Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives

Last updated: October 23, 2023
Sponsor: University of Turin, Italy
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

Hyaluronic acid

Enamel matrix derivatives

Clinical Study ID

NCT06105112
HATurin
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To date, the quest for ideal biological inductors for periodontal regeneration is still ongoing, especially when facing non-containing defect anatomies. The primary aim of this study is to evaluate the clinical and radiographic performance of a bone graft combined with either enamel matrix derivatives or hyaluronic acid for periodontal regeneration of non-containing intrabony defects in terms of clinical attachment gain (primary outcome) and other secondary outcomes (probing pocket depth reduction, radiographic bone fill). Moreover, this study aims to compare early wound healing and patient-reported outcome measures.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Diagnosis of stage III-IV periodontitis.
  • Completed steps I-II periodontal therapy.
  • FMPS <15% at 3-month re-evaluation.
  • FMBS <15% at 3-month re-evaluation.
  • At least one site with intrabony defects and residual PPD ≥ 6 mm at re-evaluation,with a radiographic intrabony component ≥ 3 mm, and limited to no extension of thedefect on the lingual or 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) and it needs to be accessible by flap elevationonly on one side (either buccal or oral).
  • 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), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives).
  • Current smokers (self-reported, ≥ 10 cigarettes a day), users of chewing tobacco, anddrug/alcohol abusers.
  • Pregnant or nursing women.
  • Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Hyaluronic acid
Phase:
Study Start date:
October 01, 2023
Estimated Completion Date:
October 01, 2026

Connect with a study center

  • CIR Dental School

    Turin, 10126
    Italy

    Active - Recruiting

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