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Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment (SIOver)

Primary Purpose

Mouth, Edentulous

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Single implant-retained mandibular overdenture

About this trial

This is an interventional treatment trial for Mouth, Edentulous focused on measuring Mandibular Prosthesis Implantation, Prostheses and Implants, Denture, Complete, Lower

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

School of Dentistry, Federal University of Goias

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional implant loading protocol

Immediate loading implant protocol

Arm Description

Single implant-retained mandibular overdenture

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Satisfaction with dentures

Satisfaction with dentures measured using the patients' ratings of the overall satisfaction with the mandibular denture, and satisfaction with comfort, stability, esthetics, ability to speak, and ability to chew. All satisfaction items will be measured on a 10-point visual analogue scale ranging from 0 to 10

Full Information

NCT ID

NCT01801566

First Posted

February 25, 2013

Last Updated

March 14, 2016

Sponsor

Universidade Federal de Goias

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

1. Study Identification

Unique Protocol Identification Number

NCT01801566

Brief Title

Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment

Acronym

SIOver

Official Title

Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment: Radiographic Evaluations, Patient's Satisfaction, and Oral-health-related Quality of Life

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Goias

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study is a longitudinal evaluation of clinical and patient-reported outcomes related to the single-implant mandibular overdenture treatment. Sixty completely edentulous individuals will be included. First, new complete dentures will be fabricated for all of them. Panoramic radiographs and conventional tomograms of the mandibular midline region will be obtained in order to plan the implant placement surgery. After the adaptation period related to the use of the new dentures, a single implant (Titamax IT Cortical, Neodent, Curitiba, Brazil) will be installed in the mandibular midline of all participants. According to the primary stability obtained in the implant placement patients will be treated with an immediate loading protocol when achieving torque of at least 30 Ncm and implant stability quotient (ISQ) of at least 60. In cases of values below cited, conventional loading protocol will be adopted. Ball O-ring will be used as the attachment system for the mandibular overdenture. Clinical and patient-reported outcomes will be collected after 1, 3, 6 and 12 months after the installation of the overdentures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mouth, Edentulous

Keywords

Mandibular Prosthesis Implantation, Prostheses and Implants, Denture, Complete, Lower

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional implant loading protocol

Arm Type

Active Comparator

Arm Description

Single implant-retained mandibular overdenture

Arm Title

Immediate loading implant protocol

Arm Type

Experimental

Arm Description

Single implant-retained mandibular overdenture

Intervention Type

Procedure

Intervention Name(s)

Single implant-retained mandibular overdenture

Intervention Description

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.

Primary Outcome Measure Information:

Title

Oral health-related quality of life impacts

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Satisfaction with dentures

Description

Time Frame

Change from baseline on satisfaction with dentures at 12 months

Other Pre-specified Outcome Measures:

Title

Primary stability

Description

Measures of the implant stability: stability quotient index and final insertion torque

Time Frame

Changes from baseline on primary stability of implants at 12 months

Title

Crestal bone loss

Description

Periimplant alveolar bone height of the crestal bone level

Time Frame

Changes from baseline on crestal bone loss at 12 months

Title

Bone density around the implant

Description

Periimplant bone density measured by digital subtraction radiography

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Claudio R Leles, DDS, PhD

Organizational Affiliation

Universidade Federal de Goias

Official's Role

Principal Investigator

Facility Information:

Facility Name

School of Dentistry, Federal University of Goias

City

Goiania

State/Province

Goias

ZIP/Postal Code

74605-220

Country

Brazil

12. IPD Sharing Statement

Links:

URL

http://cnpq.br/

Description

Website of the Main study sponsor

Learn more about this trial

Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment

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