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

Phase 3

• Conditions: Edentulous Mouth; Edentulous Jaw

• Registration Number: NCT02339194
• Lead Sponsor: Universidade Federal do Ceara

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-15
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oral health related quality of life	6 months	This outcome will be assessed by means of the brazilian version of Oral Health Impact Profile for Edentulous Patients inventory

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dental School of Federal University of Ceara; 🇧🇷 Fortaleza, Ceara, Brazil