Clinical trial NCT02710357: A Cost-effectiveness Analysis of the Single-implant Mandibular Overdenture Treatment
Official title: Single-implant Mandibular Overdenture or a Conventional Complete Denture? A Cost-effectiveness Analysis Alongside a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mouth, Edentulous
Keywords: Mandibular Prosthesis Implantation
Prostheses and Implants
Denture, Complete, Lower
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
Collaborators: name: ITI International Team for Implantology, Switzerland
First posted: 2016-03-16
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Oral health-related quality of life impacts
timeFrame: Changes from baseline to 12 months after the intervention
measure: Satisfaction with the dentures
timeFrame: Changes from baseline to 12 months after the intervention
Secondary outcomes:
measure: Masticatory efficiency
timeFrame: Changes from baseline to 12 months after the intervention
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: School of Dentistry, Federal University of Goias
state: Goias
Study officials:
affiliation: Universidade Federal de Goias
name: Claudio R Leles, DDS, PhD
role: STUDY_DIRECTOR
References:
citation: Nogueira TE, Esfandiari S, Leles CR. Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial. Trials. 2016 Nov 4;17(1):533. doi: 10.1186/s13063-016-1646-0.