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
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
ItalyActive - Recruiting

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