Randomized Controlled Trial of Full-Arch Rehabilitation

July 18, 2013 updated by: Prof. Marco Ferrari, University of Siena

Clinical Evaluation of Immediate Loading Full Arch Rehabilitation Made With Methodology for Computer Guided Implant Planning With Software Polyvalent vs Free Hand Implants Placement

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Siena, Italy, 53100
        • Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone-to-implant contact
Time Frame: 3 years
2D radiographic assessment of the implant surface in contact with bone expressed in percentage
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Investigators

  • Principal Investigator: Marco Ferrari, Prof, University of Florence and Siena, Siena, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (Estimate)

July 23, 2013

Study Record Updates

Last Update Posted (Estimate)

July 23, 2013

Last Update Submitted That Met QC Criteria

July 18, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RCTGIS1
  • RCTGIS1s (Other Identifier: University of Siena)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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