Autologous Micrografts From the Palatal Mucosa for Periodontal Regeneration

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.

Study Overview

• Status: Recruiting
• Conditions: Periodontitis
• Intervention / Treatment: Device: Rigenera + bone substitute; Device: Bone substitute alone

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Aimetti, PA; Phone Number: 0039 011 6331546; Email: mario.aimetti@unito.it

Study Locations

• Italy
  • Turin, Italy, 10126
    • Recruiting
    • CIR Dental School
    • Contact: Mario Aimetti, Prof.; Phone Number: +39116331541; Email: mario.aimetti@unito.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Patients selected for the study should fulfil the following inclusion criteria:

• 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.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Autologous micrograft from the palate; Modified papilla preservation technique with a combined approach using a bone substitute soaked with autologous micrografts from the palate.	Device: Rigenera + bone substitute; 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.
Active Comparator: Control group; Modified papilla preservation technique with a combined approach using a bone substitute.	Device: Bone substitute alone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	12 months
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)	12 months
Patient reported outcome measures	Pain will be self-recorded by the patient using a visual analog scale (from 0 to 10)	2 weeks

Collaborators and Investigators

• Sponsor: University of Turin, Italy

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Estimated): November 2, 2024
• Study Completion (Estimated): November 2, 2025

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 23, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: Rigenera_Turin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No