Effectiveness of Intraseptal Anesthesia for Periodontal Surgical Procedures

Not Applicable

Recruiting

• Conditions: Periodontitis; Gingivitis and Periodontal Diseases

• Registration Number: NCT07212270
• Lead Sponsor: University of Belgrade

Brief 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) in periodontal flap surgery for periodontitis and in gingivectomy/gingivoplasty for the excision of hyperplastic gingival enlargements. The secondary aim is to compare clinical anesthetic parameters between ISA and conventional anesthesia techniques.

Detailed Description

In 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 sistem (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 were recorded by pinprick testing. Pain levels were recorded using a visual analogue scale (VAS) for the administration of anesthesia, during the surgical procedure and after the intervention.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-22
• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Primary Completion: 2025-12
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• age ≥18 years good systemic health
• gingivitis or periodontitis stage II and III
• at least 20 teeth present.

Exclusion Criteria

• allergy to 4%Ar+Ep
• pregnant or lactating females
• medication uptake and diseases affecting the periodontal tissues
• acute pain, swelling, and presence of gingival lesions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
anesthetic efficacy	5 min after injection	absence of pain for two pinprick tests in a row
width of the anesthetic field on buccal side	5 min after injection	maximal distance between the two painless needle's pricks on the buccal aspect of attached gingiva
width of the anesthetic field on oral side	5 min after injection	maximal distance between the two painless needle's pricks on the oral aspect of attached gingiva
VASa	immediately after anesthetic administration	intensity of pain measured on 100mm VAS scale
VASi	at the end of the treatment	intensity of pain measured on 100mm VAS scale
VASp	one day follow-up	intensity of pain measured on 100mm VAS scale
duration	form start to finish od intervention	duration of intervention

Trial Locations

Locations (1)

Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade; 🇷🇸 Belgrade, Serbia