Bone HealingNCT06711744
ISQ Differences Between Different Implants in Post-extraction Sockets
A study testing Implant stability quotient in people with Bone Healing and Implant Stability, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
Two different implants will be used in post-extraction sockets and ISQ will be recorded monthly from insertion moment to 12 months of follow up to understand if ISQ can be affected by implant macro design Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Healing, Implant Stability
- What is being tested?
- Implant stability quotient
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jan 2025to 28 Feb 2027
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients (at least 18 years old) presenting with failing tooth.
- no recession of gingival contour of tooth to be extracted
- no periodontal bone loss of neighboring teeth
- no implants in neighboring teeth
- class I extraction socket (intact buccal wall)
- atraumatic extraction of the tooth with intact socket walls remaining.
Who cannot join
- deep bite (severe II class)
- systemic disease (diabetes, osteoporosis)
- heavy smokers (more than 10 cigarettes/day)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Paolo Carosi
Rome, RM, 00133
Paolo Carosi, PhD, 3277998699, carosipaolo29@gmail.com
About this study
Official title: Effect of Time and Local Factors on Hydrophilic Tissue Level Implants in Post-extraction Sites: a RCT
Two different implants will be used in post-extraction sockets and ISQ will be recorded monthly from insertion moment to 12 months of follow up to understand if ISQ can be affected by implant macro design
- Conditions
- Bone Healing, Implant Stability
- Being tested
- Implant stability quotient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant stability quotientDiagnostic test
Screw a smart peg into the implant and record the values from a dedicated device
| Study group | Role | What they receive |
|---|---|---|
| TISSUE LEVEL X | Active comparator | Implants with aggressive macro design Receives: Diagnostic Test: Implant stability quotient |
| TISSUE LEVEL C | Experimental | Implants with less aggressive macro design Receives: Diagnostic Test: Implant stability quotient |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMPLANT STABILITY QUOTIENT
Values of risonance of implants taken by means of a dedicated device that translate the risonance of each implant into a number (0-99).
Measured: Monthly from T0 (implant insertion) to T12 (12 months after implant placement)
Secondary outcomes (1)
Insertion torque
Mechanical resistance of the bone at implant placement
Measured: At implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start31 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone HealingStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Carosi, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711744
- Sponsor's protocol ID
- TLCVSTLX
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carosi P, Laureti A, Alrmali A, Pinto A, Wang HL, Lorenzi C. Design Matters? Evaluating Implant Macro-Geometry in Immediate Implants: A Randomized Clinical Trial With Six-Month Interim Analysis. Clin Exp Dent Res. 2026 Oct;12(5):e70490. doi: 10.1002/cre2.70490.
PubMed 42927630
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time and Local Factors on Hydrophilic Tissue Level Implants in Post-extraction Sites: a RCT
- ClinicalTrials.gov ID
- NCT06711744
- Acronym / sponsor ID
- TLCVSTLX
- Conditions
- Bone Healing, Implant Stability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 31 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 2 Dec 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.
Two different implants will be used in post-extraction sockets and ISQ will be recorded monthly from insertion moment to 12 months of follow up to understand if ISQ can be affected by implant macro design
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TISSUE LEVEL X | Active comparator | Diagnostic Test: Implant stability quotientImplants with aggressive macro design |
| TISSUE LEVEL C | Experimental | Diagnostic Test: Implant stability quotientImplants with less aggressive macro design |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients (at least 18 years old) presenting with failing tooth.
- no recession of gingival contour of tooth to be extracted
- no periodontal bone loss of neighboring teeth
- no implants in neighboring teeth
- class I extraction socket (intact buccal wall)
Key exclusion criteria (3 listed)
- deep bite (severe II class)
- systemic disease (diabetes, osteoporosis)
- heavy smokers (more than 10 cigarettes/day)
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 stability quotientScrew a smart peg into the implant and record the values from a dedicated device | Diagnostic test | TISSUE LEVEL C, TISSUE LEVEL X |
Primary outcome
IMPLANT STABILITY QUOTIENT
Time frame: Monthly from T0 (implant insertion) to T12 (12 months after implant placement)
Values of risonance of implants taken by means of a dedicated device that translate the risonance of each implant into a number (0-99).
1 secondary outcome
Insertion torque
Time frame: At implant placement
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 28 Mar 2025.
- Derived from this study: PubMed 42927630Carosi P, Laureti A, Alrmali A, Pinto A, Wang HL, Lorenzi C. Design Matters? Evaluating Implant Macro-Geometry in Immediate Implants: A Randomized Clinical Trial With Six-Month Interim Analysis. Clin Exp Dent Res. 2026 Oct;12(5):e70490. doi: 10.1002/cre2.70490.
- 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.
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 stability quotient in people with Bone Healing and Implant Stability, run by University of Rome Tor Vergata 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 28 Mar 2025. 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?
Contact Paolo Carosi, PhD (+393277998699, paolo.carosi@alumni.uniroma2.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IMPLANT STABILITY QUOTIENT (time frame: Monthly from T0 (implant insertion) to T12 (12 months after implant placement)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06711744, which also lists 1 linked publication.
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 28 Mar 2025.