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

Periodontitis Clinical Trial

— EISAAECCLAD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04392804
• Other study ID #: UBelgrade 36/8
• Status: Active, not recruiting
• Start date: May 19, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2023
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Periodontitis

Intervention

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

Locations

Country	Name	City	State
Serbia	Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of success anesthesia	The number of success anesthesia	1 day
Primary	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
Primary	Width of the anesthetic field	Distance between two needles that were not causing pain on pinprick test, measured in millimeters.	1 day
Primary	Onset time for anesthesia	Time started after completion of the injection until profound anesthesia is establish, measured in seconds.	1 day
Primary	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
Primary	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
Primary	Presence of side effects	Record any side effects.	1 day
Primary	Analgesic medication consumption	Record number of analgesic medications.	1 day
Primary	Wich day analgesic medication is used	Wich day from intervention a analgesic medication is used	7 days
Secondary	Pocket probing depths	Measuring the pocket probing depths by periodontal probe, in milimeteres.	1 day
Secondary	Gingival margin level	Measuring the gingival margin level by periodontal probe, in milimeteres.	1 day
Secondary	Clinical attachment level	Measuring the clinical attachment level by periodontal probe, measured in milimeters.	1 day
Secondary	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
Secondary	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