Sleeves Versus Sleeveless Template
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|ClinicalTrials.gov Identifier: NCT03641365|
Recruitment Status : Completed
First Posted : August 22, 2018
Last Update Posted : August 27, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Guided Surgery Accuracy Dental Implant Failed Complications||Device: Test group Device: Control group||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized controlled trial of parallel group design conducted at one centre.|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||An expert blinded mechanical engineer (FC) performed all the measurements. Post-operative STL files were sent with a code, without indicating patient's group.|
|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|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||May 30, 2018|
|Actual Study Completion Date :||May 30, 2018|
Experimental: Test group
Test group: Surgical template without metallic sleeves. In this case the surgical template has all been designed and fabricated in acrylic material by mean of stereolitographic technology.
Device: Test group
Guided Implant placement Positioning/placement of dental implants thought the fully acrylic surgical template without metallic sleeves.
Other Name: Sleeveless Template
Active Comparator: Control group
Control group: Surgical template with metallic sleeves. Surgical template has designed and fabricated in acrylic material by mean of stereolitographic technology and metallic sleeves have been bonded after its production.
Device: Control group
Guided Implant placement Positioning/placement of dental implants thought the acrylic surgical template with metallic sleeves.
Other Name: Conventional Template
- Accuracy (discrepancy between virtual implant planning and placed implants) [ Time Frame: Implant placement (baseline) ]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 failure [ Time Frame: 4 months after implant placement (baseline) ]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).
- Template-related complications [ Time Frame: Implant placement ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641365
|Studio Odontoiatrico Marco Tallarico|
|Rome, Italy, 00151|
|Principal Investigator:||Marco Tallarico, Dr||Studio Marco Tallarico|