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

NCT06661928 | Not Yet Recruiting

• 1 other identifier: TurinPerioSurgery02
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Pocket closure

  Defined as Probing pocket depth of 3 mm or less or Probing pocket depth of 4 mm with the absence of Bleeding on Probing in sites with Probing pocket depth of 6 mm or more at baseline.

  5 years

Secondary Outcomes (5)

• Tooth Retention

  5 years

• Number of instrumentation re-intervention

  5 years

• Mean Probing Pocket Depth changes

  5 years

• Mean Clinical Attachment Level changes

  5 years

• Mean recession changes

  5 years

Other Outcomes (1)

• Discomfort during surgery

  Immediately after surgery.

Study Arms (2)

Papilla preservation flap

EXPERIMENTAL

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

Procedure: Papilla preservation flap

Conventional surgery

ACTIVE COMPARATOR

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

Procedure: Widman flap procedure

Interventions

Papilla preservation flap 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.

Papilla preservation flap

Widman flap procedure 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.

Conventional surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Turin, Italy: lead

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Mario Aimetti, Prof.

CONTACT

0116331543; mario.aimetti@unito.it

Giacomo Baima

CONTACT

giacomo.baima@unito.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 28, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: October 28, 2024

Record last verified: 2024-10