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

ConditionPeriodontitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Turin, Italy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fiber retention osseous resective surgery

    Procedure/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.

  • Papilla preservation flap

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Fiber Retention Osseous Resective SurgeryExperimental treatment 1 intervention
Group B: Papilla preservation flapActive comparator 1 intervention
Group C: Conventional surgeryActive comparator 1 intervention

Trial outcomes

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.

Time frame
5 years

Secondary outcomes

1

Mean Probing Pocket Depth changes

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.

Time frame
5 Years
2

Mean Clinical Attachment Level changes

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.

Time frame
5 years
3

Mean recession changes

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

Time frame
5 years
4

Tooth Retention

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

Time frame
5 years

Other outcomes

1

Pain after surgery

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

Time frame
14 days
2

Discomfort during surgery

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

Time frame
Immediately after surgery.

Locations

This trial has no locations.

Sponsors and contacts

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