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
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.
This study was designed as a randomized controlled trial of parallel group design conducted
at one centre, between May 2016 and March 2017. The study was performed after approval was
received from the institutional review board of the Aldent University, Tirana, Albania
(2/2017).
The investigation was conducted according to the principles embodied in the Helsinki
Declaration of 1975 for biomedical research involving human subjects, as revised in 2013. All
patients were informed about the nature of the treatment and their written consent was
obtained. Data collection was designed to preserve patient anonymity.
- Inclusion/exclusion criteria:
Any partially edentulous patient, aged 18 years or older, able to sign an informed consent,
in need of an implant-supported fixed restoration was considered eligible for this study. Any
potential implant location based on individual patient requirements was considered eligible
in the present trial. Patients were not admitted to the study if any of the following
exclusion criteria was present: general medical contraindication to oral surgery (American
Society of Anesthesiologist, ASA, class III or IV); irradiation in the head and neck area
less than one year before implantation; psychiatric problems; alcohol or drug abuse; pregnant
or nursing; untreated periodontitis; severe bruxism or clenching; uncontrolled diabetes; poor
oral hygiene and motivation; and inability to complete the follow-up.
Enrolled patients received preoperative photographs, periapical radiographs or panoramic
x-rays for initial screening and evaluation. The prosthetic-driven planning workflow started
by taking a cone beam computed tomography (CBCT) scan (Cranex 3Dx, Soredex, Tuusula, Finland)
by using a wax bite to separate dental arches. Then, the patients received intraoral digital
impression taken using the 3M True Definition Scanner (3M Italia, Pioltello, Milano). The
digital data (STL, STereo Lithography interface format) was imported in a 3D design software
(exocad DentalCAD, Exocad GmbH, Darmstadt, Germany) to realize a virtual wax-up according to
the functional and esthetic requirements. Then, the STL and DICOM (Digital Imaging and
COmmunications in Medicine) data were imported in a 3D software planning program (3Diagnosys
ver. 5.0, 3DIEMME srl, Cantù, Italy). Then, the reprocessed surface extrapolated from the
DICOM data (by using a Hounsfield scale filter) and the surface generated by the master cast
scanning process, or by the intraoral scanning process, were merged with the best-fitting
repositioning tools of the software (3Diagnosys ver. 5.0, 3DIEMME srl). At this point,
prosthetic-driven implants/abutments size and location were planned taking into account the
bone quality and quantity, soft tissue thickness, anatomical landmarks, as well as, type,
volume and shape of the final restoration. After careful functional and esthetic evaluation
and final verification, the prosthetic-driven plan was approved. At this point, patients were
randomly assigned to receive conventional stereolithographic surgical template with (control
group) or without (test group) metallic sleeves. Stereolithographic surgical templates were
designed and fabricated by an independent certified center not previously involved in the
study (New Ancorvis srl, Bargellino, Italy). In the test group, conventional templates with
close-sleeve-design were produced to place implants between premolars. In case of implants to
be place in molar area, template with open sites were produced to solve intermaxillary space
limits.
- Surgical protocol:
One hour before implant placement, all patients underwent professional oral hygiene,
prophylactic antiseptic with 0.2% chlorhexidine (Curasept, Curaden Healthcare, Saronno,
Italy) for one minute, and prophylactic antibiotic therapy (2 g of amoxicillin or clindamycin
600 mg if allergic to penicillin). The fit of the surgical templates were accurately tried in
the patient mouth to achieve a stable fit (Fit Checker, GC - Tokyo, Japan). All patients were
treated under local anesthesia using articaine with adrenaline 1:100000 administered 20
minute before surgery. The surgical templates were stabilized on the residual teeth and fixed
with two to three preplanned anchor pins.Hopeless teeth were extracted at the end of the
intervention in order to improve the stability of the surgical template and to provide more
reference point for measurements of the implant accuracy. Nevertheless, in case of immediate
postextractive implants, residual teeth were extracted as atraumatically as possible
immediately before surgery. In the test group, planned implants (Osstem TSIII, Osstem, Seoul,
South Korea) were placed flapless using dedicate drills (OneGuide Kit, Osstem) in combination
with a sleeveless surgical guide. In this case the drills were used directly thought the
sleeve-designed template without metallic tubs and with not the need of drill reductions. In
the control group, planned implants (Osstem TSIII, Osstem, Seoul, South Korea) were placed
flapless using dedicate drills (OsstemGuide Kit[Taper], Osstem) in combination with reduction
tools, within the surgical templates containing metallic sleeves. If the keratinized gingiva
and the amount of bone were adequate, the implants were placed flapless. Otherwise, a flap
was elevated and then the wound was closed with single-stitch sutures using 4.0 resorbable
suture material (Vicryl, Ethicon J&J International, Sint-Stevens-Woluwe, Belgium). Implant
site were prepared based on the bone density evaluated by the surgeon at the first drill. All
the implant were inserted according to a one-stage protocol, with an insertion torque ranging
from 35 to 45 Ncm. In case of poor bone density, the implant site was underprepared.
Immediately after implant placement, patients of both groups receive a digital impression (3M
True Definition Scanner, 3M Italia, Pioltello, Milano) taken at implant level using a
dedicate abutments (Scan body type AQ, New Ancorvis srl), to check the position of the placed
implants.
Following implant placement, all patients received oral and written recommendations about
medication, oral hygiene maintenance and diet. Implants were loaded after 8 to 12 weeks of
healing. Then, patients were followed twice a year for hygiene maintenance and occlusal
control.
- Outcome measurements:
- 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).
- 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. All the complications were recorded during follow-up by the same
clinician (Marco Tallarico), who performed all the surgical procedures.
- Accuracy: 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.
- Randomization:
One computer-generated restricted randomization list was created. Only one of the
investigators, not involved in the selection and treatment of the patients, was aware of the
random sequence and could have access to the randomization lists stored in a
password-protected portable computer. The random codes were enclosed in sequentially
numbered, identical, opaque, sealed envelopes. Envelopes were opened sequentially after the
prosthetic-driven plan was approved.
- Statistical analysis:
Patient data were collected in a Numbers spreadsheet (Version 3.6.1 for Mac OS X 10.11.4). A
bio-statistician with expertise in dentistry analyzed the data using SPSS software for Mac OS
X (version 22.0; SPSS Inc., Chicago, IL, USA) for statistical analysis. Descriptive analysis
was performed for numeric parameters using mean±standard deviation and median with confidence
interval (95% CI). Implant failure and template-related complications between the two groups
were compared using Fisher's exact probability test. The mean differences of the overall
deviation in the clinical outcomes compared to the virtual plan, were compared between groups
using a mixed-model repeated-measures analysis of variance (ANOVA). In the sleeve-less group,
accuracy of open versus closed holes were also evaluated. All statistical comparisons were
conducted with a P value set at 0.05.
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