Osseous Resective Surgery Vs Conservative Surgery with or Without Papilla Preservation Technique (FibReORS vs AF)

University of Turin

Status: Not yet enrolling

Conditions: Periodontitis

Treatments: Procedure: Widman flap procedure; Procedure: Papilla preservation flap; Procedure: Fiber retention osseous resective surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06663202

TurinPerioSurgery

Details and patient eligibility

About

The primary aim of the study is to evaluate the efficacy of either fibre retention osseous resective surgery (FibReORS) or conservative surgery with or without PPT 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.

Enrollment: 120 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of stage III/IV periodontitis.
• Completed steps I-II periodontal therapy at least 6 weeks before.
• Full Mouth Plaque Score less than 15% at re-evaluation.
• Full Mouth Bleeding Score less than 15% at re-evaluation.
• Posterior sextant with residual PPD ≥ 6 mm at ≥ 2 natural teeth (third molars excluded).
• 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).
• Pregnant or nursing women.
• Presence of tooth mobility ≥ class 2.
• Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
• Presence of deep infrabony defects (≥ 3 mm) at the involved sextant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Fiber Retention Osseous Resective Surgery

Experimental group

Description:

Paramarginal incisions both on buccal and lingual/palatal sides with bone remodelling preserving the supracrestal fibers

Treatment:

Procedure: Fiber retention osseous resective surgery

Papilla preservation flap

Active Comparator group

Description:

Access flap for open flap debridement using intrasulcular incisions and papilla preservation approaches to preserve the entire interdental tissues

Treatment:

Procedure: Papilla preservation flap

Conventional surgery

Active Comparator group

Description:

Access flap for open flap debridement using a conventional modified Widman flap procedure

Treatment:

Procedure: Widman flap procedure