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

A Comparative Prospective Study to Evaluate the Effect of the Superhydrophilic Surface of Lance CLEAR Implants on the Marginal Bone Loss and Survival in Diabetic and Non Diabetic Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes
• Intervention / Treatment: Device: Lance CLEAR dental implant

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; therefore, it is necessary to increase the healing time to allow sufficient bony apposition at the implant interface, until reaching a satisfactory load-bearing capacity. Studies have demonstrated that surface superhydrophilicity can be gained following storage in an isotonic solution (NaCl); this feature leads to an earlier bone apposition and higher anchorage, already after the very first weeks of implantation.

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.

Aim:to compare the changes of the peri-implant tissues and the survival rate between diabetics and non-diabetics patients, after 12 months of loading.

Methods and Materials: 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. Visit 0 - Screening Visit 1 - Surgical procedure (± 8 weeks)

After insertion of the implants, the following surgical indicators will be taken:

1. Stability of the implants will be measured using an Osstell device with a fitted peg screwed into the implant neck; unit is given as an arbitrary implant stability quotient (ISQ).
2. Register bone quality type 1-4 according to the doctor report using Bone classification of Lekholm & Zarb ,1985.

Visit 2 - suture removal (10 ±3days) Visit 3 (surgical uncovering) 12 weeks after implantation (±8 weeks) Visit 4 (follow-up) 16 weeks after implantation (± 8 weeks) :this visit includes periodontal examination (PD, BOP, PI, GI) and GCF sampling.

Visit 5 ( Follow up ) 12 months after rehabilitation (± 4 weeks) :Clinical and radiographic assessment of the periimplant mucosa

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michal Malka; Phone Number: +972-54-7257128; Email: michal.malka@dentsplysirona.com
• Study Contact Backup: Name: Liron Eliezer; Phone Number: +972-50-7735100; Email: l_eliezer@rambam.health.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Ages ≥18.
2. A properly signed and dated consent form.
3. The need to perform a dental implant (up to two dental implants will be selected for the patient).
4. 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).
5. Patients who will receive a fixed restoration (a crown or three units bridge)
6. A type 2 diabetes with 10 > A1C>7.5 % values but not above 10, or non-diabetic patient (control).
7. Meeting the study schedules and attending the study visits.

Exclusion Criteria:

1. The presence of an active periodontal disease (PD≥6 mm with bleeding on probing).
2. Smoking more than 10 cigarettes a day.
3. Pharmacological condition which can affect the healing of soft or hard tissue.
4. Past radiation therapy to the head and neck.
5. Patients under medications with known effects on bone metabolism (e.g. steroids, anti-TNF-α), antibiotics therapy in the previous months.
6. Impaired occlusion that can lead to pathologies.
7. Pregnancy and lactating.
8. A patient who needs local bone augmentation.
9. Using removable prosthesis in the implantation area.
10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diabetic patients; undergo implant installation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal bone loss	radiographic bone resorption around the implant	one year after loading

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rate	Implant stability measurements by Osstell.	12 weeks after implantation

Collaborators and Investigators

• Sponsor: MIS Implant Technologies, Ltd
• Collaborators: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MIS Implants Technologies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No