"Re-instrumentation vs Flap Surgery"

University of Florence (UNIFI)

Status: Completed

Conditions: Periodontitis; Periodontal Pocket

Treatments: Procedure: Non surgical re-instrumentation; Procedure: Flap surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05460988

18876

Details and patient eligibility

About

There are no studies comparing reinstrumentation and flap surgery for the treatment of residual periodontal pockets.

The aim of this RCT is to compare the re-instrumentation vs the flap surgery in terms of PD reduction, CAL gain, gingival recession, need of an additional surgery and pocket closure. Moreover, PROMs will be evaluated

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18aa
• Patients with periodontal disease
• Less than 20 cigarettes/day
• No systemic antibiotic therapy in the last 3 months
• At least one interdental site showing PD≥5mm after the non surgical periodontal initial therapy. Infrabony component of the defect ≤3mm at x-ray
• Full-mouth plaque score and full-mouth bleeding score <15% at baseline (re-evaluation) measured at six sites per tooth
• No previous periodontal surgery at the experimental tooth

Exclusion criteria

• Connective tissue diseases
• Diabetes
• Pregnancy or lactating
• Furcation involvement
• Crowned tooth
• Severe tooth mobility (class III)
• Radiographical horizontal bone resorption exceeding the 50% of the root

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups

Non surgical re-instrumentation

Experimental group

Description:

The sites showing remaining pockets (PD\>4mm), in the sextants allocated to re-instrumentation group, will be treated with subgingival debridement. The subgingival debridement will be performed after the administration of local oral anaesthesia (Articaine 1:100000) using a periodontal tip on ultrasonic instrument (EMS) and Gracey's curettes.

Treatment:

Procedure: Non surgical re-instrumentation

Flap surgery

Active Comparator group

Description:

All the sites showing a residual pocket in a sextant allocated to surgery group will receive flap surgery. After the administration of oral local anaesthesia (Articaine 1:100000) an intrasulcular flap will be raised. In order to preserve interdental tissue the flaps will be designed accordingly the principles of papillary preservation flap. Toot root will be carefully debrided using both ultrasonic instruments and Grecey's curettes. Bone recontouring and ostectomy/osteoplasty will be avoided. Single simple sutures will be used to close the flap (Vicryl 5-0).

Treatment:

Procedure: Flap surgery