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

Study 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.

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

Conditions
-----------------
Edentulous Mouth, Edentulous Jaw

Intervention / Treatment
-----------------
* Procedure: Denture fabrication technique


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simplified protocol<br>The application of a simplified denture fabrication technique will be tested for patients presenting severely resorbed mandibular alveolar bones according to the following steps: Obtainment of maxillary and mandibular casts by using irreversible hydrocolloid in stainless steel stock trays for record bases fabrication. 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. Trial dentures will be evaluated for esthetics and maxillomandibular relationship. Insertion of finished dentures. | Procedure: Denture fabrication technique<br>* Both arm groups are composed by patients present severely resorbed mandibular alveolar bones who will receive complete dentures fabricated by means of a simpler techinique previously proved to be effective. Although for the traditional protocol group a second more complex impression step will be performed in order to evaluate if the simpler approach for this anatomical condition could be safely applied.<br>* Other names: Complete denture fabrication technique;|
| No Intervention: Traditional protocol<br>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: Maxillary and mandibular casts obtained by using irreversible hydrocolloid in stainless steel stock trays for maxillary record base and mandibular custom tray fabrication. Mandibular second impression with border molding using compound and impression rubber in custom tray. Record bases adjustments without facebow transfer. Casts will be mounted in semi-adjustable articulator using standardized measures and artificial teeth will be selected. Trial dentures will be evaluated for esthetics and maxillomandibular relationship. Finished dentures insertion. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral health related quality of life | This outcome will be assessed by means of the brazilian version of Oral Health Impact Profile for Edentulous Patients inventory | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with dentures (assessed by means of two specific questionaries) | This outcome will be assessed by means of two specific questionaries | 6 months | 
| Denture quality (assessed by means of a clinical examination according to a specific form) | This outcome will be 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) | This outcome will be assessed by means of a colorimetric method based on an artificial test food | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
complete denture, quality of life, patient satisfaction