DiabetesNCT05979246
Effect of the Superhydrophilic Surface of Lance CLEAR Implants on the Marginal Bone Loss and Survival in Diabetic and Non Diabetic Patients
A study testing Lance CLEAR dental implant in people with Diabetes, run by MIS Implant Technologies, Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Lance CLEAR dental implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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:
- 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).
- 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
- Conditions
- Diabetes
- Being tested
- Lance CLEAR dental implant
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lance CLEAR dental implantDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Diabetic patients | Experimental | undergo implant installation Receives: Device: Lance CLEAR dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
marginal bone loss
radiographic bone resorption around the implant
Measured: one year after loading
Secondary outcomes (1)
Survival rate
Implant stability measurements by Osstell.
Measured: 12 weeks after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MIS Implant Technologies, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979246
- Sponsor's protocol ID
- MIS Implants Technologies
- Status last verified
- Jul 2023
- First submitted
- 30 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05979246
- Acronym / sponsor ID
- MIS Implants Technologies
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- MIS Implant Technologies, LtdIndustry (pharma, biotech, devices)
- Collaborators
- Rambam Health Care Campus
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Diabetic patients | Experimental | Device: Lance CLEAR dental implantundergo implant installation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lance CLEAR dental implantThe 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 | Device | Diabetic patients |
Primary outcome
marginal bone loss
Time frame: one year after loading
radiographic bone resorption around the implant
1 secondary outcome
Survival rate
Time frame: 12 weeks after implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Lance CLEAR dental implant in people with Diabetes, run by MIS Implant Technologies, Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Malka (+972-54-7257128, michal.malka@dentsplysirona.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
marginal bone loss (time frame: one year after loading). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.