Effect of Different Mouthrinses in Plaque Formation
Paraules clau
Resum
Descripció
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).
Dates
| Darrera verificació: | 01/31/2016 |
| Primer enviat: | 02/20/2016 |
| Inscripció estimada enviada: | 02/28/2016 |
| Publicat per primera vegada: | 02/29/2016 |
| Última actualització enviada: | 02/28/2016 |
| Publicació de l'última actualització: | 02/29/2016 |
| Data d'inici de l'estudi real: | 02/29/2016 |
| Data estimada de finalització primària: | 11/30/2016 |
| Data estimada de finalització de l’estudi: | 11/30/2016 |
Condició o malaltia
Intervenció / tractament
Drug: Chlorhexidine gluconate (0,12%)
Drug: M. alternifolia oil (Nanoparticle solution)
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| 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. |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | 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; |
Resultat
Mesures de resultats primaris
1. Dental plaque/biofilm formation. [7 days.]
Mesures de resultats secundaris
1. Gingival abrasion. [7 days.]
Altres mesures de resultats
1. Gingival crevicular fluid- measured through an electronic gingival fluid measuring device (Periotron®) [7 days.]
2. Perception of appreciation- questionnaire [7 days.]
