Effectiveness of Intraseptal Anesthesia for Periodontal Surgical Procedures

University of Belgrade

Status: Enrolling

Conditions: Periodontitis; Gingivitis and Periodontal Diseases

Treatments: Procedure: gingivectomy and gingivoplasty; Procedure: periodontal flap surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT07212270

UBelgrade 36/8 (2)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 4 patient groups

GG test

Experimental group

Description:

patient subjected to gingivectomy and gingiveplasty interventions and anesthesia of choice is intraseptal anesthesia

Treatment:

Procedure: gingivectomy and gingivoplasty

GG control

Active Comparator group

Description:

patient subjected to gingivectomy and gingiveplasty interventions under local infiltration anesthesia

Treatment:

Procedure: gingivectomy and gingivoplasty

PF test

Experimental group

Description:

Patients undergoing periodontal flap surgery under intraseptal anesthesia

Treatment:

Procedure: periodontal flap surgery

PF control

Active Comparator group

Description:

Patients undergoing periodontal flap surgery under local infiltration anesthesia

Treatment:

Procedure: periodontal flap surgery