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

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

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.

Study Overview

• Status: Completed
• Conditions: Mouth, Edentulous
• Intervention / Treatment: Procedure: Single implant-retained mandibular overdenture

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional implant loading protocol; Single implant-retained mandibular overdenture	Procedure: Single implant-retained mandibular overdenture; 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.
EXPERIMENTAL: Immediate loading implant protocol; Single implant-retained mandibular overdenture	Procedure: Single implant-retained mandibular overdenture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from baseline on satisfaction with dentures at 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary stability	Measures of the implant stability: stability quotient index and final insertion torque	Changes from baseline on primary stability of implants at 12 months
Crestal bone loss	Periimplant alveolar bone height of the crestal bone level	Changes from baseline on crestal bone loss at 12 months
Bone density around the implant	Periimplant bone density measured by digital subtraction radiography	Changes from baseline on bone density around the implant at 12 months

Collaborators and Investigators

• Sponsor: Universidade Federal de Goias
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Claudio R Leles, DDS, PhD, Universidade Federal de Goias

Publications and helpful links

Helpful Links

• Website of the Main study sponsor

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: February 25, 2013
• First Submitted That Met QC Criteria: February 28, 2013
• First Posted (ESTIMATE): March 1, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 16, 2016
• Last Update Submitted That Met QC Criteria: March 14, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: Prostheses and Implants; Mandibular Prosthesis Implantation; Denture, Complete, Lower
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: U1111-1129-9956