Edentulous Jaw, Edentulous Mouth
Conditions
Keywords
complete denture, quality of life, patient satisfaction
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.
Interventions
PROCEDUREDenture fabrication technique
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.
Sponsors
Fundação Cearense de Apoio ao Desenvolvimento Científico e Tecnológico
Universidade Federal do Ceara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Brazil
Contacts
Primary ContactSamara M Sales, DDS
Outcome results
None listed