Randomized Controlled Trial of Full-Arch Rehabilitation

Not Applicable

• Conditions: Bone-to-implant Contact; Success Rate; Survival Rate
• Interventions: Procedure: free hand implants placement; Procedure: computer guided implant planning

• Registration Number: NCT01905306
• Lead Sponsor: University of Siena

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Status Verified: 2013-07
• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-18
• Last Update Submitted: 2013-07-18
• Study First Posted: 2013-07-23
• Last Update Posted: 2013-07-23
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
free hand implants placement	free hand implants placement	radiographic and clinical evaluation of full-arch dental implant rehabilitation
computer guided implant planning	computer guided implant planning	radiographic and clinical evaluation of full-arch dental implant rehabilitation

Primary Outcome Measures

Name	Time	Method
bone-to-implant contact	3 years	2D radiographic assessment of the implant surface in contact with bone expressed in percentage

Secondary Outcome Measures

Name	Time	Method
implant survival rate	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

Trial Locations

Locations (1)

Department of Dental Materials and Fixed Prosthodontics of Siena, Tuscan School of Dental Medicine, University of Florence and Siena; 🇮🇹 Siena, Italy