Clinical trial NCT01801566: Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment
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
Overall status: COMPLETED
Phase: NA
Conditions: Mouth, Edentulous
Keywords: Mandibular Prosthesis Implantation
Prostheses and Implants
Denture, Complete, Lower
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2013-03-01
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Oral health-related quality of life impacts
timeFrame: Change from baseline on oral health-related quality of life impacts at 12 months
Secondary outcomes:
measure: Satisfaction with dentures
timeFrame: Change from baseline on satisfaction with dentures at 12 months
Other outcomes:
measure: Primary stability
timeFrame: Changes from baseline on primary stability of implants at 12 months
measure: Crestal bone loss
timeFrame: Changes from baseline on crestal bone loss at 12 months
measure: Bone density around the implant
timeFrame: Changes from baseline on bone density around the implant at 12 months
Locations:
city: Goiania
country: Brazil
facility: School of Dentistry, Federal University of Goias
state: Goias
Study officials:
affiliation: Universidade Federal de Goias
name: Claudio R Leles, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References: