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Completed

NCT Number: NCT03463174

Cost-effectiveness of the Single-implant Mandibular Overdenture Versus Mandibular Conventional Denture

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.

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Key information

Conditions

Mouth, Edentulous Complete Edentulism Mouth Diseases Stomatognathic Diseases Tooth Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, Federal University of Goias

Goiânia, Goiás, 74605-220, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mandibular overdenture

Procedure

Placement of an implant in the mandibular midline.

Other names: Dental Implant (Straumann StandardPlus SLActive® RN implant)

Mandibular complete denture

Other

No intervention.

Other names: Complete denture

Primary outcomes

  1. Oral health-related quality of life (OHRQoL)

    Time frame: From baseline to 12 months after the intervention

    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.

Secondary outcomes

  1. Satisfaction with the dentures

    Time frame: From baseline to 12 months after the intervention

    Participants will report how satisfied they are on a 0-100 scale by choosing a multiple of 10. Zero will be considered the least satisfied possible and "100" the most satisfied possible.

Other outcomes

  1. Costs

    Time frame: From denture's fabrication to 12 months after the intervention

    All the direct dental costs related to the clinical and laboratory phases of both treatment groups will be listed, measured and valued.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Goias

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

A Randomized Controlled Clinical Trial Alongside a Cost-effectiveness Analysis of the Mandibular Conventional Complete Denture Versus Single-implant Mandibular Overdenture

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 13, 2018
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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