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

Universidade Federal do Ceara

Status and phase: Unknown; Phase 3

Conditions: Edentulous Jaw; Edentulous Mouth

Treatments: Procedure: Denture fabrication technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02339194

136958818

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Simplified protocol

Experimental group

Description:

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.

Treatment:

Procedure: Denture fabrication technique

Traditional protocol

No Intervention group

Description:

The importance of a second impression for denture fabrication technique will be tested for patients presenting severely resorbed mandibular alveolar bones according to the following steps: 1. Maxillary and mandibular casts obtained by using irreversible hydrocolloid in stainless steel stock trays for maxillary record base and mandibular custom tray fabrication. 2. Mandibular second impression with border molding using compound and impression rubber in custom tray. 3. Record bases adjustments without facebow transfer. Casts will be mounted in semi-adjustable articulator using standardized measures and artificial teeth will be selected. 4. Trial dentures will be evaluated for esthetics and maxillomandibular relationship. 5. Finished dentures insertion.