Clinical Trial: Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Universidade Federal de Goias

Current Primary Outcome: Oral health-related quality of life impacts [ Time Frame: Change from baseline on oral health-related quality of life impacts at 12 months ]

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).


Original Primary Outcome: Same as current

Current Secondary Outcome: Satisfaction with dentures [ Time Frame: Change from baseline on satisfaction with dentures at 12 months ]

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


Original Secondary Outcome: Same as current

Information By: Universidade Federal de Goias

Dates:
Date Received: February 25, 2013
Date Started: April 2013
Date Completion:
Last Updated: March 14, 2016
Last Verified: March 2016