Autologous Micrografts From the Palatal Mucosa for Periodontal Regeneration

Sponsor

University of Turin, Italy (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06105125

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis	Device: Rigenera + bone substitute Device: Bone substitute alone	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 2, 2023

Anticipated Primary Completion Date :

Nov 2, 2024

Anticipated Study Completion Date :

Nov 2, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Clinical attachment level change [12 months]
Clinical attachment level will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)

Secondary Outcome Measures

Probing pocket depth change [12 months]
Probing depth will be assessed on the experimental teeth using periodontal probe (PCP 15/11.5, Hu-Friedy, Chicago, IL, USA)
Radiographic bone level change [12 months]
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)
Patient reported outcome measures [2 weeks]
Pain will be self-recorded by the patient using a visual analog scale (from 0 to 10)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Turin, Italy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mario Aimetti, Associate Professor, University of Turin, Italy

ClinicalTrials.gov Identifier:

NCT06105125

Other Study ID Numbers:

Rigenera_Turin

First Posted:

Oct 27, 2023

Last Update Posted:

Oct 27, 2023

Last Verified:

Oct 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Periodontitis

Study Results

No Results Posted as of Oct 27, 2023