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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

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.


Condition or disease Intervention/treatment Phase
Edentulous Mouth Edentulous Jaw Procedure: Denture fabrication technique Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Simplified vs. Conventional Methods for the Fabrication of Complete Dentures in a Public Health Setting
Study Start Date : October 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. Oral health-related quality of life [ Time Frame: 6 months ]
    To be assessed by means of the Brazilian version of the OHIP-EDENT.


Secondary Outcome Measures :
  1. Denture satisfaction [ Time Frame: 6 months ]
    To be assessed by specific questionnaires.

  2. Denture quality [ Time Frame: 3 months ]
    To be assessed by means of clinical exam following a specific form.

  3. Post-insertion adjustments [ Time Frame: 14 days ]
    Necessary post-insertion, as done routinely for conventional denture patients.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01230320


Locations
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Brazil
Ribeirão Preto Dental School
Ribeirão Preto, São Paulo, Brazil, 14040-904
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Raphael F de Souza, DDS, PhD University of Sao Paulo
Additional Information:
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Responsible Party: Raphael Freitas de Souza, Assistant Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01230320    
Other Study ID Numbers: 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) )
First Posted: October 29, 2010    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Keywords provided by Raphael Freitas de Souza, University of Sao Paulo:
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
Additional relevant MeSH terms:
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Jaw, Edentulous
Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Jaw Diseases
Musculoskeletal Diseases