Mandibular Overdenture Retained by 1 or 2 Implants: a Cost-effectiveness Analysis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Edentulous Mouth
- Sponsor
- Universidade Federal de Goias
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Satisfaction with the dentures
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by one and two implants, based on a randomized clinical trial.
Detailed Description
This randomized clinical trial alongside a cost-effectiveness analysis will include 48 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: mandibular overdenture retained by two implants group or single-implant mandibular overdenture group. Each participant allocated to the single-implant mandibular overdenture group will then receive a Straumann® Standard Plus SLActive® regular neck implant (Straumann 0.33.051S/052S/053S Institute Straumann AG, Basel, Switzerland) in the mandibular midline, and the mandibular overdenture retained by two implants group will receive two implants of the same specification, in the interphoramen region. A healing abutment will be connected and the implant will be allowed to heal for approximately 3 weeks. Then, a 3.4mm retentive titanium anchor abutment (Straumann 048.439, Institute Straumann AG, Basel, Switzerland) will be connected and tightened to 35 N.cm with a torque wrench. The matrix will be incorporated to the denture using self-curing acrylic resin and the patient will be instructed to keep the upper and lower dentures firmly occluded in the habitual position until the final polymerization of the resin. Outcomes (satisfaction with the dentures and oral health-related quality of life) will be measured at baseline and at the 6- and 12-month follow-up. Direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment. Incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. Sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.
Investigators
Cláudio Rodrigues Leles
Associate Professor
Universidade Federal de Goias
Eligibility Criteria
Inclusion Criteria
- •No contraindications for implant surgery (mainly related to uncontrolled systemic diseases)
- •Present enough bone volume in the mandibular midline area for implant placement without the need of bone augmentation procedures.
- •Be able to understand and answer the questionnaires used in the study
- •Agree to participate by providing a written informed consent.
Exclusion Criteria
- •Noncompliant participants
- •Individuals who do not agree to be randomly allocated to the treatment study group
- •Presence of signs of untreated temporomandibular disorders, uncontrolled systemic or oral conditions that require additional treatments
Outcomes
Primary Outcomes
Satisfaction with the dentures
Time Frame: Changes from baseline to 12 months after the intervention
A 100 cm graduated visual analogue scale will be used in order to assess the participants' ratings of their satisfaction with the upper and lower dentures in relation to the parameters "general satisfaction", "comfort", "stability", "aesthetics", "ability to speak" and "ability to chew". Each participant will indicate their level of satisfaction with each parameter by marking a point along the scale, in which ends mean "unsatisfied" and "satisfied", as it is closer to the beginning or the end of the scale, respectively.
Secondary Outcomes
- Pain and discomfort(24 hours, 7 days and 21 days after surgery)
- Oral health-related quality of life impacts(Changes from baseline to 12 months after the intervention)
- Masticatory efficiency(Changes from baseline to 12 months after the intervention)