Randomized Controlled Trial of Full-Arch Rehabilitation

Survival Rate Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01905306
• Other study ID #: RCTGIS1
• Secondary ID: RCTGIS1s
• Status: Active, not recruiting
• Phase: N/A
• First received: July 16, 2013
• Last updated: July 18, 2013
• Start date: January 2013

Study information

• Verified date: July 2013
• Source: University of Siena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone-to-implant Contact
• Success Rate
• Survival Rate

Intervention

Procedure:
• computer guided implant planning

• free hand implants placement

Locations

Country	Name	City	State
Italy	Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Siena

Country where clinical trial is conducted

Italy, 

References & Publications (6)

Case study: computer-guided implant successful in high-risk patient. J Calif Dent Assoc. 2012 Oct;40(10):784. — View 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. Review. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	implant success rate	No pain or tenderness upon function; 0 mobility; 2 mm radiographic bone loss from initial surgery; No exudates history	3 years	No
Primary	bone-to-implant contact	2D radiographic assessment of the implant surface in contact with bone expressed in percentage	3 years	No
Secondary	implant survival rate	the absence of clinically detectable implant mobility; a lack of persistent or irreversible signs and symptoms such as pain or any subjective sensation; the absence of recurrent peri-implant infection; the absence of concrete evidence of continuous periimplant radiolucency	3 years	No