History of periodontal disease;
  • Marginal bleeding index higher than 15%;
  • Oral mucosal lesions;
  • Pregnancy or breastfeeding;
  • Presence of active infectious foci (endodontic abscesses);
  • Presence of plaque retentive factors (caries, aesthetic or ill-fitting restorations, orthodontic appliances, fixed or removable prosthesis);
  • Smokers;
  • Systemic conditions (diabetes, immunosuppression);
  • Use of any mouthwash within 21 days prior to baseline examination;

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: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chlorhexidine gluconate (0,12%)
Subjects will rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%).
Drug: Chlorhexidine gluconate 0.12% (PerioGard®)
At baseline, subjects will receive a professional prophylaxis and will be instructed to withdrawal oral hygiene methods for 3 days. At day 4, 2 contra-lateral quadrants will be randomly chosen to receive a professional prophylaxis, being controls for plaque-covered surfaces. Subjects will then start to rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%). Plaque indices will be recorded at baseline, day 4, and day 7.
Experimental: M. alternifolia oil (Nanoparticle solution)
Subjects will rinse twice daily with 15 ml mouthrinse containing nanoparticles of M. alternifolia oil (0.3%).
Drug: Nanoparticle solution of M. alternifolia oil (0.3%).
At baseline, subjects will receive a professional prophylaxis and will be instructed to withdrawal oral hygiene methods for 3 days. At day 4, 2 contra-lateral quadrants will be randomly chosen to receive a professional prophylaxis, being controls for plaque-covered surfaces. Subjects will then start to rinse twice daily with 15 ml mouthrinse containing a nanoparticle solution of M. alternifolia oil (0.3%). Plaque indices will be recorded at baseline, day 4, and day 7.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dental plaque/biofilm formation.
Time Frame: 7 days.
7 days.

Secondary Outcome Measures

Outcome Measure
Time Frame
Gingival abrasion.
Time Frame: 7 days.
7 days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gingival crevicular fluid- measured through an electronic gingival fluid measuring device (Periotron®)
Time Frame: 7 days.
The volume of gingival fluid will be measured at two locations per quadrant.
7 days.
Perception of appreciation- questionnaire
Time Frame: 7 days.
Visual Analogue Scale
7 days.

Collaborators and Investigators

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

Sponsor

Universidade Federal de Santa Maria

Collaborators

Centro Universitário Franciscano

Investigators

  • Study Director: Fabricio B. Zanatta, PhD, Adjunct Professor

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

March 1, 2016

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 21, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 1, 2016

Study Record Updates

Last Update Posted (Estimate)

March 1, 2016

Last Update Submitted That Met QC Criteria

February 29, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 52275816.0.0000.5346
  • 1.399.643 (Other Identifier: Ethics Committee in Research)

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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