Implant TherapyPhase 4NCT06862505
Histological Analysis of Peri-implant Soft Tissue
A Phase 4 study testing Biopsy in people with Implant Therapy and Biological Width, run by Università degli Studi di Sassari at 1 site in Italy.
Trial summary
The aim of this study is to evaluate the histologically analysis in humans and the orientation of collagen fibers around screw-less, morse taper implant-abutment connection. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implant Therapy, Biological Width
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2024to 3 Feb 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older, affected by partial edentulism of posterior elements need for at least two single implant rehabilitations
- able to understand a sign an informed consent
Who cannot join
- Peapole having a systemic or local contraindications for implant placement;
- Untreated periodontal disease;
- smokers;
- osteoporosis;
- uncontrolled diabetes;
- refusal to implant rehabilitation;
- refusal to biopsy collection;
- systemic pathologies that could compromise the healing of peri-implant tissues.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histological Analysis of Collagen Fibers Around Screw-less, Morse Taper Implant-abutment Connection 8 and 16 Weeks After Implant Uncovering: a Split-mouth Randomized Controlled Trial
The aim of this study is to evaluate the histologically analysis in humans and the orientation of collagen fibers around screw-less, morse taper implant-abutment connection.
- Conditions
- Implant Therapy, Biological Width
- Being tested
- Biopsy
- Keywords
- Dental implants, Biological width, Istological analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Biopsy of soft tissue were taken randomly at 8 or 16 weeks to compare soft tissue
| Study group | Role | What they receive |
|---|---|---|
| Biopsy at 8 weeks | Experimental | Not described Receives: Procedure: Biopsy |
| Biopsy at 16 weeks | Active comparator | Not described Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological analisys
Histological analysis of peri-implant gengivaat 8 and 16 weeks to assess collagen fibre orientation
Measured: 8 and 16 weeks
Secondary outcomes (1)
Histomorphometry
Quantitative measure of soft tissues
Measured: 8 and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start15 Feb 2024
- Primary completion1 Sep 2024
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Implant TherapyStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Tallarico, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862505
- Sponsor's protocol ID
- 15-16/12/24
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 6 Mar 2025
- 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Analysis of Collagen Fibers Around Screw-less, Morse Taper Implant-abutment Connection 8 and 16 Weeks After Implant Uncovering: a Split-mouth Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06862505
- Acronym / sponsor ID
- 15-16/12/24
- Conditions
- Implant Therapy, Biological Width
- Keywords
- Dental implants, Biological width, Istological analysis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 6 Mar 2025 (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 study is to evaluate the histologically analysis in humans and the orientation of collagen fibers around screw-less, morse taper implant-abutment connection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biopsy at 8 weeks | Experimental | Procedure: Biopsy |
| Biopsy at 16 weeks | Active comparator | Procedure: Biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older, affected by partial edentulism of posterior elements need for at least two single implant rehabilitations
- able to understand a sign an informed consent
Key exclusion criteria (8 listed)
- Peapole having a systemic or local contraindications for implant placement;
- Untreated periodontal disease;
- smokers;
- osteoporosis;
- uncontrolled diabetes;
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 |
|---|---|---|
| BiopsyBiopsy of soft tissue were taken randomly at 8 or 16 weeks to compare soft tissue | Procedure or surgery | Biopsy at 16 weeks, Biopsy at 8 weeks |
Primary outcome
Histological analisys
Time frame: 8 and 16 weeks
Histological analysis of peri-implant gengivaat 8 and 16 weeks to assess collagen fibre orientation
1 secondary outcome
Histomorphometry
Time frame: 8 and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Implant Therapy
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
Chronic Pain, Intractable Pain
Recruiting
BioPoly® Partial Resurfacing Knee Implant IDE
Knee Pain Chronic, Knee Osteoarthritis
RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Not yet recruitingObservational study
Standardized Management of Esophageal Fistula in Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC), Esophageal Fistula
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.
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 Phase 4 study testing Biopsy in people with Implant Therapy and Biological Width, 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 6 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Histological analisys (time frame: 8 and 16 weeks). 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 6 Mar 2025.