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
About this trial
This is an interventional prevention trial for Dental Plaque focused on measuring Plaque index, Melaleuca alternifolia oil., Nanoparticles
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;
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
NCT ID
NCT02695901
First Posted
February 21, 2016
Last Updated
February 29, 2016
Sponsor
Universidade Federal de Santa Maria
Collaborators
Centro Universitário Franciscano
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
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Effect of Different Mouthrinses in Plaque Formation
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