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Not yet recruitingNCT05979246Updated Aug 7, 2023

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

An interventional study of Lance CLEAR dental implant in Diabetes, sponsored by MIS Implant Technologies, Ltd. Not yet recruiting. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-07.

Sponsored by MIS Implant Technologies, Ltd · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

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.
Read the 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

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

MIS Implant Technologies, Ltd is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Diabetic patients

    undergo implant installation

    Device: Lance CLEAR dental implant

Interventions

  • DeviceLance 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

06

What researchers measure

Primary outcomes

  1. marginal bone loss

    radiographic bone resorption around the implant

    Time frame: one year after loading

Secondary outcomes

  1. Survival rate

    Implant stability measurements by Osstell.

    Time frame: 12 weeks after implantation

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05979246
Lead sponsor
MIS Implant Technologies, Ltd
Collaborators
Rambam Health Care Campus
Responsible party
Sponsor
First posted
Aug 7, 2023
Start date
Sep 1, 2023 (estimated)
Primary completion
Jan 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Aug 7, 2023

Study contacts

Michal Malka
Contact
michal.malka@dentsplysirona.com
+972-54-7257128
Liron Eliezer
Contact
l_eliezer@rambam.health.gov.il
+972-50-7735100

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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