A Castor Bean Solution for Cleaning Dentures

Not Applicable

Completed

• Conditions: Prostheses-related Infections
• Interventions: Other: Physiological solution; Other: Sodium hypochlorite; Other: Alkaline Peroxide; Other: Castor bean solution

• Registration Number: NCT01732744
• Lead Sponsor: University of Sao Paulo

Brief Summary

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 .

Detailed 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

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2010-11
• Study Completion: 2011-05
• Study First Submitted: 2012-09-26
• Status Verified: 2012-11
• Study First Submitted QC: 2012-11-19
• Last Update Submitted: 2012-11-19
• Study First Posted: 2012-11-26
• Last Update Posted: 2012-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Physiological solution	Physiological solution	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.
Sodium hypochlorite	Sodium hypochlorite	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.
Peroxide alkaline	Alkaline Peroxide	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.
Castor bean solution	Castor bean solution	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.

Primary Outcome Measures

Name	Time	Method
Denture area covered with biofilm	8 weeks	The volunteers were instructed to brush their dentures ,3 times a day and use the following chemical immersion methods, only once a day after dinner: A)Physiological solution .B) 1% Sodium Hypochlorite .C) Polident Alkaline Peroxide .D) 2,0% Castor bean solution . All the volunteers used one of the four chemical methods 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.On the first day and after 07 days of using the interventions, the internal surfaces of dentures were revealed with 1% neutral red solution and photographed with a digital photographic camera. Biofilm was measured on the photographic images of the complete dentures, using the computerized quantitative method "ImageTool". After concluding measurements of the areas (total and biofilm), the percentage of surface covered by biofilm of the complete denture was calculated .