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Simplified vs. Conventional Methods for Complete Denture Fabrication

Primary Purpose

Edentulous Mouth, Edentulous Jaw

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Denture fabrication technique
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Edentulous Mouth focused on measuring Cost estimates, Complete Denture, Dental Economics, Dental Impression Technique, Denture Retention, Edentulous, Edentulism, Oral Health-Related Quality of Life, Patient Acceptance of Health Care, Patient Satisfaction, Quality of Health Care, Quality of Life

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completely edentulous for at least 1 year
  • Patients requesting new maxillary and mandibular complete dentures
  • Mental receptiveness
  • Good understanding of spoken Portuguese

Exclusion Criteria:

  • Debilitating systemic diseases
  • Pathologic changes of residual edentulous ridges
  • Dysfunctional disorders of the masticatory system

Sites / Locations

  • Ribeirão Preto Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Simplified (S) technique

Conventional (C) technique

Arm Description

Complete dentures fabricated according to a simplified technique, divided into the following four sessions: Maxillary and mandibular casts will be obtained from irreversible hydrocolloid impressions made in stock trays. Record bases will be adjusted according to vertical dimension and centric relation measurements, without facebow transfer. Casts will be mounted in a semi-adjustable articulator using standardized measures and artificial teeth will be selected. Trial dentures will be evaluated for esthetics and maxillomandibular relationships. Insertion of finished dentures.

Complete dentures fabricated according to a conventional technique: Initial impression and the obtainment of custom trays; Final impression with border molding using compound; Facebow transfer; Determination of maxillomandibular relationship; Try-in of anterior teeth; Try-in of posterior teeth; Insertion of finished dentures.

Outcomes

Primary Outcome Measures

Oral health-related quality of life
To be assessed by means of the Brazilian version of the OHIP-EDENT.

Secondary Outcome Measures

Denture satisfaction
To be assessed by specific questionnaires.
Denture quality
To be assessed by means of clinical exam following a specific form.
Post-insertion adjustments
Necessary post-insertion, as done routinely for conventional denture patients.
Treatment costs
This outcome will be measured by means of specific forms, according to 2 components: Direct costs: cost of labor, materials, radiographs and medications; Indirect costs: patient's time and transportation expenses.

