Fibre-Retention Osseous Resective Surgery (FibReORS) Vs Conservative Surgery with or Without Papilla Preservation Technique for the Treatment of Residual Pockets: a 5-year Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- Pocket closure
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
- •Presence of deep infrabony defects (≥ 3 mm) at the involved sextant.
Arms & Interventions
Fiber Retention Osseous Resective Surgery
Paramarginal incisions both on buccal and lingual/palatal sides with bone remodelling preserving the supracrestal fibers
Intervention: Fiber retention osseous resective surgery (Procedure)
Papilla preservation flap
Access flap for open flap debridement using intrasulcular incisions and papilla preservation approaches to preserve the entire interdental tissues
Intervention: Papilla preservation flap (Procedure)
Conventional surgery
Access flap for open flap debridement using a conventional modified Widman flap procedure
Intervention: Widman flap procedure (Procedure)
Outcomes
Primary Outcomes
Pocket closure
Time Frame: 5 years
Defined as probing pocket depth (PPD) of 3 mm or less or PPD of 4 mm with the absence of Bleeding on Probing in sites with PPD equal or more than 6 mm at baseline.
Secondary Outcomes
- Mean Probing Pocket Depth changes(5 Years)
- Mean Clinical Attachment Level changes(5 years)
- Mean recession changes(5 years)
- Tooth Retention(5 years)
- Number of instrumentation re-intervention(5 years)
Investigators
Mario Aimetti
Associate Professor
University of Turin, Italy