- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01732744
A Castor Bean Solution for Cleaning Dentures (ACBSFCD)
A Castor Bean Solution Reduces Complete Denture Biofilm
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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. |
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:
|
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. |
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:
|
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. |
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:
|
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. |
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 .
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ingrid M Andrade, PhD, University of Sao Paulo
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FORP_491
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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