A Phase 3 interventional study of Denture fabrication technique in Edentulous Mouth and Edentulous Jaw, sponsored by Universidade Federal do Ceara. Status unknown at 1 site in Brazil. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2015-12-04.
Sponsored by Universidade Federal do Ceara · Phase 3, Interventional, and Health services research
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.
171 studies on the registry are indexed under Jaw, Edentulous; 24 are open to participants now.
This study's planned enrollment of 72 is above the median of 33 across 146 interventional studies indexed under Jaw, Edentulous.
Browse Jaw, Edentulous studies →Universidade Federal do Ceara is the lead sponsor of 21 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Denture fabrication technique
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.
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.
Also known as: Fabrication of complete dentures, Complete denture fabrication technique
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
Time frame: 6 months
Satisfaction with dentures (assessed by means of two specific questionaries)
This outcome will be assessed by means of two specific questionaries
Time frame: 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
Time frame: 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
Time frame: 6 months
This study is status unknown, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Universidade Federal do Ceara