Stability Of Dental Implants Placed In Healed Bony Sites Of Hyperlipidemic Patients: A Case Series (NCT04718246) | Clinical Trial Compass
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Stability Of Dental Implants Placed In Healed Bony Sites Of Hyperlipidemic Patients: A Case Series
Egypt12 participantsStarted 2020-06-01
Plain-language summary
Statement of the problem:
Osseo-integration of dental implants depends mainly on bone regeneration around dental implant. Hyperlipidemia has significant adverse effects on bone health, leading to lower bone mineral density and to higher risk of osteoporosis and bone fracture (Corwin 2003; Pirih, Lu et al. 2012). The effects of hyperlipidemia on bone health may also interfere with dental implant therapy since the host's bone quantity, quality and healing potential play an important role in osseointegration (Fedele, Sabbah et al. 2011; Gaetti-Jardim, Santiago-Junior et al. 2011; Olivares-Navarrete, Raines et al. 2012).
Rationale for conducting the research:
Hyperlipidemia has been associated with the pathophysiology of major diseases, such as atherosclerosis and osteoporosis.
A high cholesterol level has significant adverse effects on bone, including lower bone density, volume and strength. Statins, drugs that lower serum cholesterol levels have beneficial effects on bone metabolism. Since host's bone quantity, quality and healing potential play a crucial role in osseointegration of dental implants, it was hypothesized that hyperlipidemia may negatively affect implant osseointegration.
Who can participate
Age range
20 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients who have at least one missing tooth.
* Patient with hyperlipidemia (LDL \< 160 mg/dl )
* Patients with sufficient interarch space.
* Patients aged from 20 to 60 years old.
* Good oral hygiene.(Wiesner et al. 2010)
* Accepts 6 months follow-up period (cooperative patients)
* Patient provides an informed consent.
Exclusion Criteria:
Patients with signs of acute infection related to the area of interest.
* Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits (Lobbezoo et al. 2006).
* Current and former smokers (Lambert et al, 2000)
* Pregnant women.
* Psychological problems -
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Implant stability
Timeframe: At time of implant placement, 6 months post-implant placement