Complications Clinical Trial
Official title:
Accuracy of Computer-assisted Template-based Implant Placement Using CAD/CAM Stereolithographic Surgical Templates With or Without Metallic Sleeves: a Randomized Controlled Trial
Verified date | August 2018 |
Source | Osstem AIC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare virtual planning accuracy of computer-assisted template-based implant placement
using CAD/CAM stereolithographic surgical templates with or without metallic
sleeves.Furthermore to compare open versus closed holes in case of sleeveless templates.
Any partially edentulous patients requiring at least one implant to be planed according to a
computer-assisted template-based protocol were enrolled. Patients were randomised according
to a parallel group design into two arms: surgical template with or without metallic sleeves.
Three deviation parameters (angular, horizontal, vertical) were defined to evaluate the
discrepancy between the planned and placed implant positions.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 30, 2018 |
Est. primary completion date | May 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Partially edentulous patient - Aged 18 years or older - Able to sign an informed consent - In need of an implant-supported fixed restoration Exclusion Criteria: - General medical contraindication to oral surgery (American Society of Anesthesiologist, ASA, class III or IV) including uncontrolled diabetes - Irradiation in the head and neck area less than one year before implantation - Psychiatric problems - Alcohol or drug abuse - Pregnant or nursing - Untreated periodontitis or poor oral hygiene and motivation - Severe bruxism or clenching - Inability to complete the follow-up. |
Country | Name | City | State |
---|---|---|---|
Italy | Studio Odontoiatrico Marco Tallarico | Rome |
Lead Sponsor | Collaborator |
---|---|
Osstem AIC |
Italy,
D'haese J, Ackhurst J, Wismeijer D, De Bruyn H, Tahmaseb A. Current state of the art of computer-guided implant surgery. Periodontol 2000. 2017 Feb;73(1):121-133. doi: 10.1111/prd.12175. Review. — View Citation
D'haese J, Van De Velde T, Elaut L, De Bruyn H. A prospective study on the accuracy of mucosally supported stereolithographic surgical guides in fully edentulous maxillae. Clin Implant Dent Relat Res. 2012 Apr;14(2):293-303. doi: 10.1111/j.1708-8208.2009.00255.x. Epub 2009 Nov 10. — View Citation
Tallarico M, Esposito M, Xhanari E, Caneva M, Meloni SM. Computer-guided vs freehand placement of immediately loaded dental implants: 5-year postloading results of a randomised controlled trial. Eur J Oral Implantol. 2018;11(2):203-213. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy (discrepancy between virtual implant planning and placed implants) | Three deviation parameters (horizontal, vertical, and angular) were defined and calculated between the planned and placed implant positions. The post-operative STL file, derived from the intraoral scan, was geometrically aligned with the files exported from the planning, by automated image registration using maximization of mutual information (Dental SCAN, ver.6, Open Technologies srl, Brescia, Italy). The horizontal (lateral), vertical (depth) and angular deviation between virtual and placed implants were calculated along the long axis of each implants. An expert blinded mechanical engineer (FC) performed all the measurements. | Implant placement (baseline) | |
Secondary | Implant failure | An implant was considered to be a failure if it was lost for mobility, implant fracture and/or any infection dictating implant removal. The stability of each individual implant was measured manually with a torque of 20 Ncm at delivery of the final restoration and later, with the prosthesis removed, if needed (infection, extensive peri-apical bone loss, mucosal inflammation). | 4 months after implant placement (baseline) | |
Secondary | Template-related complications | Early surgical complications involved the surgical template comprised limited access in posterior areas, buccal bony dehiscence (due to a mismatching of the surgical template) evaluated sounding the implant site with a periodontal probe (PCPUNC156, Hu-Friedy Italy, Milan, Italy) before implant placement, insertion of different implant than planned, and fracture of surgical template. | Implant placement |
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