Simplified Versus Conventional Technique for Complete Denture Fabrication.

Phase 2

Completed

• Conditions: Edentulous
• Interventions: Device: Complete conventional dentures; Device: Complete simplified dentures

• Registration Number: NCT02652403
• Lead Sponsor: Universidade Federal do Rio Grande do Norte

Brief Summary

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.

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 Timeline

• Study Start: 2015-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-07
• Last Update Submitted: 2016-01-07
• Study First Posted: 2016-01-11
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Complete conventional dentures	Complete conventional dentures	Complete dentures fabricated by conventional technique.
Complete simplified dentures	Complete simplified dentures	Complete dentures fabricated by simplified technique

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	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.
Masticatory efficiency	Three months	The evaluation of the masticatory efficiency will be conducted through chewing capsules.
Quality of life	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.

Secondary Outcome Measures

Name	Time	Method
Costs analysis	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.
Quality of dentures	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.
Temporomandibular dysfunction	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.