"Re-instrumentation vs Flap Surgery"

University of Florence46 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Periodontal Pocket Periodontitis

Interventions

Flap surgeryPROCEDURE

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).

Non surgical re-instrumentationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Florence

Florence, Florence, Italy

Outcomes

Primary Outcomes

PD change

change in periodontal probing depth (in mm)

Time frame: 3 months after the procedure

PD change

change in periodontal probing depth (in mm)

Time frame: 6 months after the procedure

PD change

change in periodontal probing depth (in mm)

Time frame: 12 months after the procedure

Secondary Outcomes

CAL change

change in clinical attachment level (in mm)

Time frame: 3 months after the procedure

CAL change

change in clinical attachment level (in mm)

Time frame: 6 months after the procedure

CAL change

change in clinical attachment level (in mm)

Time frame: 12 months after the procedure

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.