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NCT Number: NCT06663202

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

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Pocket closure

    Time frame: 5 years

    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.

Secondary outcomes

  1. Mean Probing Pocket Depth changes

    Time frame: 5 Years

    Defined as the mean changes in Probing pocket depth (distance in mm from the gingival margin to the bottom of the probable sulcus) at the involved sextant with respect to baseline.

  2. Mean Clinical Attachment Level changes

    Time frame: 5 years

    Defined as the mean changes in Clinical Attachment Level (distance in mm from the Cemento Enamel Junction to the bottom of the probable sulcus) at the involved sextant with respect to baseline.

  3. Mean recession changes

    Time frame: 5 years

    Defined as the changes in recession (distance in mm from cemento enamel junction to the gingival margin).

  4. Tooth Retention

    Time frame: 5 years

    Number of teeth in the treated sextant present at the last follow-up evaluation.

  5. Number of instrumentation re-intervention

    Time frame: 5 years

    Number of re-instrumentation interventions during supportive periodontal therapy performed at sites with incomplete outcome.

Other outcomes

  1. Pain after surgery

    Time frame: 14 days

    The patient will self report pain on a 10 cm visual analog scale [0-100].

  2. Discomfort during surgery

    Time frame: Immediately after surgery.

    Self reported on a 10 cm visual analog scale [0-100].

Study contacts

Contact information is provided by the study sponsor or research team.

Giacomo Baima

CONTACT

[email protected]

Mario Aimetti, Prof.

CONTACT

[email protected]

011 6331546

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study 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

Acronym: FibReORS vs AF

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Oct 29, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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