Simplified vs. Conventional Methods for Complete Denture Fabrication

Edentulous Jaw Clinical Trial

Official title:

Simplified vs. Conventional Methods for the Fabrication of Complete Dentures in a Public Health Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01230320
• Other study ID #: FORP-PT-001
• Secondary ID: 2010.1.971.58.02
• Status: Completed
• Phase: N/A
• First received: October 27, 2010
• Last updated: August 9, 2016
• Start date: October 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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:

1. Improve access of the edentulous patients to complete denture treatment by lowering costs and complexity;

2. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Edentulous Jaw
• Edentulous Mouth
• Jaw, Edentulous
• Mouth, Edentulous

Intervention

Procedure:
• Denture fabrication technique
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.

Locations

Country	Name	City	State
Brazil	Ribeirão Preto Dental School	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral health-related quality of life	To be assessed by means of the Brazilian version of the OHIP-EDENT.	6 months	No
Secondary	Denture satisfaction	To be assessed by specific questionnaires.	6 months	No
Secondary	Denture quality	To be assessed by means of clinical exam following a specific form.	3 months	No
Secondary	Post-insertion adjustments	Necessary post-insertion, as done routinely for conventional denture patients.	14 days	No
Secondary	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.	6 months	No

External Links

•   Institutional page of the Ribeirão Preto Dental School (research site)
•   Principal Investigator´s CV