NCT05460988

"Re-instrumentation vs Flap Surgery"

"Re-instrumentation vs Flap Surgery in Residual Pockets: a RCT on Clinical Efficacy"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Florence · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Periodontal Pocket
• Periodontitis

Interventions

Type	Name	Description
PROCEDURE	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).
PROCEDURE	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.

Timeline

• Start date: 2022-08-11
• Primary completion: 2023-05-11
• Completion: 2024-07-11
• First posted: 2022-07-15
• Last updated: 2025-04-10

Locations

1 site across 1 country: Italy