Autologous Micrografts From the Palatal Mucosa for Periodontal Regeneration

NCT06105125 | Unknown

• 1 other identifier: Rigenera_Turin
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Secondary Outcomes (3)

• Probing pocket depth change

  12 months

• Radiographic bone level change

  12 months

• Patient reported outcome measures

  2 weeks

Study Arms (2)

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.

Device: Rigenera + bone substitute

Control group

ACTIVE COMPARATOR

Modified papilla preservation technique with a combined approach using a bone substitute.

Device: Bone substitute alone

Interventions

Rigenera + bone substitute DEVICE

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.

Autologous micrograft from the palate

Bone substitute alone DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Affected from stage III-IV periodontitis.
• Completed non-surgical periodontal therapy.
• FMPS \<15% at 3-month re-evaluation.
• FMBS \<15% at 3-month re-evaluation.
• At least one site with an interproximal intrabony defects and residual PPD ≥ 6 mm at re-evaluation, with a radiographic intrabony component ≥ 3 mm, extending to the lingual/palatal side as assessed by preoperative bone sounding.
• Intrasurgically, the defect has to present a non-supporting anatomy (1-2 residual walls in its most coronal portion), requiring flap elevation on both buccal and oral side for its accessibility.
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

CIR Dental School

Turin, 10126, Italy

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Mario Aimetti, PA

CONTACT

011 6331546; mario.aimetti@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 27, 2023
• Study Start: November 2, 2023
• Primary Completion: November 2, 2024
• Study Completion: November 2, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

IT (1)