Dental ImplantNCT06276712
RCT Comparing KS Versus TS for Ovedenture
A study testing Implant placement with 3.5 mm diameter KS implants. and Implant placement with 3.5 mm diameter TS implants. in people with Dental Implant and Dental Implant-Abutment Design, run by Università degli Studi di Sassari.
Trial summary
To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants 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, Edentulous Jaw
- What is being tested?
- Implant placement with 3.5 mm diameter KS implants. and Implant placement with 3.5 mm diameter TS implants.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 30 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
- Any edentulous patient (post-extractive sites must to be healed from at least 3 months), with sufficient bone height and width in the anterior mandible (between canines) to allow the placement of two implants of 3.5 mm diameter of at least 8.5 mm of length.
- 18 years or older, and able to sign an informed consent.
- 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).
- In case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study.
Who cannot join
- General contraindications to implant surgery.
- Patients irradiated in the head and neck area.
- Immunosuppressed or immunocompromised patients.
- 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.
- 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.
About this study
Official title: A Randomized Controlled Trial Comparing Titanium Grade V (KS) Versus Titanium Grade IV (TS) Implants for the Treatment of Edentulous Mandible
To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants
- Being tested
- Implant placement with 3.5 mm diameter KS implants., Implant placement with 3.5 mm diameter TS implants.
- Keywords
- Dental Implant, Overdenture, Implant-abutment connection
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant placement with 3.5 mm diameter KS implants.Device
Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants. with 3.5 mm diameter KS implants.After osseointegration, both dental implants will receive definitive prosthesis.
Implant placement with 3.5 mm diameter TS implants.Device
Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants. with 3.5 mm diameter TS implants.After osseointegration, both dental implants will receive definitive prosthesis.
| Study group | Role | What they receive |
|---|---|---|
| Ks dental implant | Experimental | Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants using KS implant with 3.5 mm of diameter Receives: Device: Implant placement with 3.5 mm diameter KS implants. |
| TS dental implant | Active comparator | Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants using TS implant with 3.5 mm of diameter Receives: Device: Implant placement with 3.5 mm diameter TS implants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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 reaso
Measured: Up to 5 years
Number of complications
echnical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, suppuration, peri-implantitis, etc.) complications will be considered.
Measured: Up to 5 years
Rate of implant stability
The stability of each individual implant will be measured by the local blinded outcome assessors manually tightening the screws with a torque of 30 Ncm at abutment connection at initial loading. At 1,3 and 5 years after loading, individual implants will be manually tested for stability. Once the single crowns will be screwed, their stability will be assessed by rocking the crown with the handles of two dental instruments.
Measured: Up to 5 years
Secondary outcomes (2)
Peri-implant marginal bone level changes
Peri-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
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 posted26 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenters, randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 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 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
- NCT06276712
- Sponsor's protocol ID
- UNISS_PHD_Osstem_5
- Status last verified
- Feb 2024
- First submitted
- 24 Apr 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Titanium Grade V (KS) Versus Titanium Grade IV (TS) Implants for the Treatment of Edentulous Mandible
- ClinicalTrials.gov ID
- NCT06276712
- Acronym / sponsor ID
- UNISS_PHD_Osstem_5
- Keywords
- Dental Implant, Overdenture, Implant-abutment connection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Collaborators
- Melodia, Dario, M.D., Pisano, Milena, M.D., Dr. Aurea Lumbau, Meloni, Silvio Mario, M.D., Baldoni, Edoardo, M.D.
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 26 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.
To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A multicenters, randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Ks dental implant | Experimental | Device: Implant placement with 3.5 mm diameter KS implants.Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants using KS implant with 3.5 mm of diameter |
| TS dental implant | Active comparator | Device: Implant placement with 3.5 mm diameter TS implants.Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants using TS implant with 3.5 mm of diameter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any edentulous patient (post-extractive sites must to be healed from at least 3 months), with sufficient bone height and width in the anterior mandible (between canines) to allow the placement of two implants of 3.5 mm diameter of at least 8.5 mm of length.
- 18 years or older, and able to sign an informed consent.
- 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).
- 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.
- Patients irradiated in the head and neck area.
- Immunosuppressed or immunocompromised patients.
- 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 3.5 mm diameter KS implants.Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants. with 3.5 mm diameter KS implants.After osseointegration, both dental implants will receive definitive prosthesis. | Device | Ks dental implant |
| Implant placement with 3.5 mm diameter TS implants.Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants. with 3.5 mm diameter TS implants.After osseointegration, both dental implants will receive definitive prosthesis. | Device | TS dental implant |
Primary outcome
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 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 reaso
Number of complications
Time frame: Up to 5 years
echnical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, suppuration, peri-implantitis, etc.) complications will be considered.
Rate of implant stability
Time frame: Up to 5 years
The stability of each individual implant will be measured by the local blinded outcome assessors manually tightening the screws with a torque of 30 Ncm at abutment connection at initial loading. At 1,3 and 5 years after loading, individual implants will be manually tested for stability. Once the single crowns will be screwed, their stability will be assessed by rocking the crown with the handles of two dental instruments.
2 secondary outcomes
Peri-implant marginal bone level changes
Time frame: At 1,3 and 5 years
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 26 Feb 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Implant placement with 3.5 mm diameter KS implants. and Implant placement with 3.5 mm diameter TS implants. in people with Dental Implant and Dental Implant-Abutment Design, run by Università degli Studi di Sassari.
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 4 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 26 Feb 2024. 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?
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 implant failure (time frame: Up to 5 years). The study lists 4 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 26 Feb 2024; AzTrials last refreshed its copy on 31 Oct 2026.