NCT03691285

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 9, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

2.3 years

First QC Date

September 28, 2018

Last Update Submit

April 15, 2020

Conditions

Edentulous Mouth

Keywords

OverdentureDental implantCost analysis

Outcome Measures

Primary Outcomes (1)

  • Satisfaction with the dentures

    A 100 cm graduated 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 (3)

  • Masticatory efficiency

    Changes from baseline to 12 months after the intervention

  • Pain and discomfort

    24 hours, 7 days and 21 days after surgery

  • Oral health-related quality of life impacts

    Changes from baseline to 12 months after the intervention

Study Arms (2)

Single-implant mandibular overdenture

EXPERIMENTAL

Participants allocated to this group will have an implant placed in the mandibular midline and after 3 weeks (healing period - early loading) an attachment system will be tightened and a retention matrix will be incorporated to the mandibular denture.

Procedure: Mandibular Overdenture

Two-implant mandibular overdenture

ACTIVE COMPARATOR

Participants allocated to this group will have two implants placed in the inter-foraminal region after 3 weeks (healing period - early loading) an attachment system will be tightened and a retention matrix will be incorporated to the mandibular denture.

Procedure: Mandibular Overdenture

Interventions

Mandibular OverdenturePROCEDURE

Placement of 1 or 2 implants in the anterior region of the edentulous mandible.

Single-implant mandibular overdentureTwo-implant mandibular overdenture

Eligibility Criteria

Sexall
Healthy VolunteersYes
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 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

Location

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
To avoid selection bias and ensure adequate allocation concealment, their treatment group will only be revealed for each participant after the assessment of the baseline outcomes, which will occur after the delivery and regular use of the new set of conventional dentures. Since full blinding for the two interventions is not possible for those involved with treatment management and collection of data, only those collecting and analyzing clinical data from masticatory performance tests will be unaware of the assigned treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Comparative effectiveness of two competing strategies for the edentulous mandible using implants
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 28, 2018

First Posted

October 1, 2018

Study Start

April 9, 2017

Primary Completion

July 30, 2019

Study Completion

July 30, 2019

Last Updated

April 16, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)