A Castor Bean Solution for Cleaning Dentures

A Castor Bean Solution Reduces Complete Denture Biofilm

Sponsors

Lead Sponsor: University of Sao Paulo

Collaborator: Fundação de Amparo à Pesquisa do Estado de São Paulo

Source 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

Overall Status Completed
Start Date 2008-03-01
Completion Date 2011-05-01
Primary Completion Date 2010-11-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Denture area covered with biofilm 8 weeks
Enrollment 50
Condition
Intervention

Intervention Type: Other

Intervention Name: Physiological solution

Description: 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.

Arm Group Label: Physiological solution

Other Name: Saline solution

Intervention Type: Other

Intervention Name: Sodium hypochlorite

Description: 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.

Arm Group Label: Sodium hypochlorite

Other Name: 1% Sodium hypochlorite

Intervention Type: Other

Intervention Name: Alkaline Peroxide

Description: 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.

Arm Group Label: Peroxide alkaline

Intervention Type: Other

Intervention Name: Castor bean solution

Description: 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.

Arm Group Label: Castor bean solution

Eligibility

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.

Gender:

All

Minimum Age:

45 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Ingrid M Andrade, PhD Principal Investigator University of São Paulo
Verification Date

2012-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Sao Paulo

Investigator Full Name: Ingrid Machado de Andrade

Investigator Title: Phd

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Physiological solution

Type: Placebo Comparator

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.

Label: Sodium hypochlorite

Type: Active Comparator

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.

Label: Peroxide alkaline

Type: Active Comparator

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.

Label: Castor bean solution

Type: Experimental

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.

Acronym ACBSFCD
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

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