Randomized Controlled Trial of Full-Arch Rehabilitation

NCT ID: NCT01905306

Last Updated: 2013-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bone-to-implant Contact Success Rate Survival Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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computer guided implant planning

radiographic and clinical evaluation of full-arch dental implant rehabilitation

Group Type EXPERIMENTAL

computer guided implant planning

Intervention Type PROCEDURE

free hand implants placement

radiographic and clinical evaluation of full-arch dental implant rehabilitation

Group Type EXPERIMENTAL

free hand implants placement

Intervention Type PROCEDURE

Interventions

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computer guided implant planning

Intervention Type PROCEDURE

free hand implants placement

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Siena

OTHER

Sponsor Role lead

Responsible Party

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Prof. Marco Ferrari

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco Ferrari, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Florence and Siena, Siena, Italy

Locations

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

Siena, Siena, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 21070431 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 23316558 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22976712 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22930944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22908535 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22783940 (View on PubMed)

Other Identifiers

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RCTGIS1s

Identifier Type: OTHER

Identifier Source: secondary_id

RCTGIS1

Identifier Type: -

Identifier Source: org_study_id

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