NCT06105112 Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives
| NCT ID | NCT06105112 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Turin, Italy |
| Condition | Periodontitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-10-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 the defect on the lingual or 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) and it needs to be accessible by flap elevation only on one side (either buccal or oral). * 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), immunoregulating drugs (e.g., ciclosporine), and high-dose oral contraceptives). * Current smokers (self-reported, ≥ 10 cigarettes a day), users of chewing tobacco, and drug/alcohol abusers. * Pregnant or nursing women. * Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06105112 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Periodontitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06105112 currently recruiting?
Yes, NCT06105112 is actively recruiting participants. Contact the research team at mario.aimetti@unito.it for enrollment information.
Where is the NCT06105112 trial being conducted?
This trial is being conducted at Turin, Italy.
Who is sponsoring the NCT06105112 clinical trial?
NCT06105112 is sponsored by University of Turin, Italy. The trial plans to enroll 60 participants.