NCT03056976

Brief Summary

The aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by one and two implants and the mandibular fixed prosthesis retained by four implants, based on a randomized clinical trial.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

2.9 years

First QC Date

February 14, 2017

Last Update Submit

April 15, 2020

Conditions

Edentulous Mouth

Keywords

OverdentureDental implantComplete dentureCost analysis

Outcome Measures

Primary Outcomes (2)

  • 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".

    1-year

  • Oral health-related quality of life impacts

    Oral Health Impact Profile Instrument for edentulous subjects (OHIP-EDENT) in order to assess the impact of oral health conditions on quality of life of participants.

    1-year

Secondary Outcomes (2)

  • Masticatory efficiency

    1-year

  • Cost

    1-year

Study Arms (3)

Single-implant mandibular overdenture

EXPERIMENTAL

A single midline implant and an O'ring/ball attachment to retain a mandibular overdenture

Device: Single-implant mandibular overdenture

Two-implant mandibular overdenture

EXPERIMENTAL

Two implants in the canine region and two O'ring/ball attachments to retain a mandibular overdenture

Device: Two-implant mandibular overdenture

Fixed mandibular denture

EXPERIMENTAL

A fixed four-implant mandibular denture

Device: Fixed mandibular denture

Interventions

Single-implant mandibular overdentureDEVICE

Complete mandibular denture retained by a single midline implant

Also known as: Single-implant overdenture
Single-implant mandibular overdenture
Two-implant mandibular overdentureDEVICE

Complete mandibular denture retained by two implants in the canine region

Also known as: 2-implant overdenture
Two-implant mandibular overdenture
Fixed mandibular dentureDEVICE

A fixed mandibular denture retained by four implants

Also known as: Full-arch mandibular prothesis
Fixed mandibular denture

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • No contraindications for implant surgery (mainly related to uncontrolled systemic diseases)
  • Present enough bone volume in the mandible 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

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: 27814749BACKGROUND

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Enilza Paiva, PhD

    Dean of the Dental School, Federal University of Goias

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparative effectiveness of thre competing strategies for the edentulous mandible using implants
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 14, 2017

First Posted

February 17, 2017

Study Start

July 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

April 16, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share