A Cost-effectiveness Analysis of the Single-implant Mandibular Overdenture Treatment
SIMOECON
Single-implant Mandibular Overdenture or a Conventional Complete Denture? A Cost-effectiveness Analysis Alongside a Randomized Clinical Trial
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 11, 2016
CompletedFirst Posted
Study publicly available on registry
March 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedSeptember 18, 2018
September 1, 2018
2 years
March 11, 2016
September 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Oral health-related quality of life impacts
The cross-culturally adapted Brazilian version of the Oral Health Impact Profile for edentulous subjects (OHIP-EDENT) will be used. It contains 19 items divided in four different subscale domains: (I) masticatory discomfort and disability (four items), (II) psychological discomfort and disability (five items), (III) social disability (five items), and (IV) oral pain and discomfort (five items). The items are answerable by a 3-point Likert scale and responses will be summed to result an overall score. Higher scores represent worse OHRQoL.
Changes from baseline to 12 months after the intervention
Satisfaction with the dentures
A 10 cm uninterrupted 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.
Changes from baseline to 12 months after the intervention
Secondary Outcomes (1)
Masticatory efficiency
Changes from baseline to 12 months after the intervention
Study Arms (2)
Mandibular complete denture
ACTIVE COMPARATORParticipants allocated to this group will not receive any additional treatment. When needed, retreatment or any adjustment/repair in the dentures will be performed accordingly. Participants will receive regular maintenance for their dentures, including adjustments for the elimination of sore areas, denture relining and repair of fractures, when needed, until the end of the follow-up period.
Single-implant mandibular overdenture
EXPERIMENTALParticipants allocated to this group will have an implant placed in the mandibular midline and after 4 weeks (healing period - early loading) an attachment system will be tightened and a retention matrix will be incorporated to the mandibular denture.
Interventions
Placement of an implant in the mandibular midline.
No intervention. Maintenance of the dentures will be done when needed.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Dentistry, Federal University of Goias
Goiânia, Goiás, 74605-220, Brazil
Related Publications (1)
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.
PMID: 27814749DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Claudio R Leles, DDS, PhD
Universidade Federal de Goias
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
March 11, 2016
First Posted
March 16, 2016
Study Start
March 1, 2016
Primary Completion
March 1, 2018
Study Completion
June 1, 2018
Last Updated
September 18, 2018
Record last verified: 2018-09