Skip to content

Evaluation of denture cleansers. A clinical trial.

Hygiene protocols for the treatment of Denture-related stomatitis, analysis of local and systemic parameters: a randomized clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4hhwjb
Enrollment
Unknown
Registered
2018-11-09
Start date
2018-09-03
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

Denture-Related Stomatitis

Interventions

The sample will be composed of 100 patients with total dentures with a diagnosis of ERP that will be randomized and allocated in parallel groups according to the different hygiene components: (1) brus
(2) brushing of the palate and immersion of the prosthesis in 0.15% Triclosan solution
(3) The brushing of the palate and the immersion of the citric acid solution and (4) The brushing of the palate and the citric acid in the citric acid solution and the lactose monohydrate. Thus, we in
Other
D01.210.465.800
D02.355.726.900

Sponsors

Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo
Lead Sponsor
Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients can be of both genders; general good health status; bear superior complete dentures in good condition; phosthesis mades in thermally polymerized acrylic resin and acrylic teeth; present regular hygiene habits; present DS pictures between types IB, II or III; a level that is perceptible to severe halitosis and odor of the prosthesis; the prosthesis should present biofilm with a score equal to or greater than 1 according to the Additive Index.

Exclusion criteria

Exclusion criteria: Presenting a prosthesis with problems of adaptation; with relinizations; repairs or fractures; present allergy to any of the products studied; chronic non-controlled diseases; infectious diseases; have used some medicines such as antibiotics, antifungals, immunosuppressants, anticoagulants and steroids during the last 3 months; have used mouthwash solutions in the last 15 days prior to the survey; does not possess enough manual dexterity to perform the hygiene of the prostheses and the cavity; do not understand the Portuguese language; have cognitive problems that may interfere with compliance with the guidelines provided.

Design outcomes

Primary

MeasureTime frame
As a primary endpoint, the reduction of the microbial load of the prostheses and the palate 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 and palate 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., gram negative bacteria, 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).;From each group, 10 participants will be selected who will do the conventional electrocardiogram (12 leads) before and after treatment, and through the electrocardiographic record will be performed the evaluation of heart rate variability (s

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 calibratedd;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. ;Patients' halitosis and prosthesis odor will be assessed by gas chromatography using OralChroma ™ portable device (FIS Inc .. Itami, Japan), capable of measuring the presence of volatile sulfur compounds. With the prosthesis out of the oral cavity

Countries

Brazil

Contacts

Public ContactCláudia Lovato da Silva

Faculdade de Odontologia de Ribeirão Preto - USP

chl@forp.usp.br+55-016-33154006

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 20, 2026