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Simplified vs. Conventional Methods for Complete Denture Fabrication

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ClinicalTrials.gov Identifier: NCT01230320
Recruitment Status : Completed
First Posted : October 29, 2010
Last Update Posted : August 11, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Raphael Freitas de Souza, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE October 27, 2010
First Posted Date  ICMJE October 29, 2010
Last Update Posted Date August 11, 2016
Study Start Date  ICMJE October 2010
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
Oral health-related quality of life [ Time Frame: 6 months ]
To be assessed by means of the Brazilian version of the OHIP-EDENT.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2016)
  • Denture satisfaction [ Time Frame: 6 months ]
    To be assessed by specific questionnaires.
  • Denture quality [ Time Frame: 3 months ]
    To be assessed by means of clinical exam following a specific form.
  • Post-insertion adjustments [ Time Frame: 14 days ]
    Necessary post-insertion, as done routinely for conventional denture patients.
  • Treatment costs [ Time Frame: 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
  • Denture satisfaction [ Time Frame: 6 months ]
    To be assessed by specific questionnaires.
  • Denture quality [ Time Frame: 6 months ]
    To be assessed by means of clinical exam following a specific form.
  • Post-insertion adjustments [ Time Frame: 14 days ]
    Necessary post-insertion, as done routinely for conventional denture patients.
  • Treatment costs [ Time Frame: 6 months ]
    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.
  • Residual ridge resorption (change from baseline) [ Time Frame: 24 months ]
    This measure will be obtained according to 2 methods:
    • Ratios between the area of the posterior residual ridge and a quadrilateral area projected over the edentulous mandible.
    • Ratios between ridge height (both maxillary and mandibular) and reference lines from the lower orbital ridge to the zygomatic processes.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Simplified vs. Conventional Methods for Complete Denture Fabrication
Official Title  ICMJE Simplified vs. Conventional Methods for the Fabrication of Complete Dentures in a Public Health Setting
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:

  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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Edentulous Mouth
  • Edentulous Jaw
Intervention  ICMJE Procedure: Denture fabrication technique

Sequence of procedures involved with the fabrication of conventional complete dentures. Examples of common procedures are:

  1. the reproduction of denture-bearing tissues by means of impression techniques and casts;
  2. the registration of maxillo-mandibular relations;
  3. try-in of artificial teeth and carved denture bases.
Other Names:
  • - Fabrication of complete dentures;
  • - Complete denture fabrication technique.
Study Arms  ICMJE
  • Experimental: Simplified (S) technique

    Complete dentures fabricated according to a simplified technique, divided into the following four sessions:

    1. Maxillary and mandibular casts will be obtained from irreversible hydrocolloid impressions made in stock trays.
    2. 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.
    3. Trial dentures will be evaluated for esthetics and maxillomandibular relationships.
    4. Insertion of finished dentures.
    Intervention: Procedure: Denture fabrication technique
  • Active Comparator: Conventional (C) technique

    Complete dentures fabricated according to a conventional technique:

    1. Initial impression and the obtainment of custom trays;
    2. Final impression with border molding using compound;
    3. Facebow transfer;
    4. Determination of maxillomandibular relationship;
    5. Try-in of anterior teeth;
    6. Try-in of posterior teeth;
    7. Insertion of finished dentures.
    Intervention: Procedure: Denture fabrication technique
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 25, 2012)
40
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2010)
80
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01230320
Other Study ID Numbers  ICMJE FORP-PT-001
2010.1.971.58.0 ( Other Identifier: Institutional Review Board (FORP-USP) )
2010/09381-9 ( Other Grant/Funding Number: FAPESP (São Paulo Research Foundation) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Raphael Freitas de Souza, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Principal Investigator: Raphael F de Souza, DDS, PhD University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP