A Castor Bean Solution for Cleaning Dentures (ACBSFCD)

University of Sao Paulo

Status: Completed

Conditions: Prostheses-related Infections

Treatments: Other: Sodium hypochlorite; Other: Physiological solution; Other: Alkaline Peroxide; Other: Castor bean solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01732744

FORP_491

Details and patient eligibility

About

To evaluate the efficacy of a castor bean-based solution (Ricinus communis) for removal of complete denture biofilm, comparing it with two products available on the market (sodium hypochlorite and alkaline peroxide). Fifty complete maxillary denture-wearers were instructed to brush their dentures after meals and once a day, for a period of 07 days, immerse them in the following solutions: A - Control: Physiological solution(20 minutes). B - Polident alkaline peroxide(3 minutes). C - 1% sodium hypochlorite(20 minutes). D - castor bean-based solution(20 minutes). The participants immersed their dentures in each of the solutions, according to a randomized sequence. For biofilm quantification, before (Baseline) and after the use of each product, the internal surfaces of maxillary complete dentures were revealed (1% neutral red), photographed and the stained biofilm was quantified with the aid of software (Image Tool 3.0). After concluding measurements of the areas (total and biofilm), the percentage of surface covered by biofilm of the complete denture was calculated .

Full description

The study sought to minimize the occurrence of bias, and whenever possible sought to "blind" the parties involved (researchers, volunteers and statisticians), since none of them had knowledge of the allocation of treatments. The present study also followed the criteria described in the CONSORT Declaration

Enrollment: 50 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients of both genders, age-range 45 years and over, completely edentulous, in a good state of general health, wearers of maxillary complete dentures fabricated of heat polymerized acrylic resin and acrylic artificial teeth.

Exclusion criteria

• Dentures that had been used for less than 03 years, and broken, fractured or relined dentures.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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50 participants in 4 patient groups, including a placebo group

Physiological solution

Placebo Comparator group

Description:

1)Negative Control: physiological solution, for 20 minutes All the volunteers used one of the four chemical methods (interventions) in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure, in order to avoid a carry-over effect.

Treatment:

Other: Physiological solution

Sodium hypochlorite

Active Comparator group

Description:

2)active Comparator 1: Sodium hypochlorite, for 20 minutes All the volunteers used one of the four chemical methods (interventions) in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure, in order to avoid a carry-over effect.

Treatment:

Other: Sodium hypochlorite

Peroxide alkaline

Active Comparator group

Description:

2)Active Comparator 2: Alkaline peroxide (Polident), for 5 minutes All the volunteers used one of the four chemical methods (interventions) in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure, in order to avoid a carry-over effect.

Treatment:

Other: Alkaline Peroxide

Castor bean solution

Experimental group

Description:

3)Experimental: castor bean solution, for 20 minutes All the volunteers used one of the four chemical methods (interventions) in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure, in order to avoid a carry-over effect.

Treatment:

Other: Castor bean solution