"Re-instrumentation vs Flap Surgery"

NCT05460988 | Completed DMC

• 1 other identifier: 18876
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontal Pocket; Periodontitis

Keywords

non-surgical periodontal therapy; re-instrumentation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• CAL change

  3 months after the procedure

• CAL change

  6 months after the procedure

• CAL change

  12 months after the procedure

Study Arms (2)

Non surgical re-instrumentation

EXPERIMENTAL

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

Flap surgery

ACTIVE COMPARATOR

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

Interventions

Flap surgery PROCEDURE

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).

Flap surgery

Non surgical re-instrumentation PROCEDURE

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.

Non surgical re-instrumentation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

University of Florence

Florence, Florence, 50134, Italy

Location

Related Publications (1)

• Barbato L, Noce D, Di Martino M, Castelluzzo W, Spoleti F, Rupe C, Nieri M, Cairo F. Non-surgical retreatment versus papillary preservation flap surgery for residual pockets: A randomized controlled trial with clinical and patient-reported outcomes. J Clin Periodontol. 2024 Oct;51(10):1277-1288. doi: 10.1111/jcpe.14047. Epub 2024 Jul 16.

  PMID: 39011585 DERIVED

MeSH Terms

Conditions

Periodontal Pocket; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor and principal investigator

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 15, 2022
• Study Start: August 11, 2022
• Primary Completion: May 11, 2023
• Study Completion: July 11, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

IT (1)