Simplified Versus Conventional Technique for Complete Denture Fabrication.

January 7, 2016 updated by: Ana Luísa de Barros Pascoal, Universidade Federal do Rio Grande do Norte

Quality of Life, Patient Satisfaction, Quality of Dentures, Masticatory Efficiency, Presence of Temporomandibular Dysfunction and Costs Analysis of Simplified and Conventional Techniques for Complete Denture Fabrication

The purpose of this study is to evaluate the effectiveness of a simplified technique of conventional dentures fabrication, comparing it to a traditional technique, by evaluating the impact of oral health on quality of life, satisfaction of individuals and chewing efficiency as well assessing the quality of prosthetics and TMD. Furthermore, the cost involved in the manufacture of dentures through technique simplified will be compared to the cost involved in the traditional technique.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The traditional technique will be conducted through a protocol used by most dental schools in Brazil and described in some clinical trials as a conventional technique for dentures fabrication. On simplified technical functional molding step is deleted, and thus the orientation planes are made directly on the resulting models of the initial molding alginate, and the mounting of the models is performed in semiadjustable articulators random with the aid of an auxiliary table 15 degrees with semiadjustable articulators fixed to the slope. To evaluate the impact on oral health quality of life of individuals will be used the Brazilian version of Oral Health Impact Profile for edentulous patients (OHIP-Edent) for evaluation of patient satisfaction will use a specific questionnaire assessing the quality of the prostheses will be carried out through a specific exam, to assess the presence of TMD, all subjects will be evaluated through the RDC / TMD, for assessing the efficiency masticatory chewing capsules are used, the costs involved in the manufacture of prostheses will be calculated according to the material consumption used during the making of the prosthesis. All subjects will be assessed before making the prostheses and 90 days after installation of new dentures during this period will be held regular control visits. The data will be evaluated in order descriptive by numbers and proportions, moreover, it will be statistically evaluated by means of suitable tests.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Edentulous individuals for more than one year and total bimaxillary prosthesis users that need a couple of new prostheses.

Exclusion Criteria:

Pathological changes of alveolar ridges, motor problems and systemic diseases that may influence on the individual's adaptation to the prosthesis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Complete conventional dentures
Complete dentures fabricated by conventional technique.
Device: Complete conventional dentures

The typical operations of conventional technique will be carried out dentures fabrication and clinical appointments and laboratory steps will be necessary until denture insertion:

Preliminary impression using irreversible hydrocolloid in a stock trays; Individual acrylic resin trays fabrication; Functional impressions using Zinc oxide-eugenol paste and low fusion compound in a individual acrylic resin trays; Maxillary occlusion rims fabrication; Maxillary occlusion rims fabrication adjustments, Centric relation records and transference of the maxillary occlusion rims positions to semiadjustable articulators using a facebow; Setting of teeth in wax; Complete denture wax try-in; Insertion, instructions and postinsertion appointments.

Other Names:
  • Complete traditional dentures
Active Comparator: Complete simplified dentures
Complete dentures fabricated by simplified technique
Device: Complete simplified dentures
For a complete simplified denture fabrication, individual acrylic resin trays fabrication and functional impressions steps will be deleted, and the facebow for transference of the maxillary occlusion rims positions to semiadjustable articulators will be replaced by the table Camper.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: Baseline = day 0
To assess the impact of oral health on quality of life individuals will be used the Brazilian version of Oral Health Impact Profile for edentulous patients (OHIP-Edent). The inventory shall be applied by a masked examiner.
Baseline = day 0
Patient satisfaction
Time Frame: Baseline = day 0
Patient satisfaction about complete dentures will be access using a questionnaire that assesses aspects related to overall quality of prosthesis, as well as comfort, aesthetics, retention, phonetics and mastication.
Baseline = day 0
Masticatory efficiency
Time Frame: Three months
The evaluation of the masticatory efficiency will be conducted through chewing capsules.
Three months
Quality of life
Time Frame: Three months
To assess the impact of oral health on quality of life individuals will be used the Brazilian version of Oral Health Impact Profile for edentulous patients (OHIP-Edent). The inventory shall be applied by a masked examiner.
Three months
Patient satisfaction
Time Frame: Three month
Patient satisfaction about complete dentures will be access using a questionnaire that assesses aspects related to overall quality of prosthesis, as well as comfort, aesthetics, retention, phonetics and mastication.
Three month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Costs analysis
Time Frame: Baseline = day 0
Assessment of the costs involved in the dentures fabrication will be calculated according to the methodology applied by Takanashi et al. 2004.
Baseline = day 0
Quality of dentures
Time Frame: Three months
Assessment of the technical quality of dentures will be done using an examination that analyzes 14 variables: Selection of artificial teeth; Arrangement of the anterior teeth; Interocclusal distance; Stability of the upper and lower prosthesis; Language space; Centric occlusion; Occlusion during the excursive movements; Retention of upper and lower dentures; Edge of the upper prosthesis extension; Edge of the lower prosthesis extension; facets; Positioning of the posterior teeth.
Three months
Temporomandibular dysfunction
Time Frame: Baseline = day 0
To evaluate the presence of TMD, all subjects will be assessed through RDC / TMD translated and validated to Portuguese by a masked examiner.
Baseline = day 0
Temporomandibular dysfunction
Time Frame: Three month
To evaluate the presence of TMD, all subjects will be assessed through RDC / TMD translated and validated to Portuguese by a masked examiner.
Three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio Grande do Norte

Investigators

  • Study Director: Patricia dos Santos Calderon, Doctor, Universidade Federal do Rio Grande do Norte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 11, 2016

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Simplified versus conventional

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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