Osseous Resective Surgery Vs Conservative Surgery with or Without Papilla Preservation Technique
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fiber retention osseous resective surgery, Papilla preservation flap, Widman flap procedure.
- Who it may be relevant to
- Registry conditions: Periodontitis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Procedure Fiber retention osseous resective surgery
At the buccal and lingual sides, paramarginal or intrasulcular incisions will be made based on probing pocket depth values and the width of keratinised tissues. Thinned palatal flap technique will be performed on the palatal side. Bone remodelling will be carefully made using manual or rotary instruments in order to reshape positive attached fibres/bony architecture utilising the FibReORS technique, great attention will be made to distinguish between inflammatory granulation tissue and connecti - Procedure Papilla preservation flap
Surgical access will be obtained using modified papilla preservation techniques and when interproximal space is narrow (less than 3mm in width) incision will be made using the simplified papilla preservation flap. Both flaps buccal and lingual/palatal will be elevated in any case to allow root surface cleaning and defects debridement under direct vision. Minimally invasive flap elevation preventing to damage inter proximal tissues with the preservation of the papilla. Defects debridement with mi - Procedure Widman flap procedure
Surgical access will be obtained using the modified Widman flap technique. Intrasulcular incision will be done on both buccal and lingual/palatal sides without attempting to preserve the interdental tissues and interdental tissues will be removed. Both flaps buccal and lingual/palatal will be elevated at full thickness in any case to allow root surface cleaning and defects debridement under direct vision, a vertical releasing incision could be made when needed. Defects debridement with mini-cur
Primary outcome measures
- Pocket closure [Time frame: 5 years]
Secondary outcome measures (5)
- Mean Probing Pocket Depth changes [Time frame: 5 Years]
- Mean Clinical Attachment Level changes [Time frame: 5 years]
- Mean recession changes [Time frame: 5 years]
- Tooth Retention [Time frame: 5 years]
- Number of instrumentation re-intervention [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06663202 · TurinPerioSurgery