NCT01905306

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

July 23, 2013

Status Verified

July 1, 2013

Enrollment Period

3.5 years

First QC Date

July 16, 2013

Last Update Submit

July 18, 2013

Conditions

Bone-to-implant ContactSuccess RateSurvival Rate

Keywords

dental implantsimmediate loadingfull-archcomputer guided implant surgery

Outcome Measures

Primary Outcomes (1)

  • bone-to-implant contact

    2D radiographic assessment of the implant surface in contact with bone expressed in percentage

    3 years

Secondary Outcomes (1)

  • implant survival rate

    3 years

Other Outcomes (1)

  • implant success rate

    3 years

Study Arms (2)

computer guided implant planning

EXPERIMENTAL

radiographic and clinical evaluation of full-arch dental implant rehabilitation

Procedure: computer guided implant planning

free hand implants placement

EXPERIMENTAL

radiographic and clinical evaluation of full-arch dental implant rehabilitation

Procedure: free hand implants placement

Interventions

computer guided implant planningPROCEDURE
computer guided implant planning
free hand implants placementPROCEDURE
free hand implants placement

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Siena, Siena, 53100, Italy

Location

Related Publications (6)

  • Drago C, del Castillo R, Peterson T. Immediate occlusal loading in edentulous jaws, CT-guided surgery and fixed provisional prosthesis: a maxillary arch clinical report. J Prosthodont. 2011 Apr;20(3):209-17. doi: 10.1111/j.1532-849X.2010.00661.x. Epub 2010 Nov 11.

    PMID: 21070431BACKGROUND

  • Case study: computer-guided implant successful in high-risk patient. J Calif Dent Assoc. 2012 Oct;40(10):784. No abstract available.

    PMID: 23316558BACKGROUND

  • Margonar R, Queiroz TP, Luvizuto ER, Santos PL, Wady AF, Paleari AG. Anterior tooth rehabilitation with frozen homogenous bone graft and immediately loaded titanium implant using computer-guided surgery. J Craniofac Surg. 2012 Sep;23(5):e470-2. doi: 10.1097/SCS.0b013e3182587516.

    PMID: 22976712BACKGROUND

  • Nickenig HJ, Eitner S, Rothamel D, Wichmann M, Zoller JE. Possibilities and limitations of implant placement by virtual planning data and surgical guide templates. Int J Comput Dent. 2012;15(1):9-21. English, German.

    PMID: 22930944BACKGROUND

  • Shibly O, Kutkut A, Albandar JM. One-year re-entry results of guided bone regeneration around immediately placed implants with immediate or conventional loading: a case series. J Int Acad Periodontol. 2012 Jul;14(3):62-8.

    PMID: 22908535BACKGROUND

  • Schnitman PA, Lee SJ, Campard GJ, Dona M. Guided flapless surgery with immediate loading for the high narrow ridge without grafting. J Oral Implantol. 2012 Jun;38(3):279-88. doi: 10.1563/AAID-JOI-D-11-00215.

    PMID: 22783940BACKGROUND

Study Officials

  • Marco Ferrari, Prof

    University of Florence and Siena, Siena, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2013

First Posted

July 23, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2016

Last Updated

July 23, 2013

Record last verified: 2013-07

Locations

IT(1)