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Effect of the Superhydrophilic Surface of Lance CLEAR Implants on the Marginal Bone Loss and Survival in Diabetic and Non Diabetic Patients

NCT05979246 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-08-07

No results posted yet for this study

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-diabetics patients, after 12 months of loading.

hypothesis: It is not expected to find any short-term differences in failures and marginal bone loss between the diabetic and non-diabetic patients. On the longer term higher marginal bone loss may affect the diabetic group 40 patients who are planned to undergo implant installation will be enrolled in the study.

The patients will be divided into 2 groups:

* Test group - 20 patients diagnosed with type 2 diabetes with 10\>HbA1C\>7.5% values
* Control group - 20 non-diabetic patients.

Conditions

Interventions

DEVICE

Lance CLEAR dental implant

The surgical procedure will be performed by experienced periodontists, all implants will be at least Ø 3.75 mm and 8-11.5 mm long. After reflecting the flaps, a bone biopsy will be harvested as part of the drilling procedure using a Ø 2.4 mm trephine drill and the implants will be seated into a crestal position

Sponsors & Collaborators

  • Rambam Health Care Campus

    collaborator OTHER

  • MIS Implant Technologies, Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-01-01
Completion
2025-09-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05979246 on ClinicalTrials.gov