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.
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
360
one appointment for scaling and root planing of selected periodontal pockets, with periodontal curette (HuFriedy, Chicago, IL, USA), rinsing with saline solution
Department of Periodontology and Oral medicine, School of Dental Medicine, University of Belgrade
Belgrade, Serbia
Number of success anesthesia
The number of success anesthesia
Time frame: 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.
Time frame: 1 day
Width of the anesthetic field
Distance between two needles that were not causing pain on pinprick test, measured in millimeters.
Time frame: 1 day
Onset time for anesthesia
Time started after completion of the injection until profound anesthesia is establish, measured in seconds.
Time frame: 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.
Time frame: 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.
Time frame: 1 day
Presence of side effects
Record any side effects.
Time frame: 1 day
Analgesic medication consumption
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Record number of analgesic medications.
Time frame: 1 day
Wich day analgesic medication is used
Wich day from intervention a analgesic medication is used
Time frame: 7 days
Pocket probing depths
Measuring the pocket probing depths by periodontal probe, in milimeteres.
Time frame: 1 day
Gingival margin level
Measuring the gingival margin level by periodontal probe, in milimeteres.
Time frame: 1 day
Clinical attachment level
Measuring the clinical attachment level by periodontal probe, measured in milimeters.
Time frame: 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.
Time frame: 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.
Time frame: 1 day