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

NCT06663202 | Not Yet Recruiting

• 1 other identifier: TurinPerioSurgery
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Pocket closure

  Defined as probing pocket depth (PPD) of 3 mm or less or PPD of 4 mm with the absence of Bleeding on Probing in sites with PPD equal or more than 6 mm at baseline.

  5 years

Secondary Outcomes (5)

• Mean Probing Pocket Depth changes

  5 Years

• Mean Clinical Attachment Level changes

  5 years

• Mean recession changes

  5 years

• Tooth Retention

  5 years

• Number of instrumentation re-intervention

  5 years

Other Outcomes (2)

• Pain after surgery

  14 days

• Discomfort during surgery

  Immediately after surgery.

Study Arms (3)

Fiber Retention Osseous Resective Surgery

EXPERIMENTAL

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

Procedure: Fiber retention osseous resective surgery

Papilla preservation flap

ACTIVE COMPARATOR

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

Fiber retention osseous resective surgery 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.

Fiber Retention Osseous Resective Surgery

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 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.

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.
• Presence of furcation involvement ≥ II degree (Hamp 1975) at the affected teeth.
• Presence of deep infrabony defects (≥ 3 mm) at the involved sextant.

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

011 6331546; 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 29, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: October 31, 2024

Record last verified: 2024-10