Conservative Surgery with Modified Widman Flap Vs Papilla Preservation Technique for the Treatment of Residual Pockets

NCT ID: NCT06661928

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-14
• Study Completion Date: 2030-12-01

Brief Summary

The primary aim of the study is to evaluate the efficacy of conservative surgery with or without papilla preservation technique 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

Papilla preservation flap

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

Group Type: EXPERIMENTAL

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

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 of less than 15% at re-evaluation.
• Full mouth bleeding score of less than 15% at re-evaluation.
• Sextant with residual probing pocket depth (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.

• 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

0116331543

Giacomo Baima

Role: CONTACT

giacomo.baima@unito.it

Other Identifiers

TurinPerioSurgery02

Identifier Type: -

Identifier Source: org_study_id