A Castor Bean Solution for Cleaning Dentures (ACBSFCD)

• ClinicalTrials.gov Identifier: NCT01732744
• Recruitment Status: Completed
• First Posted: November 26, 2012
• Last Update Posted: November 26, 2012
• Sponsor: University of Sao Paulo
• Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Information provided by (Responsible Party): Ingrid Machado de Andrade, University of Sao Paulo

Study Description

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 .

Condition or disease	Intervention/treatment	Phase
Prostheses-related Infections	Other: Physiological solution; Other: Sodium hypochlorite; Other: Alkaline Peroxide; Other: Castor bean solution	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Castor Bean Solution Reduces Complete Denture Biofilm
• Study Start Date: March 2008
• Actual Primary Completion Date: November 2010
• Actual Study Completion Date: May 2011

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 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.	Other: Physiological solution; The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.; Other Name: Saline solution
Active Comparator: 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.	Other: Sodium hypochlorite; The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.; Other Name: 1% Sodium hypochlorite
Active Comparator: Peroxide alkaline; 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.	Other: Alkaline Peroxide; The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.; Other Names: Effervescent tabs; Polident
Experimental: 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.	Other: Castor bean solution; The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.; Other Names: Ricinus communis solution; Castor oil solution

Outcome Measures

Primary Outcome Measures :

1. Denture area covered with biofilm [ Time Frame: 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 .

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

University of Sao Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

• Principal Investigator: Ingrid M Andrade, PhD; University of São Paulo

More Information

• Responsible Party: Ingrid Machado de Andrade, Phd, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT01732744
• Other Study ID Numbers: FORP_491
• First Posted: November 26, 2012
• Last Update Posted: November 26, 2012
• Last Verified: November 2012

Keywords provided by Ingrid Machado de Andrade, University of Sao Paulo:

biofilm, castor bean, sodium hypochlorite, alkaline peroxide

Additional relevant MeSH terms:

Prosthesis-Related Infections; Infection; Postoperative Complications; Pathologic Processes; Sodium Hypochlorite; Eusol; Castor Oil; Pharmaceutical Solutions; Disinfectants; Anti-Infective Agents; Cathartics; Gastrointestinal Agents