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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-8fs5ww
Date of registration: 09/11/2012
Primary sponsor: Universidade Federal do Rio Grande do Norte - Natal, RN, Brazil
Public title: Comparison between two molding techniques in removable partial dentures
Scientific title: A clinical study comparing the technique of forming functional model changed and direct functional impression technique for removable partial dentures free distal end
Date of first enrolment: 26/07/2012
Target sample size: 60
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-8fs5ww/
Study type: 
Study design:  Controlled clinical trial, randomized, double-blind, two-arm, parallel, focusing treatment  
Countries of recruitment
Brazil
Contacts
Name: Kássia  Dias
Address:  avenida Salgado Filho 1787/ Lagoa Nova 59056-000 Natal Brazil
Telephone: 55-(84)-3215-4104
Email: kassiaodonto@hotmail.com
Affiliation:  Universidade Federal do Rio Grande do Norte
Name: Kássia  Dias
Address:  avenida Salgado Filho 1787/ Lagoa Nova 59056-000 Natal Brazil
Telephone: 55-(84)-3215-4104
Email: kassiaodonto@hotmail.com
Affiliation:  Universidade Federal do Rio Grande do Norte
Key inclusion & exclusion criteria
Inclusion criteria: The Patients must have been rehabilitated in the clinic of the Department of Dentistry degree UFRN be carriers of Removable Prosthodontics Total Upper arch and Removable Partial Denture Lower arch with bilateral posterior free end (Kennedy Class I). The minimum age required to participate in the study will be 18 years and included patients of both genders.
Exclusion criteria: Patients with weakened health care unable to attend; patients with normal classification according to bone height that have less than five or more than eight lower teeth

Age minimum: 18
Age maximum: 0
Gender: -
Health Condition(s) or Problem(s) studied
Jaw, Edentulous, Partially
C05.500.480.450
Intervention(s)
Many clinicians question the superiority of molding technique functional model changed about the technique of direct model in partially edentulous arches bilateral later. The sample is comprised of 60 patients with fully edentulous arch maxillary and mandibular Kennedy Class I, of both sexes, with good health overall, rehabilitated in clinical graduate of the Department of Dentistry of the Federal University of Rio Grande do Norte (UFRN), divided into two groups of thirty patients each: group 1 (molding technique functional model changed) and group 2 (direct functional impression technique). The following instruments are used for clinical measures: length of the denture base; presence, amount and location of the areas ulcerated mucosa, adaptation of the denture base, masticatory efficiency, resiliency fibromucous, forms the rim, width and height of the flange and returns amount required for adjustment. The study is double blind because the researcher who will collect the data does not know what kind of impression will be made nor the patients know which group they belong, because patients will be randomized are allocated randomly. The installation shall be accompanied prosthesis, 24 hours, 7, 15, 30, 60 days and six months after installation to the variable fibromucous integrity, ie for the presence of ulcers and perform the necessary adjustments at the base of the prosthesis. Being after network installation, two months and six months for other variables, such as adaptation of the denture base, chewing efficiency and satisfaction. There is no difference between the two study arms regarding the frequency of reviews of the protocol.
Primary Outcome(s)
conclusion -No significant difference was observed between the groups regarding number of occlusal units, mucosa integrity and denture base extension. The altered cast technique did not provide significant improvement in comparison to the direct technique for number of occlusal units, mucosa integrity and denture base extension.

The evaluation of the denture base extension is checked by visual inspection and the necessity of adjusting the edges. It is expected that there is a statistically significant difference between the two techniques employed with respect to the base of the extension prosthesis.It is expected that the changed pattern in the art prosthesis have extensions more appropriate.
The number of points of occlusal contacts will be registered after prosthesis installation. They will be identified and recorded in medical records. Expected to be a difference between the two techniques employed in relation the number of contact points during the installation of dentures
To analyze the integrity of the oral mucosa, we will evaluate the presence or absence of traumatic ulcer. The ulcers develop in one to two days after the installation of new prostheses. It is expected to be a difference between the techniques regarding the integrity of the oral mucosa at different follow-up times
Secondary Outcome(s)
conclusion -No significant difference was observed between the groups regarding quality of life and masticatory efficiency. The altered cast technique did not provide significant improvement in comparison to the direct technique for quality of life and masticatory efficiency.
The analysis of masticatory efficiency is accomplished by mastication of capsules containing grains of fuchsin inside; when crushed, the capsules release fuchsin in proportion to the energy used to masticate. The masticatory efficiency is calculated by measuring, with the aid of a spectrophotometer, concentration in absorbance (ABS) the intensity of staining fuchsin solution. It is expected to be no difference between the two study groups regarding chewing efficiency. The results can be seen from two months of use the new prosthesis
The quality of life is defined as physical wellbeing, mental, psychological and emotional, are assessed by questionnaire Oral Heath Impact Profile (OHIP-14). It is expected to have no difference between the two study groups regarding the impact of oral health on quality of life. The results can be observed from six months of use of the new prostheses
Secondary ID(s)
03054612400005292
60244
Source(s) of Monetary Support
Universidade Federal do Rio Grande do Norte - Natal, RN, Brazil
Secondary Sponsor(s)
Universidade Federal do Rio Grande do Norte - Natal, RN, Brazil
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