A Cost-effectiveness Analysis of the Single-implant Mandibular Overdenture

Status Completed

Clinical Trial Summary

The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by a single implant. The study hypothesis is that SIMO is more effective but more costly than the conventional denture, though this incremental cost is relatively low for the offered effectiveness in terms of clinical and patient-reported outcomes.

Clinical Trial Description

This randomized clinical trial alongside a cost-effectiveness analysis will include twenty-eight 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 a Straumann® Standard Plus SLActive® regular neck implant (Straumann 0.33.051S/052S/053S Institute Straumann AG, Basel, Switzerland) in the mandibular midline. 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. 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. ;

Study Design

Related Conditions & MeSH terms

Mouth, Edentulous

Clinical Trial Details

NCT number	NCT02710357
Study type	Interventional
Source	Universidade Federal de Goias
Contact
Status	Completed
Phase	N/A
Start date	March 2016
Completion date	June 2018

View Details

See also
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Recruiting	`NCT00172718` - Using 3.3mm Screw Tap and Cutting Resistance to Evaluate Bone Quality Around Dental Implant	N/A
Completed	`NCT03463174` - Cost-effectiveness of the Single-implant Mandibular Overdenture Versus Mandibular Conventional Denture	N/A
Recruiting	`NCT02775058` - CP009 SYNERGOSS PXX Observational	N/A
Active, not recruiting	`NCT05007691` - Comparative Study of Maxillary and Mandibular Splints Used for the Treatment of Masticatory Muscle Parafunction (FEA)	N/A
Withdrawn	`NCT02521935` - Conventionally vs. Digitally Fabricated Complete Dentures: Clinical Treatment Outcome Differences	N/A
Not yet recruiting	`NCT03391063` - Evaluation of Chewing Efficiency of Conventional Complete Denture in Comparison to Reinforced Poly Amide Denture	N/A
Not yet recruiting	`NCT05667389` - Evaluation of the Vascular and Neural Elements Located in the Symphyseal Region Before Implant Surgery
Terminated	`NCT04023006` - An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures Fabricated by AM
Completed	`NCT01801566` - Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment	N/A
Completed	`NCT01759537` - Study to Evaluate Bone and Gum Dimension Changes Around Dental Implants Placed in Different Positions in Bone.	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Cost-effectiveness Analysis of the Single-implant Mandibular Overdenture Treatment — SIMOECON

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms