NCT01801566

Brief Summary

This study aims to evaluate the treatment with single implant overdenture for the edentulous mandible. The investigators hypothesize that treatment with lower overdenture retained by a single implant appears to have satisfactory effectiveness as a treatment for patients with specific conditions (such as maladaptive patients), with the advantages of simplicity and greater immediate benefits when compared to the conventional full denture, improving the retention and stability of the denture and better oral-related quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

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

First Submitted

Initial submission to the registry

February 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

1.5 years

First QC Date

February 25, 2013

Last Update Submit

March 14, 2016

Conditions

Mouth, Edentulous

Keywords

Mandibular Prosthesis ImplantationProstheses and ImplantsDenture, Complete, Lower

Outcome Measures

Primary Outcomes (1)

  • Oral health-related quality of life impacts

    Oral health related quality of life impacts were measured using the Brazilian version of the Oral Health Impact Profile for Edentulous subjects (Souza et al., 2007; Souza et al., 2010), considering the overall scale and its four different scale domains: masticatory discomfort and disability (four items), (2) psychological discomfort and disability (five items), social disability (five items) and oral pain and discomfort (five items).

    Change from baseline on oral health-related quality of life impacts at 12 months

Secondary Outcomes (1)

  • Satisfaction with dentures

    Change from baseline on satisfaction with dentures at 12 months

Other Outcomes (3)

  • Primary stability

    Changes from baseline on primary stability of implants at 12 months

  • Crestal bone loss

    Changes from baseline on crestal bone loss at 12 months

  • Bone density around the implant

    Changes from baseline on bone density around the implant at 12 months

Study Arms (2)

Conventional implant loading protocol

ACTIVE COMPARATOR

Single implant-retained mandibular overdenture

Procedure: Single implant-retained mandibular overdenture

Immediate loading implant protocol

EXPERIMENTAL

Single implant-retained mandibular overdenture

Procedure: Single implant-retained mandibular overdenture

Interventions

Single implant-retained mandibular overdenturePROCEDURE

60 patients treated with single implant retained complete mandibular denture (overdenture) opposed to a conventional maxillary denture, allocated into 2 experimental groups according to the implant loading protocol (conventional and immediate), evaluated at baseline and after 1, 3, 6 and 12 months after treatment.

Conventional implant loading protocolImmediate loading implant protocol

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fully edentulous patients
  • Need of replacement of the mandibular denture or patient without mandibular denture
  • Patients with poor adaptation to the mandibular denture
  • Patients with good general health

You may not qualify if:

  • Patients who refuse to receive a conventional dentures opposed to a mandibular overdenture retained by a single implant
  • Patients with local intraoral diseases that influence denture stability, retention and adaptation of the lower denture (such as changes or anatomical deformations of the jaws, mucosal changes caused by fungi and bacteria, tumor changes and absolute xerostomia)
  • Patients with systemic, psychological or neurological diseases that preclude or hinder oral movements of the patient for clinical care and/or clinical follow-up in all stages of the research
  • Patients who choose other treatment modalities not covered by the study
  • Patients with alcoholism or other severe behavioral disorders that compromise their participation in the study

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

Related Links

MeSH Terms

Conditions

Mouth, Edentulous

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesTooth Diseases

Study Officials

  • Claudio R Leles, DDS, PhD

    Universidade Federal de Goias

    PRINCIPAL INVESTIGATOR

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

February 25, 2013

First Posted

March 1, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

BR(1)