Stability of Implants Placed in Patients With Vitamin D Deficiency Using Sequential Drilling vs a Single Drilling Design
Sponsor:
Cairo University
Collaborators:
Information provided by (Responsible Party):
Ahmed Nabil Ahmed Younis，Cairo University
| Tracking Information | |||
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| First Submitted Date ICMJE | September 30, 2018 | ||
| First Posted Date ICMJE | October 4, 2018 | ||
| Last Update Posted Date | October 5, 2018 | ||
| Actual Study Start Date ICMJE | November 27, 2018 | ||
| Estimated Primary Completion Date | November 27, 2020 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
primary/secondary implant stability[ Time Frame: 6 months ] primary & secondary implant stability using ostell/periotest |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Stability of Implants Placed in Patients With Vitamin D Deficiency Using Sequential Drilling vs a Single Drilling Design |
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| Official Title ICMJE | Stability of Dental Implants Placed in Patients With Vitamin D Deficiency Using Sequential Drilling Versus a New One Single Drilling Design: A Randomized Clinical Trial |
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| Brief Summary | - Vitamin D considers as the most potent effect on calcium level in blood it was found that vitamin D target mainly bone tissue intestine and kidney for calcium absorption In bone, vitamin D stimulates mainly the activity of osteoclasts osteoblast activity on the other hand it increases the production of extracellular matrix proteins by different osteoblastic activity. Vitamin D also increase intestinal calcium absorption and regulate synthesis and secretion of parathyroid hormone (PTH) Implant consider as one of the most successful treatment modalities that usually used in dental clinics for restoring single or multiple missed teeth knowing that successful rate of dental implant may reach up to 99% however there are many different techniques for implant placement they mainly depend on the same procedure for implant placement even sequential drilling technique or single drilling technique some paper supported that sequential drilling is much better than single drilling technique on other hand some assume that single drilling is much better as it save time effort material less bone trauma & less heat generation although there are many studies performed on sequential drilling & single drilling techniques we still have a gap for understanding the ideal technique for implant placement in patients with vitamin D deficiency |
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| Detailed Description | The high predictability of dental implants has led to routine use with a great expectation for success There are many researches focused on the outcome of delayed dental implant Since the first report of highly success rate after placement of a dental implant there has been increasing interest in this technique for implant treatment The goal of modern dentistry is to restore the patient's dentition to normal contour function comfort esthetics speech and health regardless of the atrophy disease or injury of the stomatognathic system As a result of disease related tooth loss and the value placed upon teeth there has been a continual search for methods by which missing teeth could be replaced Early artificial replacements were made from natural teeth and a variety of substitute materials All transplantation of a tooth from one person to another was an early method by which lost teeth were replaced Archeological discoveries indicate that many ancient civilizations practiced allogenic tooth transplantation. In 1561 Ambrose Pare reported that decayed teeth could be replaced by using extracted teeth from another individual and is credited with being the first to mention transplantation The core objective of dental implant therapy is to improve functional dentition throughout life Nevertheless there are many factors that may effect on implant stability A significant part of implant failure may be related to systemic condition that my retard dental implants osteointegration one of this factors is vitamin D deficiency recently many paper focused on vitamin D deficiency and its impact effect on bone turn over around dental implant There are many different techniques for implant placement even sequential drilling or single drilling technique knowing that single drilling technique has a compression effect which may enhance implant stability however sequential drilling don't have compression effect on bone some paper supported that sequential is much better than single drilling technique however some paper showed there is no clinical significance between two techniques the main idea here that we need to find an ideal technique for implant placement in patients with vitamin D deficiency knowing that vitamin D play an important role for bone turnover around dental implant to attain the required dental implant stability also play a role for osteoblast osteoclast activity Also vitamin D play a role for regulation of parathyroid hormone which play a role for homeostasis of calcium level from bone in blood . | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 4 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description:double blinded Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
20 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | March 27, 2021 | ||
| Estimated Primary Completion Date | November 27, 2020 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion criteria: 1. Age: 18-70. 2. Patient with vitamin D deficiency ( >30 ng/ml ) 3. Patients with single or multiple missed teeth in upper & lower molar premolar area. 4. Patients with adequate bone volume for the dental implant procedure. 5. Patient with sufficient interarch space. 6. Patients who are compliant to oral hygiene measures. 7. Patient consent approval and signing. Exclusion criteria: 1. Systemic disease that contraindicates implant placement or surgical procedures. 2. Poor patient's compliance. 3. Psychological problems. 4. Pathology at the site of intervention. | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
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| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Ahmed Nabil Ahmed Younis，Cairo University | ||
| Study Sponsor ICMJE | Cairo University | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Cairo University | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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