Autologous Micrografts From the Palatal Mucosa for Periodontal Regeneration

Periodontitis Clinical Trial

Official title:

Periodontal Regeneration in Non-contained Intrabony Defects Using Autologous Micrografts From the Palatal Mucosa: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105125
• Other study ID #: Rigenera_Turin
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: November 2, 2025

Study information

• Verified date: November 2023
• Source: University of Turin, Italy
• Contact: Mario Aimetti, PA
• Phone: 011 6331546
• Email: mario.aimetti[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: November 2, 2025
• Est. primary completion date: November 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	CIR Dental School	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patient reported outcome measures	Pain will be self-recorded by the patient using a visual analog scale (from 0 to 10)	2 weeks