"Re-instrumentation vs Flap Surgery"

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05460988
• Other study ID #: 18876
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: May 11, 2024

Study information

• Verified date: October 2023
• Source: University of Florence
• Contact: Luigi Barbato, Dr.
• Phone: +39 3299457556
• Email: luigi.barbato[@]unifi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: May 11, 2024
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Pocket
• Periodontitis

Intervention

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).
• 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.

Locations

Country	Name	City	State
Italy	University of Florence	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD change	change in periodontal probing depth (in mm)	3 months after the procedure
Primary	PD change	change in periodontal probing depth (in mm)	6 months after the procedure
Primary	PD change	change in periodontal probing depth (in mm)	12 months after the procedure
Secondary	CAL change	change in clinical attachment level (in mm)	3 months after the procedure
Secondary	CAL change	change in clinical attachment level (in mm)	6 months after the procedure
Secondary	CAL change	change in clinical attachment level (in mm)	12 months after the procedure