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

Efficacy of Intraseptal Anesthesia Obtained by 4 % Articaine With 1:100,000 Epinephrine Achieved by Computer-controlled Delivery System

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Periodontitis; Anesthesia, Local
• Intervention / Treatment: Procedure: scaling and root planing

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 360
• Phase: Phase 4

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Systemically healthy periodontitis patients having the indication for scaling and root planing.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
0.1 ml 4% articaine; 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	Procedure: scaling and root planing; one appointment for scaling and root planing of selected periodontal pockets, with periodontal curette (HuFriedy, Chicago, IL, USA), rinsing with saline solution
0.2 ml 4% articaine; 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	Procedure: scaling and root planing; one appointment for scaling and root planing of selected periodontal pockets, with periodontal curette (HuFriedy, Chicago, IL, USA), rinsing with saline solution
0.3 ml 4% articaine; 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	Procedure: scaling and root planing; one appointment for scaling and root planing of selected periodontal pockets, with periodontal curette (HuFriedy, Chicago, IL, USA), rinsing with saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of success anesthesia	The number of success anesthesia	1 day
Duration of soft tissue anesthesia	Time from completion of the injection until patient start filling discomfort/pain on pinprick test, measured in minutes.	1 day
Width of the anesthetic field	Distance between two needles that were not causing pain on pinprick test, measured in millimeters.	1 day
Onset time for anesthesia	Time started after completion of the injection until profound anesthesia is establish, measured in seconds.	1 day
Rate of pain during anesthetic delivery by VAS	Visual analogue scale (VAS) is a scale graded from 0 to 100 mm, where 0 is labeled for the minimum feel of pain or no pain, and 100 is labeled for maximum feel of pain (unbearable pain). Patient is placing a mark on the horizontal scale depending on the intensity of the pain sensation.	1 day
Rate of pain during scaling and root planing by VAS	Visual analogue scale (VAS) is a scale graded from 0 to 100 mm, where 0 is score for the minimum feel of pain or no pain, and 100 is score for maximum feel of pain (unbearable pain). Patient is placing a mark on the horizontal scale depending on the intensity of the pain sensation.	1 day
Presence of side effects	Record any side effects.	1 day
Analgesic medication consumption	Record number of analgesic medications.	1 day
Wich day analgesic medication is used	Wich day from intervention a analgesic medication is used	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket probing depths	Measuring the pocket probing depths by periodontal probe, in milimeteres.	1 day
Gingival margin level	Measuring the gingival margin level by periodontal probe, in milimeteres.	1 day
Clinical attachment level	Measuring the clinical attachment level by periodontal probe, measured in milimeters.	1 day
Percentage of bleeding sites	The number of sites where bleeding is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage.	1 day
Percentage of plaque index	The number of sites where plaque is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the plaque index as a percentage.	1 day

Collaborators and Investigators

• Sponsor: University of Belgrade

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2020
• Primary Completion (Estimated): December 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: May 13, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: intraseptal anesthesia; ISA; CCLADS
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: UBelgrade 36/8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no, for now, need to review conditions of terms of sharing the information

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No