"Re-instrumentation vs Flap Surgery"

Not Applicable

Completed

• Conditions: Periodontitis; Periodontal Pocket
• Interventions: Procedure: Flap surgery; Procedure: Non surgical re-instrumentation

• Registration Number: NCT05460988
• Lead Sponsor: University of Florence

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-12
• Study First Posted: 2022-07-15
• Study Start: 2022-08-11
• Primary Completion: 2023-05-11
• Study Completion: 2024-07-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flap surgery	Flap surgery	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-instrumentation	Non surgical re-instrumentation	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.

Primary Outcome Measures

Name	Time	Method
PD change	12 months after the procedure	change in periodontal probing depth (in mm)

Secondary Outcome Measures

Name	Time	Method
CAL change	12 months after the procedure	change in clinical attachment level (in mm)

Trial Locations

Locations (1)

University of Florence; 🇮🇹 Florence, Italy