Evaluation of the Related Factors Influencing the Stability of Dental Implants

Study Overview
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Brief Summary
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With the development of oral medicine,dental implants has become a very popular solution to remediate the loss of teeth and dental rehabilitation. For the last few decades, the immediate loading protocol have become more and more popular because the increasing demands of shortened treatment time. Implant stability is considered one of the most important parameters in implant dentistry. It affects the healing and successful osseointegration of implants. For any implant procedure, successful implant integration is a prerequisite criterion, which depends on a series of procedure-related and patient-dependent factors. It also has been considered that preoperative measurement is critical and may give valuable information to predict loading time and survival of the implants. In this clinical study, the samples were collected from patients with single teeth missing who came from the department of prosthodontics from the School of Stomatology of the Fourth Military Medical University.The prospective cohort study was used to investigate the correlation between different factors and the early stability of the implants. And then, using the correlation between different factors and the early implant stability gives predictable data about implant stability and then evaluate the accuracy and reliability.

Detailed Description
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Ethical and institutional approval was obtained from the study institution. From May 2015 to May 2017, teeth missing consecutive patients requiring implant treatment consented to participate in this study to investigate the correlation between implant stability and bone density. Cone beam computed tomography (CBCT) was used for preoperative radiological evaluation of the jawbone for each patient, and then bone density in Houndsfield units scale was assessed by SimPlant Pro 11.04 software. Immediately after the implant placement and 12 weeks later, stability measurements were performed with Osstell™ Mentor.The captured data was represented in a quantitative unit called Implant Stability Quotient (ISQ) on a scale from 1 to 100 and averaged for each implant. The descriptive statistical methods were used to show the differences in bone density and ISQ values among location, gender, age and implant diameter variables. Mann-whitney test was used for comparison of HU values and ISQ values between different age and gender groups. Kruskal-Wallis test was used for comparison of HU values and ISQ values between different location and implant diameter groups. The changes of ISQ values over time were compared using Wilcoxon signed rank test. The Spearman's rank correlation coefficient was used to investigate the correlation between ISQ values and HU values. At last, to investigate the possible correlations between implant stability and bone density and to study the feasibility of predicting implant stability by using preoperative CBCT.

Official Title
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Evaluation of the Related Factors Influencing the Stability of Dental Implants

Conditions
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Teeth Missing

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the patients who had undergone tooth extraction within the previous 3 months Exclusion Criteria: those who required bone augmentation simultaneously with implant insertion, and patients with any systemic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant stability quotient (ISQ) was tested by Osstell™ Mentor | The transducer probe was aimed at the small magnet on top of the SmartPeg at a distance of 2 to 3 mm and held stable during the pulsing time until the instrument beeped and displayed the ISQ value. If two ISQ values were displayed simultaneously, their mean value was recorded. Measurements were taken twice in the buccolingual direction as well as in the mesiodistal direction. The mean of all measurements was rounded to the nearest whole number and was regarded as representative of the ISQ. | on the day of surgery | 
| Implant stability quotient (ISQ) was tested by Osstell™ Mentor | The transducer probe was aimed at the small magnet on top of the SmartPeg at a distance of 2 to 3 mm and held stable during the pulsing time until the instrument beeped and displayed the ISQ value. If two ISQ values were displayed simultaneously, their mean value was recorded. Measurements were taken twice in the buccolingual direction as well as in the mesiodistal direction. The mean of all measurements was rounded to the nearest whole number and was regarded as representative of the ISQ. | on the 12th weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the bone density of the implant locations by CBCT. | Using the interactive setting on the SimplantTM software, an implant was then placed over the alveolar portion of each edentulous span to include the trabecular portion and the outer cortical shell when present. The computer was then asked to map the density of the bone around the entire circumference of each implant, with a surrounding thickness of 1 mm, which is the default setting . Multiple adjacent readings were taken within each span, where possible. Subsequently, all areas subjectively classified into each of the four qualities were pooled so that a range of Houndsfield values (HU) could be attributed to each particular quality, and a mean value was calculated in order to establish a new objective quantitative scale of bone density. | within 10 days before surgery | 
| Measure the thickness of the bone around the implant by CBCT. | Using the interactive setting on the SimplantTM software, an implant was then placed over the alveolar portion of each edentulous span to include the trabecular portion and the outer cortical shell when present. The computer was then asked to map the density of the bone around the entire circumference of each implant, with a surrounding thickness of 1 mm, which is the default setting . Multiple adjacent readings were taken within each span, where possible. Subsequently, all areas subjectively classified into each of the four qualities were pooled so that a range of Houndsfield values (HU) could be attributed to each particular quality, and a mean value was calculated in order to establish a new objective quantitative scale of bone density. | immediately after the surgery | 
| Measure the crestal bone resorption by X-ray images | The transducer probe was aimed at the small magnet on top of the SmartPeg at a distance of 2 to 3 mm and held stable during the pulsing time until the instrument beeped and displayed the ISQ value. If two ISQ values were displayed simultaneously, their mean value was recorded. Measurements were taken twice in the buccolingual direction as well as in the mesiodistal direction. The mean of all measurements was rounded to the nearest whole number and was regarded as representative of the ISQ. | immediately and 3 months after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implant, stability, implant stability quotient