Application of a Simplified Method of Complete Denture Fabrication for Severely Resorbed Mandibular Ridges
- Conditions
- Edentulous MouthEdentulous Jaw
- Interventions
- Procedure: Denture fabrication technique
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 72
- complete edentulism for at least one year;
- desire to receive a pair of new conventional complete dentures
- mental receptiveness;
- good understanding of spoken Portuguese
- disorders of the masticatory system;
- pathological changes of residual ridges;
- debilitating systemic diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Simplified protocol Denture fabrication technique The application of a simplified denture fabrication technique will be tested for patients presenting severely resorbed mandibular alveolar bones according to the following steps: 1. Obtainment of maxillary and mandibular casts by using irreversible hydrocolloid in stainless steel stock trays for record bases fabrication. 2. Adjustment of record bases according to vertical dimension and centric relation measurements, with no use of facebow transfer. Casts will be mounted in semi-adjustable articulator using standardized measures and artificial teeth will be selected. 3. Trial dentures will be evaluated for esthetics and maxillomandibular relationship. 4. Insertion of finished dentures.
- 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