A Castor Bean Solution for Cleaning Dentures

NCT ID: NCT01732744

Last Updated: 2012-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2011-05-31

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

Conditions

Prostheses-related Infections

Keywords

biofilm, castor bean, sodium hypochlorite, alkaline peroxide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Physiological solution

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Sodium hypochlorite

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Alkaline Peroxide

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Castor bean solution

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Saline solution; 1% Sodium hypochlorite; Effervescent tabs; Polident; Ricinus communis solution; Castor oil 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Ingrid Machado de Andrade

Phd

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ingrid M Andrade, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Other Identifiers

FORP_491

Identifier Type: -

Identifier Source: org_study_id