Dental ImplantNCT06286566
Soi TS3 Surface in Patients With and Without Type 2 Diabetes
A study testing Implant placement with soi surface in diabetic subjects and Implant placement with soi surface in healthy subjects in people with Dental Implant and Dental Implant-Abutment Design, run by Università degli Studi di Sassari at 1 site in Italy.
Trial summary
The aim of this prospective cohort study is to compare clinical and radiographic data of Osstem implants with SOI surface placed in patients with or without diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant, Dental Implant-Abutment Design
- What is being tested?
- Implant placement with soi surface in diabetic subjects and Implant placement with soi surface in healthy subjects
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 31 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of at least 18 years old able to sign an informed consent.
- Patients with at least a single tooth loss in the maxilla or mandible. Patient will provide only one site for the research. Implant sites must allow the placement of implants of at least 3.5 mm (upper laterals and lower incisors); 4 mm (central incisors, canines, and premolars) or 4.5 (molars) mm of diameter and at least 7 mm of length.
- Smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day).
- Patients with a plaque index (PI) of less than, or equal to 25% at the time of surgery.
- In case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study.
- Only in the test group, patients with controlled type 2 diabetes mellitus with at least 2 years of disease evaluation of HbA1C values between 6% and 10 % at the time of implant placement will be included.
- Only in the control group, healthy patients without any sign of type 2 diabetes mellitus will be included
Who cannot join
- General contraindications to implant surgery (except for type two diabetes in test group).
- Patients irradiated in the head and neck area.
- Immunosuppressed or immunocompromised patients (except for type two diabetes in test group).
- Patients treated or under treatment with intravenous amino-bisphosphonates.
- Patients with untreated periodontitis.
- Patients with poor oral hygiene and motivation.
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- Previous guided bone reconstruction at the intended implant sites.
- Uncontrolled diabetes (except for type two diabetes in test group).
- Pregnancy or nursing.
- Substance abuser.
- Psychiatric problems or unrealistic expectations.
- Lack of opposite occluding dentition in the area intended for implant placement.
- Patients with infection and or inflammation in the area intended for implant placement.
- Patients participating in other studies, if the present protocol cannot be properly adhered to.
- Patients referred only for implant placement and cannot be followed ant the treating centre.
- Patients unable to be followed for 5 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Osstem TS3 With SOI Surface in Patients With and Without Type 2 Diabetes: A Multicenter Prospective Cohort Study
The aim of this prospective cohort study is to compare clinical and radiographic data of Osstem implants with SOI surface placed in patients with or without diabetes.
- Conditions
- Dental Implant, Dental Implant-Abutment Design
- Being tested
- Implant placement with soi surface in diabetic subjects, Implant placement with soi surface in healthy subjects
- Keywords
- Dental Implant, Diabetics Patients, SOI Surface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant placement with soi surface in diabetic subjectsDevice
Implants placement with SOI surface in subjects with diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. After osseointegration implants will receive definitive prosthesis.
Implant placement with soi surface in healthy subjectsDevice
Implants placement with SOI surface in subjects without diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. After osseointegration implants will receive definitive prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Diabetics group | Experimental | Group of subjects with diabetes who will be inserted implants with a new implant surface called SOI Receives: Device: Implant placement with soi surface in diabetic subjects |
| Healthy Group | Active comparator | Group of helthy subjects who will be inserted implants with a new implant surface called SOI to compare them with the group of diabetic subjects Receives: Device: Implant placement with soi surface in healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of prosthesis failure:
whether it will not be possible to place the prosthesis because of implant failure or a prosthesis that has to be remade for any reason
Measured: Up to 5 years
Number of implant failure
defined as implant mobility and/or any infection dictating implant removal, and/or implant fracture and/or any other mechanical complication rendering the implant unusable.
Measured: Up to 5 years
Number of complication
Technical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, suppuration, peri-implantitis, etc.) complication will be considered
Measured: Up to 5 years
Secondary outcomes (2)
Rate of peri-implant marginal bone level changes
eri-implant marginal bone level changes will be assessed on periapical radiographs took with the paralleling technique at implant placement, at initial loading, 1,3 and 5 years after loading. Ideally digital radiographs should be taken, otherwise radiographs on conventional films will be scanned into TIFF format with a 600 dpi resolution, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the first two consecutive threads. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. Bone levels will be measured
Measured: At 1,3 and 5 years
Valuation of patient satisfaction
Patients will answer the following questions (separately for each implant):
Are you satisfied with the function of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not.
