Effect of Different Mouthrinses in Plaque Formation
Palabras clave
Abstracto
Descripción
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).
fechas
| Verificado por última vez: | 01/31/2016 |
| Primero enviado: | 02/20/2016 |
| Inscripción estimada enviada: | 02/28/2016 |
| Publicado por primera vez: | 02/29/2016 |
| Última actualización enviada: | 02/28/2016 |
| Última actualización publicada: | 02/29/2016 |
| Fecha de inicio real del estudio: | 02/29/2016 |
| Fecha estimada de finalización primaria: | 11/30/2016 |
| Fecha estimada de finalización del estudio: | 11/30/2016 |
Condición o enfermedad
Intervención / tratamiento
Drug: Chlorhexidine gluconate (0,12%)
Drug: M. alternifolia oil (Nanoparticle solution)
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Chlorhexidine gluconate (0,12%) Subjects will rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%). | Drug: Chlorhexidine gluconate (0,12%) 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: M. alternifolia oil (Nanoparticle solution) 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. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | 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; |
Salir
Medidas de resultado primarias
1. Dental plaque/biofilm formation. [7 days.]
Medidas de resultado secundarias
1. Gingival abrasion. [7 days.]
Otras medidas de resultado
1. Gingival crevicular fluid- measured through an electronic gingival fluid measuring device (Periotron®) [7 days.]
2. Perception of appreciation- questionnaire [7 days.]
