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Completed

NCT Number: NCT01801566

Effectiveness of the Single Implant-retained Mandibular Overdenture Treatment

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.

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Key information

Conditions

Mouth, Edentulous Mouth Diseases Stomatognathic Diseases Tooth Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry, Federal University of Goias

Goiânia, Goiás, 74605-220, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single implant-retained mandibular overdenture

Procedure

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 outcomes

  1. 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).

Secondary outcomes

  1. 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

Other outcomes

  1. Primary stability

    Time frame: Changes from baseline on primary stability of implants at 12 months

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

  2. Crestal bone loss

    Time frame: Changes from baseline on crestal bone loss at 12 months

    Periimplant alveolar bone height of the crestal bone level

  3. Bone density around the implant

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

    Periimplant bone density measured by digital subtraction radiography

Sponsors and collaborators

Lead sponsor

Universidade Federal de Goias

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Acronym: SIOver

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 1, 2013
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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