Main
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Note: This record shows only 22 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:
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REBEC |
Last refreshed on:
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29 May 2023 |
Main ID: |
RBR-45nf55 |
Date of registration:
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23/04/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Evaluation of the association of removable partial denture supported by implants distal extension.
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Scientific title:
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Evaluation of the remaining alveolar ridge height, the masticatory efficiency and success rate of implants in patients with Kennedy Class I arches rehabilitated with removable partial dentures supported by implants. |
Date of first enrolment:
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15/01/2011 |
Target sample size:
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Recruitment status: |
Not yet recruiting |
URL:
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http://ensaiosclinicos.gov.br/rg/RBR-45nf55 |
Study type:
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Intervention |
Study design:
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Clinical trial, two arms, open, nonrandomized controlled trial.
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Phase:
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N/A
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Adriana da Fonte Porto
Carreiro |
Address:
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avenida Salgado Filho 1787/ Lagoa Nova
59056-000
Natal
Brazil |
Telephone:
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55-(84)-3215-4104 |
Email:
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adrianadafonte@hotmail.com |
Affiliation:
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Universidade Federal do Rio Grande do Norte |
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Name:
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Adriana da Fonte Porto
Carreiro |
Address:
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avenida Salgado Filho 1787/ Lagoa Nova
59056-000
Natal
Brazil |
Telephone:
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55-(84)-3215-4104 |
Email:
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adrianadafonte@hotmail.com |
Affiliation:
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Universidade Federal do Rio Grande do Norte |
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Key inclusion & exclusion criteria
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Inclusion criteria: All patients should have been rehabilitated at the Federal University of Rio Grande do Norte;
Every patient should be bilateral mandibular posterior edentulous;
Every patient should be larger than toothless in order to standardize the sample;
The patient must have a height between the mandibular canal and the alveolar bone margin posterior of at least 7mm.
Exclusion criteria: Will be excluded from the sample patients over 70 years or a weakened state of health;
Diabetic patients;
Patients with osteoporosis;
Patients with periodontal disease, patients not signing the consent form.
Age minimum:
Age maximum:
Gender:
-
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Health Condition(s) or Problem(s) studied
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G07.610.593.260.500
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E06.780.345.760.433.413
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Partially edentulous patients with absence of posterior teeth have less support structures (teeth and oral mucosa) with different degrees of resilience causing difficulties in the prosthetic rehabilitation on the retention, stability and comfort of removable partial dentures.
Removable Partial Denture, Mastication
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Intervention(s)
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D003757
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Procedure/surgery
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The sample will be divided into two groups of thirty patients each: group 1 (control group) whose patients will be rehabilitated with removable partial dentures convencioanl group 2 (treated group, in which patients receive dental implants (implants WAS Neodoent, Curitiba, Brazil ) installed (one on each side in the region of the 2nd molar), the removable partial dentures (RPD) will be adapted for association with these implants. The analysis of adaptation of the prosthesis and masticatory efficiency will be held in three separate stages. The first (T1), immediately after the installation of removable partial dentures (RPDs) in both groups, the second (T2), two months after the use of PRPs for the control group and treated group, the latter still prostheses not be effectively supported on implants (implants will meet in healing period), the third (T3), six months after the use of prostheses in the control group and treated group.
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Primary Outcome(s)
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The evaluation of remaining alveolar ridge height will be made through the base of the saddle removable partial denture, which will serve as a tray, which will put an impression material (polyether) to copy the space between the oral mucosa and the base of the saddle.
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The efficiency analysis is performed by chewing chewing tablets, containing grains fuchsin inside, and when crushed release the substance into the capsule in proportion to the energy used. The chewing efficiency is calculated by measuring, with the aid of a spectrophotometer (Ultrospec 2100 pro UV / Visible Spectrophotometer ®, GE Healthcare, USA) concentration in absorbance (ABS) of the staining intensity of fuchsin solution.
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Secondary Outcome(s)
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The quality of life that is well defined as physical, mental, emotional and psychological, will be assessed through the questionnaire Oral Heath Impact Profile (OHIP-14)
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Source(s) of Monetary Support
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Neodent
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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