search
Back to results

Effect of Different Mouthrinses in Plaque Formation

Primary Purpose

Dental Plaque

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Chlorhexidine gluconate 0.12% (PerioGard®)
Nanoparticle solution of M. alternifolia oil (0.3%).
Sponsored by
Universidade Federal de Santa Maria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Plaque focused on measuring Plaque index, Melaleuca alternifolia oil., Nanoparticles

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Chlorhexidine gluconate (0,12%)

    M. alternifolia oil (Nanoparticle solution)

    Arm Description

    Subjects will rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%).

    Subjects will rinse twice daily with 15 ml mouthrinse containing nanoparticles of M. alternifolia oil (0.3%).

    Outcomes

    Primary Outcome Measures

    Dental plaque/biofilm formation.

    Secondary Outcome Measures

    Gingival abrasion.

    Full Information

    First Posted
    February 21, 2016
    Last Updated
    February 29, 2016
    Sponsor
    Universidade Federal de Santa Maria
    Collaborators
    Centro Universitário Franciscano
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02695901
    Brief Title
    Effect of Different Mouthrinses in Plaque Formation
    Official Title
    Anti-plaque Effect of 0.12% Chlorhexidine Gluconate Rinsing and Nanoparticle Solution of 0.3% Melaleuca Alternifolia: A Randomized Crossover Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal de Santa Maria
    Collaborators
    Centro Universitário Franciscano

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Plaque
    Keywords
    Plaque index, Melaleuca alternifolia oil., Nanoparticles

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    59 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Chlorhexidine gluconate (0,12%)
    Arm Type
    Experimental
    Arm Description
    Subjects will rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%).
    Arm Title
    M. alternifolia oil (Nanoparticle solution)
    Arm Type
    Experimental
    Arm Description
    Subjects will rinse twice daily with 15 ml mouthrinse containing nanoparticles of M. alternifolia oil (0.3%).
    Intervention Type
    Drug
    Intervention Name(s)
    Chlorhexidine gluconate 0.12% (PerioGard®)
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Nanoparticle solution of M. alternifolia oil (0.3%).
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Dental plaque/biofilm formation.
    Time Frame
    7 days.
    Secondary Outcome Measure Information:
    Title
    Gingival abrasion.
    Time Frame
    7 days.
    Other Pre-specified Outcome Measures:
    Title
    Gingival crevicular fluid- measured through an electronic gingival fluid measuring device (Periotron®)
    Description
    The volume of gingival fluid will be measured at two locations per quadrant.
    Time Frame
    7 days.
    Title
    Perception of appreciation- questionnaire
    Description
    Visual Analogue Scale
    Time Frame
    7 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fabricio B. Zanatta, PhD
    Phone
    +55 55 81283358
    Email
    fabriciobzanatta@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fabricio B. Zanatta, PhD
    Organizational Affiliation
    Adjunct Professor
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25395761
    Citation
    Rahman B, Alkawas S, Al Zubaidi EA, Adel OI, Hawas N. Comparative antiplaque and antigingivitis effectiveness of tea tree oil mouthwash and a cetylpyridinium chloride mouthwash: A randomized controlled crossover study. Contemp Clin Dent. 2014 Oct;5(4):466-70. doi: 10.4103/0976-237X.142813.
    Results Reference
    background

    Learn more about this trial

    Effect of Different Mouthrinses in Plaque Formation

    We'll reach out to this number within 24 hrs