Dental ImplantNCT06286579
SOI Immediately vs Delayed
A study testing Immediately implant placement and Delayed 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 randomized controlled trial is to compare the clinical and radiographic of immediately loaded, immediate (post-extractive, test group) versus delayed (control group) implants with new SOI surface 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?
- Immediately implant placement and Delayed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 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
- Any patient with at least one hopeless tooth in the mandible or maxilla, located between premolars, with intact post extractive alveolus. The implants must to engage at least 3 (mandible) to 5 (maxilla) mm of residual native bone over the socket.
- Patients with 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). Heavy smokers will be excluded.
- Biotype will be categorized in thin (≤1 mm), medium (>1 - <2 mm) or thick (≥2 mm).
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.
Show all 16Show fewer
- Uncontrolled diabetes.
- Heavy smokers.
- 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: The Efficacy of New SOI Implant Surface for Immediately Loaded, Post-extractive Versus Delayed Implants
The aim of this randomized controlled trial is to compare the clinical and radiographic of immediately loaded, immediate (post-extractive, test group) versus delayed (control group) implants with new SOI surface
- Conditions
- Dental Implant, Dental Implant-Abutment Design
- Being tested
- Immediately implant placement, Delayed
- Keywords
- Dental Implant, Immediately vs Delayes, Implant-abutment connection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediately implant placementDevice
After atraumatic tooth extraction immediate implant placement with SOI surface and loading will be performed with temporary restoration. After osseointegration (8 weeks), the temporary restoration will be modified according to the soft tissue management. After 3 to 4 months, a definitive digital or analog impression will be taken and later definitive restoration will be delivered
DelayedDevice
After atraumatic tooth extraction, the extraction site will be left to heal for 4 months, just grafting with A-Oss and suture, according to a socket preservation procedure. Four month later, implant will be place and immediate loadind with temporary restoration will be performed.
After osseointegration (8 weeks), the temporary restoration will be modified according to the soft tissue management. After 3 to 4 months, a definitive digital or analog impression will be taken and later definitive restoration will be delivered
| Study group | Role | What they receive |
|---|---|---|
| Immediately implant placement | Experimental | Atraumatic tooth extraction and immediately placement of implant with a new surface Receives: Device: Immediately implant placement |
| Delayed implant placement | Active comparator | Atraumatic tooth extraction, after the site will be left to heal for 4 months, just grafting with A-Oss and suture, according to a socket preservation procedure. Four month later, implant will be place Receives: Device: Delayed |
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. 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, immediately loading, at 1,3 and 5 years after loading for the partial fixed prostheses. Once the single crowns will be cemented, their stability will be assessed by rocking the crown with the handles of two dental instruments.
Measured: Up to 5 years
Number of complications
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 (5)
Rate of 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
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
Rate of implant stability quotient (ISQ)
ISQ was measured and recorded using the IS3 (Osstem), at implant placement, at implants exposure, at the impression time, and prosthetic loading.
Measured: Up to 5 years
Valuation of soft tissue thickness and amount of keratinized tissue
The soft tissue biotype will be investigated by the same surgeon at the surgical procedures using a periodontal probe into the sulcus. Greater will be the thickness of the tissue, smaller will be transparency of the periodontal probe. The amount of keratinized tissue will be evaluated 1 year after surgical procedures using a periodontal probe. This outcome will be evaluated according to the distance from the gingival margin to the mucogingival junction
Measured: 1,3 and 5 years
Number of PES score
Esthetic evaluation of occlusal and vestibular pictures will take every years after definite loading was done following the pink esthetic score (PES). In brief, the PES score evaluates seven variables: mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiencies, soft tissue color and texture. A 0-1-2 scoring system was used, 0 being the lowest and 2 being the highest value, with a maximum achievable score of 14 per dental unit.
Measured: 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial of parallel group design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 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
- NCT06286579
- Sponsor's protocol ID
- UNISS_PHD_Osstem_3
- 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
- The Efficacy of New SOI Implant Surface for Immediately Loaded, Post-extractive Versus Delayed Implants
- ClinicalTrials.gov ID
- NCT06286579
- Acronym / sponsor ID
- UNISS_PHD_Osstem_3
- Conditions
- Dental Implant, Dental Implant-Abutment Design
- Keywords
- Dental Implant, Immediately vs Delayes, Implant-abutment connection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 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 randomized controlled trial is to compare the clinical and radiographic of immediately loaded, immediate (post-extractive, test group) versus delayed (control group) implants with new SOI surface
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled trial of parallel group design.
| Arm | Type | Receives |
|---|---|---|
| Immediately implant placement | Experimental | Device: Immediately implant placementAtraumatic tooth extraction and immediately placement of implant with a new surface |
| Delayed implant placement | Active comparator | Device: DelayedAtraumatic tooth extraction, after the site will be left to heal for 4 months, just grafting with A-Oss and suture, according to a socket preservation procedure. Four month later, implant will be place |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any patient with at least one hopeless tooth in the mandible or maxilla, located between premolars, with intact post extractive alveolus. The implants must to engage at least 3 (mandible) to 5 (maxilla) mm of residual native bone over the socket.
- Patients with 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). Heavy smokers will be excluded.
- Biotype will be categorized in thin (≤1 mm), medium (>1 - <2 mm) or thick (≥2 mm).
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 |
|---|---|---|
| Immediately implant placementAfter atraumatic tooth extraction immediate implant placement with SOI surface and loading will be performed with temporary restoration. After osseointegration (8 weeks), the temporary restoration will be modified according to the soft tissue management. After 3 to 4 months, a definitive digital or analog impression will be taken and later definitive restoration will be delivered | Device | Immediately implant placement |
| DelayedAfter atraumatic tooth extraction, the extraction site will be left to heal for 4 months, just grafting with A-Oss and suture, according to a socket preservation procedure. Four month later, implant will be place and immediate loadind with temporary restoration will be performed. After osseointegration (8 weeks), the temporary restoration will be modified according to the soft tissue management. After 3 to 4 months, a definitive digital or analog impression will be taken and later definitive restoration will be delivered | Device | Delayed implant placement |
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. 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, immediately loading, at 1,3 and 5 years after loading for the partial fixed prostheses. Once the single crowns will be cemented, their stability will be assessed by rocking the crown with the handles of two dental instruments.
Number of complications
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.
5 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
Rate of implant stability quotient (ISQ)
Time frame: Up to 5 years
Valuation of soft tissue thickness and amount of keratinized tissue
Time frame: 1,3 and 5 years
Number of PES score
Time frame: 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
Related trials for Dental Implant
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Recruiting
Evaluation of Different Grafting Technique of Thin Gingival Phenotype With Delayed Dental Implants
Implant Dentistry, Connective Tissue Graft
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Not yet recruitingPhase 1/2
Effect of Povidone Iodine on the Dental Implant Internal Surface Microbiome
Dental Implant
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
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 Immediately implant placement and Delayed 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 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 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.