Methods : Comparative evaluation of the stability of two different dental implant designs and surgical protocols—a pilot study
Methods
Following proper approval by the LSUHSC Institution Review Board (LSUNO IRB#7438), 27 (30 implant sites) systemically healthy patients at least 18 years old were enrolled in the study and randomly divided into three groups as follows (inclusion and exclusion criteria are described in detail in Table 1):
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Group A received 10 OSPTX implants using the soft bone surgical protocol (OSPTXSoft).
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Group B received 10 OSPTX implants using the standard surgical protocol (OSPTXStd).
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Group C received 10 OSP implants using the standard surgical protocol (OSPStd).
To facilitate randomization, the manufacturer packaged each implant with a prescribed surgical protocol included. The surgeon was blinded to the implant type until the opening of the package when the patient was seated for the surgery.
The soft bone drilling protocol used for group A results in an underpreparation compared to the implant diameter by −0.5 mm at the body portion. Corresponding underpreparation at the apex is from the beginning of apex towards the tip of the implant −0.8, −0.4, and 0 mm, respectively. All implants were of 4 mm diameter and 8 mm length and were placed at sites coronal to the maxillary sinus where at least 8-mm bone height was available. Every patient received a cone beam computed tomography (CBCT) evaluation pre-operatively using an i-CAT® unit. Bone quality was measured clinically by the surgeon during preparation of the osteotomy. Implants were placed following a two-stage protocol. They were uncovered at 6 weeks at which time functionally loaded screw-retained provisional crown was delivered per a FDA approved protocol for this implant system. Implant stability was measured by insertion torque using a calibrated torque wrench at the time of implant placement and by ISQ measurements using the Osstell™ unit at the time of implant placement and at 6 weeks and 6 and 12 months (Fig. 2). Standardized periapical radiographs were taken at the time of implant placement and at 6 and 12 months. Changes to the bone level heights were measured at 6 and 12 months by two blinded examiners using the ImageJ® software. The final cement-retained PFM crown (DSIGN porcelain) was delivered at 12 months.
ANOVA was used to compare the mean implant stabilities between the three groups. Post hoc testing was done via Tukey’s honestly significant differences test to calculate the differences between ISQ measurements at the time of implant placement, 6 weeks and 6 and 12 months (Fig. 2) as well as bone levels at 6 and 12 months (Fig. 3). The correlations of multiple parameters such as insertion torque, ISQ, and crestal bone level were calculated using the Pearson product-moment correlation coefficient.
Serial posts:
- Comparative evaluation of the stability of two different dental implant designs and surgical protocols—a pilot study
- Background : Comparative evaluation of the stability of two different dental implant designs and surgical protocols—a pilot study (1)
- Background : Comparative evaluation of the stability of two different dental implant designs and surgical protocols—a pilot study (2)
- Methods : Comparative evaluation of the stability of two different dental implant designs and surgical protocols—a pilot study
- Results : Comparative evaluation of the stability of two different dental implant designs and surgical protocols—a pilot study
- Discussion : Comparative evaluation of the stability of two different dental implant designs and surgical protocols—a pilot study
- Figure 1. Implant design
- Table 1 Patient selection criteria
- Figure 2. ISQ values at placement, 6 weeks, 6 months, and 1 year
- Figure 3. Mean bone loss at 6 months and 1 year
- Table 2 Outcome success criteria