Efficacy of Intraseptal Anesthesia of 4% Articaine With Epinephrine Achieved by Computer-controlled Delivery System (EISAAECCLAD)

University of Belgrade

Status and phase: Active, not recruiting; Phase 4

Conditions: Periodontitis; Anesthesia, Local

Treatments: Procedure: scaling and root planing

Study type: Observational

Funder types: Other

Identifiers

NCT04392804

UBelgrade 36/8

Details and patient eligibility

About

The aims of our study were to evaluate the clinical anesthetic parameters of the intraseptal anesthesia (ISA), achieved by computer-controlled local anesthetic delivery system CCLADS, for scaling and root planing, as a primary outcome of the study. In addition, as secondary outcome of the study the impact of destruction of the periodontal supporting tissues on clinical anesthetic parameters of the ISA achieved by 4% articaine with 1:100,000 epinephrine, using CCLAD system.

Full description

After including the patients into the study, patient needs to sign a written consent. After that, the next appointment will be scheduled. On the next appointment, each patient included in this study will undergo ultrasound cleaning and receive guidance for adequate everyday oral hygiene. The next appointment, after 10 days will be scaling and root planing for selected periodontal pockets. Because it is painful treatment, anesthesia is needed to be administrated. Patients will be split into three groups by picking cards, for receiving different doses of 4% articaine with 1:100,000 epinephrine ORABLOC® (40 mg/ml Articaine + 0.01 mg/ml Epinephrine, PIERREL S.P.A, Capua, Italy) in each group. Doses will be 0.1 ml, 0.2 ml, and 0.3 ml of 4% articaine with epinephrine for one appointment scaling and root planing. Anesthesia will be obtained by CCLADS device Anaject® (Septodont, Sallanches, Franc). The Intraseptal anesthesia (ISA) will be the method of administrating the anesthesia. Parameters of the device will be a mode with constant pressure, injection speed - mode LOW 0.005 ml/s. Time for application will depend on the dose, and it will be 20 s for 0.1 ml, 40 s for 0.2 ml, and 60 s for 0.3 ml.

Parameters of local anesthesia will be recorded by the pin-prick test. The pain will be rated by the visual-analogue scale (VAS). The pain will be rated immediately upon termination of the local anesthetic delivery and during the scaling and root planing.

Patients will be followed up the next day for local side effects and their need for analgesic medication.

Enrollment: 360 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age ≥ 18 years
• confirmed diagnosis of periodontitis
• presence of minimum 20 teeth
• absence of decay
• preserved tooth vitality
• good systematic health

Exclusion criteria

• allergy to articaine with 1: 100,000 epinephrine
• pregnancy
• lactation
• medication uptake that affects the periodontal supporting tissues
• acute pain, swelling, presence of gingival lesions

Trial design

360 participants in 3 patient groups

0.1 ml 4% articaine

Description:

single dose of 0.1 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing

Treatment:

Procedure: scaling and root planing

0.2 ml 4% articaine

Description:

single dose of 0.2 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing

Treatment:

Procedure: scaling and root planing

0.3 ml 4% articaine

Description:

single dose of 0.3 ml 4% articaine with 1:100,000 epinephrine delivered by computer-controlled local delivery system (Anaject), in purpose for scaling and root planing

Treatment:

Procedure: scaling and root planing