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

March 9, 2018 updated by: Cláudio Rodrigues Leles, Universidade Federal de Goias

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Goias
      • Goiânia, Goias, Brazil, 74605-220
        • School of Dentistry, Federal University of Goias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-implant mandibular overdenture
Participants allocated to this group will have a dental implant placed in the mandibular midline followed by the immediately insertion of a ball attachment and the incorporation of a retention matrix to the mandibular denture.
Procedure: Mandibular overdenture
Placement of an implant in the mandibular midline.
Other Names:
  • Dental Implant (Straumann StandardPlus SLActive® RN implant)
Active Comparator: Mandibular complete denture
Participants allocated to this group will not receive any additional treatment besides the new set of conventional complete dentures. 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.
Other: Mandibular complete denture
No intervention.
Other Names:
  • Complete denture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to 12 months after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to 12 months after the intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From denture's fabrication to 12 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Goias

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2015

Primary Completion (Actual)

September 20, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFG_020_12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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