Status:
UNKNOWN
Effect of the Superhydrophilic Surface of Lance CLEAR Implants on the Marginal Bone Loss and Survival in Diabetic and Non Diabetic Patients
Lead Sponsor:
MIS Implant Technologies, Ltd
Collaborating Sponsors:
Rambam Health Care Campus
Conditions:
Diabetes
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The aim of this clinical, prospective study involving implants with a superhydrophilic surface is to compare the changes of the peri-implant tissues and the survival rate between diabetics and non-dia...
Detailed Description
In recent years, our understanding of the primary processes that affect bone growth around implants has progressed. It was found that the standard surface of most implants is not hydrophilic enough; t...
Eligibility Criteria
Inclusion
- Ages ≥18.
- A properly signed and dated consent form.
- The need to perform a dental implant (up to two dental implants will be selected for the patient).
- The existence of sufficient alveolar bone that allows the installation of implants of standard size (diameter 3.75 or above and height of at least 8 mm).
- Patients who will receive a fixed restoration (a crown or three units bridge)
- A type 2 diabetes with 10 \> A1C\>7.5 % values but not above 10, or non-diabetic patient (control).
- Meeting the study schedules and attending the study visits.
Exclusion
- The presence of an active periodontal disease (PD≥6 mm with bleeding on probing).
- Smoking more than 10 cigarettes a day.
- Pharmacological condition which can affect the healing of soft or hard tissue.
- Past radiation therapy to the head and neck.
- Patients under medications with known effects on bone metabolism (e.g. steroids, anti-TNF-α), antibiotics therapy in the previous months.
- Impaired occlusion that can lead to pathologies.
- Pregnancy and lactating.
- A patient who needs local bone augmentation.
- Using removable prosthesis in the implantation area.
- Subjects who are currently enrolled, recently participated (within 30 days prior to screening), or planning to enroll in another study that may conflict with protocol requirements or may confound the subject results in this trial.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05979246
Start Date
September 1 2023
End Date
September 1 2025
Last Update
August 7 2023
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