Osseous Resective Surgery Vs Conservative Surgery with or Without Papilla Preservation Technique

NCT ID: NCT06663202

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2030-01-01

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fiber Retention Osseous Resective Surgery

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

Group Type: EXPERIMENTAL

Fiber retention osseous resective surgery

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

Papilla preservation flap

Intervention Type: PROCEDURE

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.

Conventional surgery

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

Group Type: ACTIVE_COMPARATOR

Widman flap procedure

Intervention Type: 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.

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.

Intervention Type: 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 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.

Intervention Type: 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-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.

Intervention Type: PROCEDURE

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: lead

Responsible Party

Mario Aimetti

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Mario Aimetti, Prof.

Role: CONTACT

mario.aimetti@unito.it

011 6331546

Giacomo Baima

Role: CONTACT

giacomo.baima@unito.it

Other Identifiers

TurinPerioSurgery

Identifier Type: -

Identifier Source: org_study_id