Full Information

First Posted
October 27, 2010
Last Updated
August 9, 2016
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01230320
Brief Title
Simplified vs. Conventional Methods for Complete Denture Fabrication
Official Title
Simplified vs. Conventional Methods for the Fabrication of Complete Dentures in a Public Health Setting
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
BACKGROUND: The fabrication of complete dentures traditionally involves a series of complex technical procedures. Those procedures include two impressions for each jaw, the registration of the relationship between the upper teeth and the patient's head and usually two appointments for tooth try-in. However, recent studies have questioned the real need for such complex procedures. Simplified methods could have similar results if compared with conventional ones, and dentures would be delivered faster and with lower costs. OBJECTIVES: This study aims to compare the effectiveness complete dentures fabricated with a simplified or conventional method. METHODS: Eighty edentulous patients who requested treatment by maxillary and mandibular complete denture in a public dental clinic inside the University of Sao Paulo - Ribeirão Preto Dental School will be randomly divided into two groups. Group S will receive new dentures fabricated by a simplified method, whereas Group C will received new dentures according to a conventional method. Participants will complete a questionnaire for denture satisfaction and the oral health-related quality of life, 3 and 6 months after treatment. At the same time, a specialist in dental prostheses will evaluate the quality of new dentures.
Detailed Description
Complete edentulism can be considered as an important public health problem, particularly in the elderly. The prevalence of edentulism among adults aged 65 or more years is still high in several countries, such as Canada (58%), Saudi Arabia (31-46%), United Kingdom (46%), China (11%) and India (19%). Normative needs of maxillary and mandibular complete dentures in Brazilian elders were estimated to be 16% and 24%, respectively. This way, the epidemiologic aspect reinforces the need for cost-effective methods when treating patients with complete dentures. The conventional methods for fabrication of complete dentures demand a comprehensive sequence of clinical and laboratorial procedures. Those methods seem to be accepted and taught by most of the American and Brazilian dental schools. However, it has been argued whether they are necessary for the obtainment of adequate dentures. Several approaches were described in attempt to simplify clinical and laboratorial stages, i.e. the fabrication of denture bases directly on casts obtained from irreversible hydrocolloid impressions made in stock trays. Other simplified approaches include the fabrication without facebow transfer, alternative occlusal schemes (i.e. lingualized occlusion) and duplication techniques. A few recent randomized clinical trials have provided some high level evidence about the efficacy of simplified methods. We ran the following search strategy for PubMed at October 2010: (overdenture or ((removable or complete) and denture)) and ((techni* or fabricat* or simpl* or tradition*) or (impression* or occlus* or (facebow or face-bow) or remount* or adjust*)) and (((randomized controlled trial [pt]) OR (controlled clinical trial [pt]) OR (randomized [tiab]) OR (placebo [tiab]) OR (drug therapy [sh]) OR (randomly [tiab]) OR (trial [tiab]) OR (groups [tiab])) AND (humans [mh])) After reading the 470 titles and abstracts, and examining possible reports of randomized clinical trials, only two studies that attempted to evaluate simplified methods for denture fabrication were found. One of the studies compared a simplified and a conventional method for complete denture fabrication by a parallel arms trial. The difference between the methods was the use of a second impression, facebow transfer and remount by the conventional approach. No significant difference between the groups was found for the outcome variables tested - denture quality and patient satisfaction. The other trial compared the relative efficacy of complete dentures fabricated according to two occlusal concepts, by means of a crossover design. A more complex method employed a facebow transfer with recordings of condylar inclination, gothic arch tracing and bilateral balanced occlusion. The simplified technique used no facebow transfer, manual technique for the record of centric occlusion and canine guidance. Denture satisfaction was not influenced by the fabrication method. The current evidence raises doubt about the relevance of some procedures involved in the fabrication of complete dentures. Despite the high quality of the previously cited trials, further studies could use a more pragmatically approach such as testing methods in public health patients. Moreover, data from additional studies could be summarized in the future by means of meta-analysis and thus evidence would be stronger. In summary, such studies may provide support to either: Improve access of the edentulous patients to complete denture treatment by lowering costs and complexity; Reinforce the importance of technical procedures during denture fabrication. OBJECTIVES To compare complete dentures fabricated with a simplified technique and conventional prostheses for the rehabilitation of edentulous patients, after 3 and 6 months of wearing. The null hypothesis will be that mean values of oral health-related quality of life for pairs of dentures fabricated by the simplified and the conventional dentures are similar. Similar secondary hypotheses will be considered for the secondary variables.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Mouth, Edentulous Jaw
Keywords
Cost estimates, Complete Denture, Dental Economics, Dental Impression Technique, Denture Retention, Edentulous, Edentulism, Oral Health-Related Quality of Life, Patient Acceptance of Health Care, Patient Satisfaction, Quality of Health Care, Quality of Life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simplified (S) technique
Arm Type
Experimental
Arm Description
Complete dentures fabricated according to a simplified technique, divided into the following four sessions: Maxillary and mandibular casts will be obtained from irreversible hydrocolloid impressions made in stock trays. Record bases will be adjusted according to vertical dimension and centric relation measurements, without facebow transfer. Casts will be mounted in a semi-adjustable articulator using standardized measures and artificial teeth will be selected. Trial dentures will be evaluated for esthetics and maxillomandibular relationships. Insertion of finished dentures.
Arm Title
Conventional (C) technique
Arm Type
Active Comparator
Arm Description
Complete dentures fabricated according to a conventional technique: Initial impression and the obtainment of custom trays; Final impression with border molding using compound; Facebow transfer; Determination of maxillomandibular relationship; Try-in of anterior teeth; Try-in of posterior teeth; Insertion of finished dentures.
Intervention Type
Procedure
Intervention Name(s)
Denture fabrication technique
Other Intervention Name(s)
- Fabrication of complete dentures;, - Complete denture fabrication technique.
Intervention Description
Sequence of procedures involved with the fabrication of conventional complete dentures. Examples of common procedures are: the reproduction of denture-bearing tissues by means of impression techniques and casts; the registration of maxillo-mandibular relations; try-in of artificial teeth and carved denture bases.
Primary Outcome Measure Information:
Title
Oral health-related quality of life
Description
To be assessed by means of the Brazilian version of the OHIP-EDENT.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Denture satisfaction
Description
To be assessed by specific questionnaires.
Time Frame
6 months
Title
Denture quality
Description
To be assessed by means of clinical exam following a specific form.
Time Frame
3 months
Title
Post-insertion adjustments
Description
Necessary post-insertion, as done routinely for conventional denture patients.
Time Frame
14 days
Title
Treatment costs
Description
This outcome will be measured by means of specific forms, according to 2 components: Direct costs: cost of labor, materials, radiographs and medications; Indirect costs: patient's time and transportation expenses.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completely edentulous for at least 1 year Patients requesting new maxillary and mandibular complete dentures Mental receptiveness Good understanding of spoken Portuguese Exclusion Criteria: Debilitating systemic diseases Pathologic changes of residual edentulous ridges Dysfunctional disorders of the masticatory system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael F de Souza, DDS, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ribeirão Preto Dental School
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14040-904
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.forp.usp.br
Description
Institutional page of the Ribeirão Preto Dental School (research site)
URL
http://sistemas3.usp.br/tycho/CurriculoLattesMostrar?codpub=F7A61880194F
Description
Principal Investigator´s CV

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Simplified vs. Conventional Methods for Complete Denture Fabrication

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