Simplified Versus Conventional Technique for Complete Denture Fabrication.
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
1 other identifier
interventional
42
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2015
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 4, 2016
CompletedFirst Posted
Study publicly available on registry
January 11, 2016
CompletedJanuary 11, 2016
January 1, 2016
9 months
January 4, 2016
January 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Quality of life
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
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
The evaluation of the masticatory efficiency will be conducted through chewing capsules.
Three months
Quality of life
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
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 Outcomes (4)
Costs analysis
Baseline = day 0
Quality of dentures
Three months
Temporomandibular dysfunction
Baseline = day 0
Temporomandibular dysfunction
Three month
Study Arms (2)
Complete conventional dentures
ACTIVE COMPARATORComplete dentures fabricated by conventional technique.
Complete simplified dentures
ACTIVE COMPARATORComplete dentures fabricated by simplified technique
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Edentulous individuals for more than one year and total bimaxillary prosthesis users that need a couple of new prostheses.
You may not qualify if:
- Pathological changes of alveolar ridges, motor problems and systemic diseases that may influence on the individual's adaptation to the prosthesis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Takanashi Y, Penrod JR, Lund JP, Feine JS. A cost comparison of mandibular two-implant overdenture and conventional denture treatment. Int J Prosthodont. 2004 Mar-Apr;17(2):181-6.
PMID: 15119869BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Patricia dos Santos Calderon, Doctor
Universidade Federal do Rio Grande do Norte
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 4, 2016
First Posted
January 11, 2016
Study Start
March 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 11, 2016
Record last verified: 2016-01