Sleeves Versus Sleeveless Template

NCT03641365 | Completed

• 1 other identifier: Osstem_001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Guided Surgery Accuracy; Dental Implant Failed; Complications

Keywords

Intraoral scanner; Guided surgery; Implant accuracy; Dental implants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Implant failure

  4 months after implant placement (baseline)

• Template-related complications

  Implant placement

Study Arms (2)

Test group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

Test group DEVICE

Guided Implant placement Positioning/placement of dental implants thought the fully acrylic surgical template without metallic sleeves.

Also known as: Sleeveless Template

Test group

Control group DEVICE

Guided Implant placement Positioning/placement of dental implants thought the acrylic surgical template with metallic sleeves.

Also known as: Conventional Template

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Partially edentulous patient
• Aged 18 years or older
• Able to sign an informed consent
• In need of an implant-supported fixed restoration

You may not qualify if:

• 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.

Sponsors & Collaborators

• Osstem AIC: lead

Study Sites (1)

Studio Odontoiatrico Marco Tallarico

Rome, 00151, Italy

Location

Related Publications (3)

• 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.

  PMID: 19906267 BACKGROUND

• 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.

  PMID: 28000275 BACKGROUND

• 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.

  PMID: 29806667 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Marco Tallarico, Dr

  Studio Marco Tallarico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: An expert blinded mechanical engineer (FC) performed all the measurements. Post-operative STL files were sent with a code, without indicating patient's group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial of parallel group design conducted at one centre.

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 22, 2018
• Study Start: September 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

IT (1)