Clinical trial NCT01905306: Randomized Controlled Trial of Full-Arch Rehabilitation
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone-to-implant Contact
Success Rate
Survival Rate
Keywords: dental implants
immediate loading
full-arch
computer guided implant surgery
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: bone-to-implant contact
timeFrame: 3 years
Secondary outcomes:
measure: implant survival rate
timeFrame: 3 years
Other outcomes:
measure: implant success rate
timeFrame: 3 years
Locations:
city: Siena
country: Italy
facility: Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena
Study officials:
affiliation: University of Florence and Siena, Siena, Italy
name: Marco Ferrari, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Case study: computer-guided implant successful in high-risk patient. J Calif Dent Assoc. 2012 Oct;40(10):784. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.