"Re-instrumentation vs Flap Surgery"

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

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 Overview

• Status: Completed
• Conditions: Periodontitis; Periodontal Pocket
• Intervention / Treatment: Procedure: Non surgical re-instrumentation; Procedure: Flap surgery

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Florence, Italy, 50134
    • University of Florence

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PD change	change in periodontal probing depth (in mm)	3 months after the procedure
PD change	change in periodontal probing depth (in mm)	6 months after the procedure
PD change	change in periodontal probing depth (in mm)	12 months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAL change	change in clinical attachment level (in mm)	3 months after the procedure
CAL change	change in clinical attachment level (in mm)	6 months after the procedure
CAL change	change in clinical attachment level (in mm)	12 months after the procedure

Collaborators and Investigators

• Sponsor: University of Florence

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2022
• Primary Completion (Actual): May 11, 2023
• Study Completion (Actual): July 11, 2024

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: July 12, 2022
• First Posted (Actual): July 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 10, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: non-surgical periodontal therapy; re-instrumentation
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontitis; Periodontal Pocket
• Other Study ID Numbers: 18876

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No