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Osseous Resective Surgery Vs Conservative Surgery with or Without Papilla Preservation Technique
Sponsor: University of Turin, Italy
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.
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
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2024-11-15
Completion Date
2030-01-01
Last Updated
2024-10-31
Healthy Volunteers
No
Conditions
Interventions
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 connective tissue fibres attached to root cementum by means of periodontal probe. Flaps will be positioned at the level of the alveolar crest without tension.
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 mini-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Flaps will be positioned at the pre-surgical level without any tension. Monofilament non-resorbable 5-0 e-PTFE suturing material will be used. Suturing will be performed with external vertical mattress sutures to achieve primary intention closure.
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-curettes. Root surface debridement with ultrasonic debridement with periotip and mini-curettes. Flaps will be positioned at the level of the alveolar crest without tension. Monofilament nonresorbable 5 - 0 e/PTFE suturing material will be used. Suturing will be performed with single interrupted sutures.