Effect of Different Mouthrinses in Plaque Formation

U

Universidade Federal de Santa Maria

Status and phase

Unknown
Phase 4

Conditions

Dental Plaque

Treatments

Drug: Chlorhexidine gluconate 0.12% (PerioGard®)
Drug: Nanoparticle solution of M. alternifolia oil (0.3%).

Study type

Interventional

Funder types

Other

Identifiers

NCT02695901
52275816.0.0000.5346
1.399.643 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment

59 estimated patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts 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;

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

59 participants in 2 patient groups

Chlorhexidine gluconate (0,12%)
Experimental group
Description:
Subjects will rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%).
Treatment:
Drug: Chlorhexidine gluconate 0.12% (PerioGard®)
M. alternifolia oil (Nanoparticle solution)
Experimental group
Description:
Subjects will rinse twice daily with 15 ml mouthrinse containing nanoparticles of M. alternifolia oil (0.3%).
Treatment:
Drug: Nanoparticle solution of M. alternifolia oil (0.3%).

Trial contacts and locations

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Central trial contact

Fabricio B. Zanatta, PhD

Data sourced from clinicaltrials.gov

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