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Randomized Controlled Trial of Full-Arch Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01905306
Recruitment Status : Unknown
Verified July 2013 by Prof. Marco Ferrari, University of Siena.
Recruitment status was:  Active, not recruiting
First Posted : July 23, 2013
Last Update Posted : July 23, 2013
Sponsor:
Information provided by (Responsible Party):
Prof. Marco Ferrari, University of Siena

Brief Summary:
This clinical study has the objective to compare the radiographic evaluations after 3 years of follow-up of immediate loaded implant-prosthetic rehabilitation, carried out randomly using the methodology for computer guided implant planning with software polyvalent or free hand implants placement.

Condition or disease Intervention/treatment Phase
Bone-to-implant Contact Success Rate Survival Rate Procedure: computer guided implant planning Procedure: free hand implants placement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Immediate Loading Full Arch Rehabilitation Made With Methodology for Computer Guided Implant Planning With Software Polyvalent vs Free Hand Implants Placement
Study Start Date : January 2013
Estimated Primary Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: computer guided implant planning
radiographic and clinical evaluation of full-arch dental implant rehabilitation
Procedure: computer guided implant planning
Experimental: free hand implants placement
radiographic and clinical evaluation of full-arch dental implant rehabilitation
Procedure: free hand implants placement



Primary Outcome Measures :
  1. bone-to-implant contact [ Time Frame: 3 years ]
    2D radiographic assessment of the implant surface in contact with bone expressed in percentage


Secondary Outcome Measures :
  1. implant survival rate [ Time Frame: 3 years ]
    1. the absence of clinically detectable implant mobility
    2. a lack of persistent or irreversible signs and symptoms such as pain or any subjective sensation
    3. the absence of recurrent peri-implant infection
    4. the absence of concrete evidence of continuous periimplant radiolucency


Other Outcome Measures:
  1. implant success rate [ Time Frame: 3 years ]
    1. No pain or tenderness upon function
    2. 0 mobility
    3. 2 mm radiographic bone loss from initial surgery
    4. No exudates history



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Edentulous patients with an adequate area: at least two teeth in the posterior area
  • Age over 18 years
  • Adequate width of the bone crest without the need for bone regeneration
  • Consensus to participate in a oral hygiene maintenance program
  • Consensus to participate in a long-term study
  • Availability to provide their free and informed consensus.

Exclusion Criteria:

  • Systemic diseases that preclude participation in the study
  • History of radiation therapy
  • Bone lesions
  • Cigarette smoking (more than 10 cigarettes per day)
  • Inadequate oral hygiene
  • Untreated periodontitis affecting residual teeth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905306


Locations
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Italy
Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena
Siena, Italy, 53100
Sponsors and Collaborators
University of Siena
Investigators
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Principal Investigator: Marco Ferrari, Prof University of Florence and Siena, Siena, Italy
Publications:
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Responsible Party: Prof. Marco Ferrari, Professor, University of Siena
ClinicalTrials.gov Identifier: NCT01905306    
Other Study ID Numbers: RCTGIS1
RCTGIS1s ( Other Identifier: University of Siena )
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 2013
Keywords provided by Prof. Marco Ferrari, University of Siena:
dental implants
immediate loading
full-arch
computer guided implant surgery