PeriodontitisNCT06105125
Autologous Micrografts From the Palatal Mucosa for Periodontal Regeneration
A study testing Rigenera + bone substitute and Bone substitute alone in people with Periodontitis, run by University of Turin, Italy at 1 site in Italy.
Trial summary
Some research studies have demonstrated that autologous micrografts made out of different oral tissues may enhance tissue regeneration. The primary aim of this study is to evaluate the clinical performance of a combined approach using an autologous micrograft derived from the palatal mucosa with an alloplastic… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Rigenera + bone substitute and Bone substitute alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteItaly
- Study dates
- 2 Nov 2023to 2 Nov 2025
- Phase
- Interventional
- 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
None listed.
Who cannot join
- Compromised general health which contraindicates the study procedures (ASA III-VI patients).
- Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulatory drugs (e.g., cyclosporine), and high-dose oral contraceptives.
- Current smokers (self-reported), users of chewing tobacco, and drug/alcohol abusers.
- Pregnant or nursing women.
- Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
- Very large and wide defects that required the use of membrane.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
CIR Dental School
Turin, 10126
Mario Aimetti, Prof., +39116331541, mario.aimetti@unito.it
About this study
Official title: Periodontal Regeneration in Non-contained Intrabony Defects Using Autologous Micrografts From the Palatal Mucosa: a Randomized Controlled Clinical Trial
Some research studies have demonstrated that autologous micrografts made out of different oral tissues may enhance tissue regeneration. The primary aim of this study is to evaluate the clinical performance of a combined approach using an autologous micrograft derived from the palatal mucosa with an alloplastic scaffold for periodontal regeneration of intrabony defects in terms of clinical attachment level gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill) compared to a scaffold alone. Moreover, this study aims to compare early wound healing and patient-reported outcome measures between the two groups.
- Conditions
- Periodontitis
- Being tested
- Rigenera + bone substitute, Bone substitute alone
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigenera + bone substituteDevice
Minimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. A small punch of connective tissue will be harvested from the palate in the premolar region. Then the graft will be mechanically dissociated using the Rigenera Machine System rotating speed to 80 rpm, in 1.0 ml sterile physiologic solution. After dissociation, the cellular suspension will be passed through a disposable grid with 100 hexagonal blades filtering cells and components of extracellular matrix with a cut-off of 50 um in an average time of 90 s. Finally, part of the suspension containing AMGs will be seeded on the scaffold material and subsequently compacted within the defect. Flaps will be positioned at the pre-surgical level or slightly coronal without any tension.
Bone substitute aloneDevice
Minimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. The defect will be filled with the same bone substitute employed in the test group. Finally, flaps will be positioned at the pre-surgical level or slightly coronal without any tension.
| Study group | Role | What they receive |
|---|---|---|
| Autologous micrograft from the palate | Experimental | Modified papilla preservation technique with a combined approach using a bone substitute soaked with autologous micrografts from the palate. Receives: Device: Rigenera + bone substitute |
| Control group | Active comparator | Modified papilla preservation technique with a combined approach using a bone substitute. Receives: Device: Bone substitute alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment level change
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Measured: 12 months
Secondary outcomes (3)
Probing pocket depth change
Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Measured: 12 months
Radiographic bone level change
Periapical standardized radiographs will be taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA)
Measured: 12 months
Patient reported outcome measures
Pain will be self-recorded by the patient using a visual analog scale (from 0 to 10)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start2 Nov 2023
- Primary completion2 Nov 2024 (estimated)
- Study completion2 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Aimetti, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105125
- Sponsor's protocol ID
- Rigenera_Turin
- Status last verified
- Nov 2023
- First submitted
- 17 Oct 2023
- Last updated
- 28 Nov 2023
- 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 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Regeneration in Non-contained Intrabony Defects Using Autologous Micrografts From the Palatal Mucosa: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06105125
- Acronym / sponsor ID
- Rigenera_Turin
- Conditions
- Periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 2 Nov 2024 (estimated)
- Study completion
- 2 Nov 2025 (estimated)
- First posted
- 27 Oct 2023 (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.
Some research studies have demonstrated that autologous micrografts made out of different oral tissues may enhance tissue regeneration. The primary aim of this study is to evaluate the clinical performance of a combined approach using an autologous micrograft derived from the palatal mucosa with an alloplastic scaffold for periodontal regeneration of intrabony defects in terms of clinical attachment level gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill) compared to a scaffold alone. Moreover, this study aims to compare early wound healing and patient-reported outcome measures between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous micrograft from the palate | Experimental | Device: Rigenera + bone substituteModified papilla preservation technique with a combined approach using a bone substitute soaked with autologous micrografts from the palate. |
| Control group | Active comparator | Device: Bone substitute aloneModified papilla preservation technique with a combined approach using a bone substitute. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Compromised general health which contraindicates the study procedures (ASA III-VI patients).
- Systemic diseases/medications which could influence the outcome of the therapy (e.g. uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepileptic drugs (phenytoin and sodium valproate), certain calcium channel-blocking drugs (e.g., nifedipine, verapamil, diltiazem, amlodipine, felodipine), immunoregulatory drugs (e.g., cyclosporine), and high-dose oral contraceptives.
- Current smokers (self-reported), users of chewing tobacco, and drug/alcohol abusers.
- Pregnant or nursing women.
- Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
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 |
|---|---|---|
| Rigenera + bone substituteMinimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. A small punch of connective tissue will be harvested from the palate in the premolar region. Then the graft will be mechanically dissociated using the Rigenera Machine System rotating speed to 80 rpm, in 1.0 ml sterile physiologic solution. After dissociation, the cellular suspension will be passed through a disposable grid with 100 hexagonal blades filtering cells and components of extracellular matrix with a cut-off of 50 um in an average time of 90 s. Finally, part of the suspension containing AMGs will be seeded on the scaffold material and subsequently compacted within the defect. Flaps will be positioned at the pre-surgical level or slightly coronal without any tension. | Device | Autologous micrograft from the palate |
| Bone substitute aloneMinimally invasive flap elevation and debridement of the intrabony defect with micro-curettes. The defect will be filled with the same bone substitute employed in the test group. Finally, flaps will be positioned at the pre-surgical level or slightly coronal without any tension. | Device | Control group |
Primary outcome
Clinical attachment level change
Time frame: 12 months
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
3 secondary outcomes
Probing pocket depth change
Time frame: 12 months
Radiographic bone level change
Time frame: 12 months
Patient reported outcome measures
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rigenera + bone substitute and Bone substitute alone in people with Periodontitis, run by University of Turin, Italy 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 0 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Aimetti, PA (011 6331546 ext. 0039, mario.aimetti@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical attachment level change (time frame: 12 months). 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 28 Nov 2023.