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Evaluation of new toothpaste formulations for total denture cleaning

Evaluation of experimental dentifrices based on essential oils for total prosthesis hygiene - in vitro and in vivo studies

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6kr745
Enrollment
Unknown
Registered
2019-10-28
Start date
2020-01-10
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomatitis Denture

Interventions

100 participants from the FORP / USP Total Prosthesis Discipline clinics will be evaluated during the first and second semesters of 2019 and 2020 following the inclusion criteria. Selected individuals
Other
A20.593

Sponsors

Faculdade de Odontologia de Ribeirâo Preto
Lead Sponsor
Faculdade de Odontologia de Ribeirâo Preto
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria will be: total toothless individuals of any age; both genders; with good overall health;users of superior total dentures for at least one year and with presence of prosthetic stomatitis in the upper arch. As for prostheses must be made with acrylic resin base and artificial teeth and be in good conditions of use, and with the presence of biofilm on the inner surface according to the Additive Index.

Exclusion criteria

Exclusion criteria: Will be excluded individuals who have used antibiotics in the past three months or users of prostheses with products for denture rebasing, repairs or fractures.

Design outcomes

Primary

MeasureTime frame
As a primary endpoint, the reduction of the microbial load of the prostheses and stomatitis remission will be considered. The upper complete dentures will be removed from the oral cavity, rinsed with running water, air-jet dried and stained with 1% neutral red for biofilm evidence. The stained prostheses will then be placed in Petri dishes, in an aseptic zone, for the dissolution of the biofilm with a sterilized brush and PBS (phosphate buffered saline). The obtained solution will be transferred to a test tube with glass beads, with the help of a pipette. For collection of the palate samples, a sterile cytology brush will be rubbed into the palatine regions affected by the prosthesis-related stomatitis, and then the active tip will be sectioned and stored in a sterile tube containing 5 mL of PBS solution. The solutions with the prosthesis samples will be shaken for 1 minute with the aid of a Vortex stirrer and 50 ?l of the solutions will be diluted in 450 ?l in PBS, obtaining serial dilutions of 10 ?l to 10 ?l which will be seeded in Petri dishes with culture medium specific for the growth of Staphylococcus spp., Candida spp. and Streptococcus mutans. Incubation will be performed in a microbiological oven at 37 ° C for 48 hours. The culture of S. mutans will be in a microareophilic environment in anaerobic jar. After the incubation period, the investigator will perform the CFU count to quantify the microbial load. For the calculation of CFU / mL, the dilution in which the number of CFUs will vary between 0 and 300 colonies, using the formula: UFC / mL = number of colonies x 10? / Q; where n is the absolute value of the dilution (0, 1, 2 or 3); q: quantity (mL) pipetted for each dilution at sowing (0.05).

Secondary

MeasureTime frame
As a secondary outcome, remission of denture stomatitis (DS) will be considered. In order to evaluate the effect of hygiene protocols on ERP remission, patients will be evaluated in the Baseline and after the use of protocols. Standardized palate photos (Canon EOS digital camera, Canon EF Macro lens 100mm / 2: 8 and Canon ML3 circular flash), with a focus centered on the medium rafe region, will be performed and analyzed in a computer, where they will receive scores according to the Newton's classification modified. The assignment of the scores will be performed by two researchers (P2 and P4), previously calibrated;The ability to remove the biofilm from the internal surface of the complete dentures will also be considered as a secondary outcome. The denture appliances will be removed from the oral cavity by the researcher, rinsed in running water for five seconds and dried with the air stream from the triple syringe for 10 seconds. The inner surface of the upper complete denture will be stained with a neutral red biofilm at 1% with the aid of a cotton swab for subsequent quantification of the biofilm. The prosthesis will be rinsed again for five seconds, to remove excess of evidence and dry with the air jet for 10 seconds. The prostheses will then be photographed with standard film-object distance and exposure time. Quantification of the total area and area covered with stained biofilm will be performed using Image Tool software (Windows, version 3.0, The University of Texas Health Science Center in San Antonio). To calculate the percentage of the surface covered by the biofilm (x), the ratio of the area of biofilm (stained area) multiplied by 100, by the total area of the inner surface of the prosthesis, will be used. ;After the use of each toothpaste, the participant will answer a questionnaire, aiming to evaluate the acceptance of the product.

Countries

Brazil

Contacts

Public ContactHelena Oliveira Paranhos

Faculdade de Odontologia de Ribeirâo Preto

helenpar@forp.usp.br+55-16-3315-3955

Outcome results

None listed

Source: REBEC (via WHO ICTRP)