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

NCT05979246 | Unknown

• 1 other identifier: MIS Implants Technologies
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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-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

Diabetes

Outcome Measures

Primary Outcomes (1)

• marginal bone loss

  radiographic bone resorption around the implant

  one year after loading

Secondary Outcomes (1)

• Survival rate

  12 weeks after implantation

Study Arms (1)

Diabetic patients

EXPERIMENTAL

undergo implant installation

Device: Lance CLEAR dental implant

Interventions

Lance CLEAR dental implant DEVICE

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

Diabetic patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MIS Implant Technologies, Ltd: lead
• Rambam Health Care Campus: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Michal Malka

CONTACT

+972-54-7257128; michal.malka@dentsplysirona.com

Liron Eliezer

CONTACT

+972-50-7735100; l_eliezer@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 40 patients who are planned to undergo implant installation will be enrolled in the study, at the department of Periodontology at the School of postgraduate dentistry in the Rambam Health Care Center. 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.

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 7, 2023
• Study Start: September 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 7, 2023

Record last verified: 2023-07