Are you satisfied with the aesthetic outcome of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not.
Would you undergo the same therapy again? Possible answers: "yes" or "no
Measured: At 1,3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter prospective cohort study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Collaborators
- Melodia, Dario, M.D., Pisano, Milena, M.D., Dr. Aurea M. I. Lumbau, Meloni, Silvio Mario, M.D., Baldoni, Edoardo, M.D.
- Responsible party
- Principal investigator, Marco Tallarico, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286566
- Sponsor's protocol ID
- UNISS_PHD_Osstem_2
- Status last verified
- Feb 2024
- First submitted
- 24 Apr 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Osstem TS3 With SOI Surface in Patients With and Without Type 2 Diabetes: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06286566
- Acronym / sponsor ID
- UNISS_PHD_Osstem_2
- Conditions
- Dental Implant, Dental Implant-Abutment Design
- Keywords
- Dental Implant, Diabetics Patients, SOI Surface
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Collaborators
- Melodia, Dario, M.D., Pisano, Milena, M.D., Dr. Aurea M. I. Lumbau, Meloni, Silvio Mario, M.D., Baldoni, Edoardo, M.D.
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 29 Feb 2024 (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 prospective cohort study is to compare clinical and radiographic data of Osstem implants with SOI surface placed in patients with or without diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Diabetics group | Experimental | Device: Implant placement with soi surface in diabetic subjectsGroup of subjects with diabetes who will be inserted implants with a new implant surface called SOI |
| Healthy Group | Active comparator | Device: Implant placement with soi surface in healthy subjectsGroup of helthy subjects who will be inserted implants with a new implant surface called SOI to compare them with the group of diabetic subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of at least 18 years old able to sign an informed consent.
- Patients with at least a single tooth loss in the maxilla or mandible. Patient will provide only one site for the research. Implant sites must allow the placement of implants of at least 3.5 mm (upper laterals and lower incisors); 4 mm (central incisors, canines, and premolars) or 4.5 (molars) mm of diameter and at least 7 mm of length.
- Smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day).
- Patients with a plaque index (PI) of less than, or equal to 25% at the time of surgery.
- In case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study.
Key exclusion criteria (16 listed)
- General contraindications to implant surgery (except for type two diabetes in test group).
- Patients irradiated in the head and neck area.
- Immunosuppressed or immunocompromised patients (except for type two diabetes in test group).
- Patients treated or under treatment with intravenous amino-bisphosphonates.
- Patients with untreated periodontitis.
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 |
|---|---|---|
| Implant placement with soi surface in diabetic subjectsImplants placement with SOI surface in subjects with diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. After osseointegration implants will receive definitive prosthesis. | Device | Diabetics group |
| Implant placement with soi surface in healthy subjectsImplants placement with SOI surface in subjects without diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. After osseointegration implants will receive definitive prosthesis. | Device | Healthy Group |
Primary outcome
Number of prosthesis failure:
Time frame: Up to 5 years
whether it will not be possible to place the prosthesis because of implant failure or a prosthesis that has to be remade for any reason
Number of implant failure
Time frame: Up to 5 years
defined as implant mobility and/or any infection dictating implant removal, and/or implant fracture and/or any other mechanical complication rendering the implant unusable.
Number of complication
Time frame: Up to 5 years
Technical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, suppuration, peri-implantitis, etc.) complication will be considered
2 secondary outcomes
Rate of peri-implant marginal bone level changes
Time frame: At 1,3 and 5 years
Valuation of patient satisfaction
Time frame: At 1,3 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant placement with soi surface in diabetic subjects and Implant placement with soi surface in healthy subjects in people with Dental Implant and Dental Implant-Abutment Design, run by Università degli Studi di Sassari at 1 site in Italy.
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 16 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: opening soon, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of prosthesis failure: (time frame: Up to 5 years). The study lists 3 primary outcomes in all. 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 29 Feb 2024.