NCT07212270

Effectiveness of Intraseptal Anesthesia for Periodontal Surgical Procedures

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Belgrade · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of this study is to evaluate the efficacy of intraseptal anesthesia using 0.3 mL of 4% articaine with 1:100,000 epinephrine (4% Ar+Ep) for periodontal flap surgery in patients with periodontitis and for gingivectomy/ gingivoplasty for the excision of hyperplastic gingival enlargements. The secondary aim is to compare clinical anesthetic parameters between the ISA and conventional anesthesia techniques.

Detailed description

In the test groups every patient is going to receive injections of 0.3 mL of 4% articaine with 1: 100,000 epinephrine (ORABLOC ® , 40 mg/ml Articaine + 0.01 mg/ml Epinephrine, PIERREL S.P.A, Capua, Italy), with a computer controlled anesthesia delivery system (Anaeject®, Septodont, Sallanches, France). In the control groups all surgical procedures is going to be performed under infiltration anesthesia, as commonly used in periodontal surgery. The success rate and the anesthetic field widths is going to be recorded by pinprick testing. The pain levels will be recorded using the Visual Analogue Scale (VAS) for the administration of anesthesia, during the surgical procedure and after the intervention.

Conditions

• Periodontitis
• Gingivitis and Periodontal Diseases

Interventions

Type	Name	Description
PROCEDURE	periodontal flap surgery	Open flap debridement with intra-sulcular incisions or flaps with para-marginal incisions were performed by lifting the mucoperiosteal flap and debriding the periodontal defect under visual control.
PROCEDURE	gingivectomy and gingivoplasty	surgical methods for the excision of hyperplastically enlarged gingiva.

Timeline

• Start date: 2025-09-22
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2025-10-08
• Last updated: 2026-02-11

Locations

1 site across 1 country: Serbia