Status:
RECRUITING
Periodontal Regeneration With Hyaluronic Acid or Enamel Matrix Derivatives
Lead Sponsor:
University of Turin, Italy
Conditions:
Periodontitis
Eligibility:
All Genders
18+ years
Phase:
NA
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 th...
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 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.
Exclusion
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06105112
Start Date
October 1 2023
End Date
October 1 2026
Last Update
October 27 2023
Active Locations (1)
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1
CIR Dental School
Turin, Italy, 10126