Clinical trial NCT03691285: Mandibular Overdenture Retained by 1 or 2 Implants: a Cost-effectiveness Analysis
Official title: Mandibular Overdenture Retained by 1 or 2 Implants: a Cost-effectiveness Analysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edentulous Mouth
Keywords: Overdenture
Dental implant
Cost analysis
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative effectiveness of two competing strategies for the edentulous mandible using implants
Primary purpose: TREATMENT

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.

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: 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
measure: Pain and discomfort
timeFrame: 24 hours, 7 days and 21 days after surgery
measure: Oral health-related quality of life impacts
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:
References: