Autologous Micrografts From the Palatal Mucosa for Periodontal Regeneration

Last updated: November 27, 2023
Sponsor: University of Turin, Italy
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

Rigenera + bone substitute

Bone substitute alone

Clinical Study ID

NCT06105125
Rigenera_Turin
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 atre-evaluation, with a radiographic intrabony component ≥ 3 mm, extending to thelingual/palatal side as assessed by preoperative bone sounding.
  • Intrasurgically, the defect has to present a non-supporting anatomy (1-2 residualwalls in its most coronal portion), requiring flap elevation on both buccal and oralside for its accessibility.
  • Signed informed consent.

Exclusion

Exclusion criteria:

  • Compromised general health which contraindicates the study procedures (ASA III-VIpatients).
  • Systemic diseases/medications which could influence the outcome of the therapy (e.g.uncontrolled diabetes mellitus, non-plaque-induced gingival diseases, antiepilepticdrugs (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 Design

Total Participants: 38
Treatment Group(s): 2
Primary Treatment: Rigenera + bone substitute
Phase:
Study Start date:
November 02, 2023
Estimated Completion Date:
November 02, 2025

Connect with a study center

  • CIR Dental School

    Turin, 10126
    Italy

    Active - Recruiting

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