Clinical trial NCT04392804: Efficacy of Intraseptal Anesthesia of 4% Articaine With Epinephrine Achieved by Computer-controlled Delivery System
Official title: Efficacy of Intraseptal Anesthesia Obtained by 4 % Articaine With 1:100,000 Epinephrine Achieved by Computer-controlled Delivery System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia, Local
Periodontitis
Keywords: intraseptal anesthesia
ISA
CCLADS
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: 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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of success anesthesia
timeFrame: 1 day
measure: Duration of soft tissue anesthesia
timeFrame: 1 day
measure: Width of the anesthetic field
timeFrame: 1 day
measure: Onset time for anesthesia
timeFrame: 1 day
measure: Rate of pain during anesthetic delivery by VAS
timeFrame: 1 day
measure: Rate of pain during scaling and root planing by VAS
timeFrame: 1 day
measure: Presence of side effects
timeFrame: 1 day
measure: Analgesic medication consumption
timeFrame: 1 day
measure: Wich day analgesic medication is used
timeFrame: 7 days
Secondary outcomes:
measure: Pocket probing depths
timeFrame: 1 day
measure: Gingival margin level
timeFrame: 1 day
measure: Clinical attachment level
timeFrame: 1 day
measure: Percentage of bleeding sites
timeFrame: 1 day
measure: Percentage of plaque index
timeFrame: 1 day
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
Study officials:
References: