Complete Edentulism, Mouth, Edentulous
Conditions
Keywords
overdenture, edentulism, dental implant, cost-effectiveness, economic analysis, effectiveness
Brief summary
This is a randomized clinical trial designed to assess the 1-year effectiveness of two treatment modalities for the mandibular edentulists: conventional complete dentures and single-implant mandibular overdenture.
Detailed description
This randomized clinical trial alongside a cost-effectiveness analysis will include edentulous individuals who meet eligibility criteria. New maxillary and mandibular dentures will be fabricated for all participants following a standardized protocol. Then, participants will be randomized into one of the treatment groups: conventional complete denture group or single-implant mandibular overdenture group. Each participant allocated to the overdenture group will then receive an implant (Titamax TI cortical - Neodent, Brazil) in the mandibular midline followed by the immediate connection of an O-Ring/ball attachment with intra-oral incorporation of the retention system in the mandibular denture. Direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment and patient-reported outcomes will be assessed. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. A Markov decision tree will be constructed to set out the consequences of the competing alternatives. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.
Interventions
PROCEDUREMandibular overdenture
Placement of an implant in the mandibular midline.
No intervention.
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Universidade Federal de Goias
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* To present favorable general health and the need to be rehabilitated with a new set of complete dentures * To agree to be randomly assigned to one of the two study groups * To be able to comprehend and answer the data collection instruments.
Exclusion criteria
* Presence of general health conditions that may contraindicate implant surgery (such as uncontrolled type II diabetes mellitus or uncontrolled cardiovascular conditions) * Insufficient height and volume in the midline region to receive an implant of at least 3.75mm x 9.0mm * Presence of evident signs of cognitive impairment and/or oral conditions requiring additional treatments, such as oral lesions and temporomandibular disorders * Inability to attend to the scheduled appointments and follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral health-related quality of life (OHRQoL) | From baseline to 12 months after the intervention | The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with the dentures | From baseline to 12 months after the intervention | Participants will report how satisfied they are on a 0-100 scale by choosing a multiple of 10. Zero will be considered the least satisfied possible and 100 the most satisfied possible. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Costs | From denture's fabrication to 12 months after the intervention | All the direct dental costs related to the clinical and laboratory phases of both treatment groups will be listed, measured and valued. |
Countries
Brazil
Outcome results
None listed