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Clinical Trials/NCT02339194
NCT02339194
Unknown
Phase 3

Application of a Simplified Method of Complete Denture Fabrication for Severely Resorbed Mandibular Ridges

Universidade Federal do Ceara1 site in 1 country72 target enrollmentJanuary 2014

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Edentulous Mouth
Sponsor
Universidade Federal do Ceara
Enrollment
72
Locations
1
Primary Endpoint
Oral health related quality of life
Last Updated
10 years ago

Overview

Brief Summary

BACKGROUND: The literature has shown that simplified methods for complete denture fabrication can be as effective as the traditional techniques, but with less expenditure of time and resources, without prejudice to the patients. However, the effectiveness of these simplified methods for patients with more complex medical conditions haven't been deeply explored.

OBJECTIVES: To evaluate the effectiveness of a proposed simplified method for complete dentures fabrication for patients with severely resorbed mandibular alveolar bones.

METHOD: edentulous patients requesting treatment with bimaxillary complete dentures in a university clinic will be rehabilitated following a simplified technical proposal, being divided randomly into two groups according to the mandibular arch molding technique. In group A, a single impression with alginate through pre-fabricated trays will be performed, while patients allocated in group B will receive a second molding with a more complex technique. After 3 and 6 months, besides important clinical parameters, it will be investigated aspects related to patient's perceptions about the success of treatment. The study will be conducted with a minimum of 30 participants per group, and comparisons between the two groups will be made by means of tests suitable for distribution of data.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
July 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Romulo Rocha Regis

Prof. Dr. Rômulo Rocha Regis

Universidade Federal do Ceara

Eligibility Criteria

Inclusion Criteria

  • complete edentulism for at least one year;
  • desire to receive a pair of new conventional complete dentures
  • mental receptiveness;
  • good understanding of spoken Portuguese

Exclusion Criteria

  • disorders of the masticatory system;
  • pathological changes of residual ridges;
  • debilitating systemic diseases.

Outcomes

Primary Outcomes

Oral health related quality of life

Time Frame: 6 months

This outcome will be assessed by means of the brazilian version of Oral Health Impact Profile for Edentulous Patients inventory

Secondary Outcomes

  • Satisfaction with dentures (assessed by means of two specific questionaries)(6 months)
  • Denture quality (assessed by means of a clinical examination according to a specific form)(3 months)
  • Masticatory performance (assessed by means of a colorimetric method based on an artificial test food)(6 months)

Study Sites (1)

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