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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
Sponsor:
Information provided by (Responsible Party):
Marco Tallarico, Osstem AIC

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
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.
Primary Purpose: Other
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Italy
Studio Odontoiatrico Marco Tallarico
Rome, Italy, 00151
Sponsors and Collaborators
Osstem AIC
Investigators
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Principal Investigator: Marco Tallarico, Dr Studio Marco Tallarico
  Study Documents (Full-Text)

Documents provided by Marco Tallarico, Osstem AIC:
Statistical Analysis Plan  [PDF] July 30, 2018