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rev port estomatol med dent cir maxilofac . 2021;62(1):9-15             11


           ferent results, concluding that implant length has no signifi-  techniques (panoramic and intraoral radiographs, dental com-
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           cant effect on implant stability.  However, those authors con-  puterized tomographs) were applied for all patients for proper
           cluded that ISQ values increased with increased implant   pre -surgical planning.
           diameter, and tapered implants showed higher ISQ values   Immediately before surgery, the mouth was rinsed with a
           than parallel implants. Given the diversity of the current re-  0.12% chlorhexidine solution (Eludril, Laboratoires Pierre Fab-
           sults, it is important to carry out a clinical trial that simulta-  re, France) for 1 minute. The surgical procedures were done
           neously studies the different factors that appear to influence   under local anesthesia (articaine containing 1:100000 epineph-
           implant stability.                                  rine – Artinibsa, Inibsa), using loco -regional or infiltrative an-
              Therefore, this randomized controlled clinical trial aims to   esthesia techniques, according to the anatomical region. A
           evaluate the influence of implant length, diameter, design, and   midcrestal incision was made, and a full -thickness flap was
           anatomic region on ISQ values during osseointegration. The   obtained.
           research hypothesis was that ISQ values are affected by jaw   The implants were placed according to the manufacturer’s
           region, implant diameter, implant length, and implant design.  instructions.  A one -stage surgical protocol with non-
                                                               -immediate loading was planned for this study. For definition
                                                               purposes, implants placed in the “anterior” region were meant
           Material and Methods                                to replace central and lateral incisors and canines, whereas
                                                               those in the “posterior” region were placed to replace premo-
           A prospective, randomized, parallel -group, controlled clinical   lars and molars. Implants were surgically positioned with the
           trial was carried out at the Implant Dentistry Postgraduate   implant shoulder at the level of the alveolar bone crest. Prima-
           Program of the Faculty of Dental Medicine of the University of   ry closure of the wound was made using 3 -0 polyglactin 910
           Lisbon (FMDUL), Lisbon, Portugal. Inclusion criteria were   single sutures (Vicryl Rapide, Ethicon). Post -operative antibi-
           adults with good general health, non -smokers, with at least   otic (amoxicillin, 1 g, 12/12 hours for 8 days) and analgesic
           one tooth missing for more than 6 months and sufficient   (paracetamol, 1 g, 8/8 hours for 2 days) were prescribed. All
           bone height/width for implant placement without the need   patients were instructed to follow a soft cold diet for the first
           for bone augmentation. Exclusion criteria included patients   24 hours and mouthwash with chlorhexidine 0.2% for a week.
           with uncontrolled systemic diseases, history of head/neck ir-  RFA was employed to measure implant stability. RFA mea-
           radiation, immune system severe deficiencies, smokers, and   surements were taken immediately after implant placement
           patients treated with oral/intravenous bisphosphonates.  (T0) and 8 weeks later (T1), using the Osstell Mentor device
              Using G*Power (version 3.1.9.4, Heinrich -Heine -University,   (Ostell Integration Diagnostics, Goteborg, Sweden). For each
           Germany), a minimum sample size of 70 implants was calcu-  implant, ISQ values were measured from the three orienta-
           lated as required to detect comparisons between the two   tions (buccal, lingual, and occlusal), according to the method
           groups, considering a statistical power of 80% and estimated   described by Rokn.  The mean of all measurements was re-
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           dropouts. The eligible patients were randomly allocated into   garded as the final ISQ of the implant. A single operator made
           two different groups by simple randomization (using GraphPad   all measurements and recordings.
           Software, QuickCalcs – website http://www.graphpad.com) ac-  Data were analyzed using IBM SPSS Statistics version 25.0
           cording to implant design: Group A – C1 implants (MIS Im-  (IBM Corp., Armonk, NY, USA). The t -test or Mann -Whitney U
           plants Technologies Ltd) and Group B – Seven implants (MIS   test and ANOVA or Kruskal -Wallis tests were used according
           Implants Technologies Ltd).                         to groups of variables, normality of the distribution, and ho-
              The study was approved by the Ethics Committee of the   mogeneity of variance. The t -test was used for groups of two
           FMDUL, Lisbon, Portugal. All procedures followed the stan-  qualitative variables with normal distribution, and the Mann-
           dards of the Helsinki Declaration of 1975, as revised in 2000.   -Whitney U test was applied if they had a non -normal distri-
           All patients were fully informed of the nature of the study and   bution. ANOVA was used for groups of three or more variables
           signed an informed consent form.                    if the distribution was normal and variance was homoge-
              A total of 79 implants were placed: 40 MIS C1 implants and   neous; if not, Kruskal -Wallis was applied. The level of signifi-
           39 MIS Seven implants (MIS Implants Technologies Ltd). All   cance was set at p <0.05. Multiple comparisons were made to
           implants had the same surface: sandblasted and acid -etched   identify significant differences between groups. The quantita-
           surface. C1 implants feature a 12 -degree conical connection   tive variables analyzed were mean primary stability and mean
           that ensures a secure fit between abutment and implant. The   secondary stability.
           C1 implant has a dual thread design (range 1.5 mm) over the
           entire implant body. The apical region of C1 implant features
           two cutting blades establishing the self -tapping properties.   Results
           Seven implants’ apical region features an internal hexagon
           connection and a dual thread design (range 2 mm), sharper at   A total of 45 patients (28 women and 17 men) with an average
           the apex and gradually lessening toward the neck. Both im-  age of 46 years were included and received 79 implants. No
           plants have conical root -shaped geometry and micro -rings at   dropouts were registered. The number of implants inserted
           the neck.                                           was 47 (59.5%) in women and 32 (40.5%) in men. The implants’
              All surgeries were performed by postgraduate students of   length was 8.0 mm, 10.0 mm, 11.0 mm, and 11.5 mm, and
           the Implantology Postgraduate Program, FMDUL, Lisbon, Por-  their diameter was 3.75 mm and 4.20 mm. Of the 79 implants
           tugal, under the supervision of surgery instructors. Imaging   studied, 3 MIS Seven implants were excluded due to osseoin-
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