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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04392804
Acronym
EISAAECCLAD
Enrollment
360
Registered
2020-05-19
Start date
2020-05-19
Completion date
2023-12-30
Last updated
2023-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local, Periodontitis

Keywords

intraseptal anesthesia, ISA, CCLADS

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.

Interventions

PROCEDUREscaling 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

Sponsors

University of Belgrade
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Wich day analgesic medication is used7 daysWich day from intervention a analgesic medication is used
Onset time for anesthesia1 dayTime started after completion of the injection until profound anesthesia is establish, measured in seconds.
Rate of pain during anesthetic delivery by VAS1 dayVisual 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.
Rate of pain during scaling and root planing by VAS1 dayVisual 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.
Presence of side effects1 dayRecord any side effects.
Analgesic medication consumption1 dayRecord number of analgesic medications.
Width of the anesthetic field1 dayDistance between two needles that were not causing pain on pinprick test, measured in millimeters.
Number of success anesthesia1 dayThe number of success anesthesia
Duration of soft tissue anesthesia1 dayTime from completion of the injection until patient start filling discomfort/pain on pinprick test, measured in minutes.

Secondary

MeasureTime frameDescription
Gingival margin level1 dayMeasuring the gingival margin level by periodontal probe, in milimeteres.
Clinical attachment level1 dayMeasuring the clinical attachment level by periodontal probe, measured in milimeters.
Percentage of bleeding sites1 dayThe 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.
Percentage of plaque index1 dayThe 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.
Pocket probing depths1 dayMeasuring the pocket probing depths by periodontal probe, in milimeteres.

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026