Clinical trial NCT03463174: Cost-effectiveness of the Single-implant Mandibular Overdenture Versus Mandibular Conventional Denture
Official title: A Randomized Controlled Clinical Trial Alongside a Cost-effectiveness Analysis of the Mandibular Conventional Complete Denture Versus Single-implant Mandibular Overdenture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mouth, Edentulous
Complete Edentulism
Keywords: overdenture
edentulism
dental implant
cost-effectiveness
economic analysis
effectiveness
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2018-03-13
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oral health-related quality of life (OHRQoL)
timeFrame: From baseline to 12 months after the intervention
Secondary outcomes:
measure: Satisfaction with the dentures
timeFrame: From baseline to 12 months after the intervention
Other outcomes:
measure: Costs
timeFrame: From denture's fabrication to 12 months after the intervention
Locations:
city: Goiânia
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, Aguiar FMO, Esfandiari S, Leles CR. Effectiveness of immediately loaded single-implant mandibular overdentures versus mandibular complete dentures: A 1-year follow-up of a randomized clinical trial. J Dent. 2018 Oct;77:43-50. doi: 10.1016/j.jdent.2018.07.006. Epub 2018 Jul 10.