About this trial
The primary aim of the study is to evaluate the efficacy of conservative surgery with or without papilla preservation technique in the treatment of deep residual pockets ≥ 6 mm in stage III-IV periodontitis patients after cause related therapy (step II) in terms of endpoints of therapy and other secondary outcomes at different time intervals (1, 3 and 5 years). Moreover, the study aims to evaluate the stability of the results obtained for the different surgical approaches over a 5 years follow-up period.
Eligibility criteria
Qualifiers
Diagnosis of stage III/IV periodontitis.
Completed steps I-II periodontal therapy at least 6 weeks before.
Full mouth plaque score of less than 15% at re-evaluation.
Full mouth bleeding score of less than 15% at re-evaluation.
Disqualifiers
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).
Pregnant or nursing women.
Presence of tooth mobility ≥ class 2.
Trial design
Treatments tested in this trial
- Papilla preservation flap
- Widman flap procedure